Phase 3: The day following the recruitment interview, all participants were mailed a screening package which included an immunochemical FOBT. Accompanying the package, intervention groups also received an implementation plan to serve as a 'cue to action' to provide a strategy for goal achievement (completion and return of the FOBT). Two intervention groups received a participant-directed plan in the form of an 'Aide' that *invited* participants to think about, and write down, how they were going to deal with potential barriers to using the FOBT. Suggestions were made as to how these barriers could be addressed. Participants in one of these two groups were asked to retain their completed plan ('*Aide to retain'*); the other group were sent two copies of the plan and requested to return one copy of the completed plan to CSIRO ('*Aide to return'*). The third intervention group received a plan in the form of a researcher-directed 'Checklist' ('*Checklist to return'*) which *directed* participants to think about how they were going to deal with potential barriers. This group was also provided with two copies of the checklist and asked to return one completed checklist to CSIRO. Thus, those in the intervention groups were invited to formulate implementation plans at differing levels of directedness, and the researchers, through their requirement that two of the intervention groups return a completed plan, were able to verify that in fact a plan had been completed. The control group received a screening package without any accompanying plan.

Phase 4: Receipt of completed FOBTs was recorded by the Bowel Health Service (Repatriation General Hospital, Bedford Park, South Australia) and participation data relayed to the researchers. People who did not return their test after six weeks were sent a reminder letter. Participation in screening was defined as receipt of kit within 6 weeks (before reminder) or after 6 weeks.

Phase 5: Approximately 7 weeks following FOBT despatch, participants were contacted by telephone. Confidence to use the FOBT was again measured, as was (for those who had returned their FOBT) commitment to screen every two years in the future, following recommended screening guidelines. Additionally, participants' reasons for screening or not screening were elicited, depending on whether a completed FOBT had been returned at the time of interview (data not included in these analyses).

#### **3.2 Materials**

72 Colorectal Cancer – From Prevention to Patient Care

**Interventions Phase 3**

FOBT screening package only (n=91)

*Aide to retain*  FOBT screening package + implementation plan to be formulated and retained by participant (n=81)

*Aide to return*  FOBT screening package + implementation plan to be formulated and returned to researcher (n=95)

*Checklist to return*  FOBT screening package + implementation plan devised by researcher completed and returned to researcher (n=97)

Phase 3: The day following the recruitment interview, all participants were mailed a screening package which included an immunochemical FOBT. Accompanying the package, intervention groups also received an implementation plan to serve as a 'cue to action' to provide a strategy for goal achievement (completion and return of the FOBT). Two intervention groups received a participant-directed plan in the form of an 'Aide' that *invited* participants to think about, and write down, how they were going to deal with potential barriers to using the FOBT. Suggestions were made as to how these barriers could be addressed. Participants in one of these two groups were asked to retain their completed plan ('*Aide to retain'*); the other group were sent two copies of the plan and requested to

Table 1. Study 1 interventions by phase and arm, with attrition rates

N=364 *Control*  **Measures Phase 4**

N=350 after exclusions (All groups)

*Measures:*  Return of kit within 6 weeks Return of kit after 6 weeks

**Measures Phase 5**

N=328 after exclusions (All groups)

*CATI interview measures:*  Commitment to rescreen Self efficacy to use FOBT Reasons for not screening (if applicable) Reasons for screening (if applicable)

**Phase 1 Recruitment**

N=1642 Potentially eligible participants randomised to study arm then notification of intention to contact by telephone + information sheet mailed

**Phase 2**

N=994 contactable. N=364 agreed to participate in CATI interview:

screen

*Baseline measures:*  Demographics Commitment to

Self efficacy to use FOBT

#### **3.2.1 Development of implementation plans**

Two versions of implementation plan were designed; one as an 'aide' and the other as a more prescriptive 'checklist'. Each version was introduced to the participant with the words "*Many people find that they intend to complete the FOBT but then forget or 'never get around to it'. It has been found that if you form a definite plan of exactly when and where you will carry out an intended behaviour you are more likely to actually do so and less likely to forget or find that you don't get around to doing it. It would be useful for you to plan when, where and how you will complete the FOBT. To help you do this, we would like you to use the attached sheets we have provided"* (adapted from Milne et al., 2002). Both plans were designed to support confidence and addressed practical aspects of completing the test (reading the instructions; deciding the most convenient time to use the FOBT; deciding the most convenient location to use the FOBT; preparing for the test; using the FOBT; remembering to use the FOBT; sending the FOBT for analysis). Both versions commenced with the instruction: "*Using this plan, decide when you will use the screening kit, where you will use the kit, and the procedure you will use to carry out the screening test and obtain your result from the Bowel Health Service*". They thereafter differed in their level of directedness in covering the practical aspects. For example, for 'remembering to use the kit' the aides contained the following instruction: "*It is easy to forget to do things unless we have a way to remind us. Decide now how you can make it easier for you to remember—for example, by leaving the kit or this plan in a prominent location, or writing yourself a note. Write below how you will remind yourself to use the kit on two separate occasions".* In contrast, for the same instruction the checklist stated "*Place a reminder in a prominent place so that you do not forget to use the kit*" with two check boxes (1st sample done; 2nd sample done) to indicate that this instruction had been carried out. The complete documents are available from the first author on request.

Turning Intention Into Behaviour: The Effect of Providing

Male Female

Highest level of education

Some high school Completed high school/trade

Country of birth:

≠n=2 missing values

Australia

University qualification

Never heard of FOBT prior to participation

\*\* n=3 missing values for age group

contemplation stage (Table 2).

**3.4.1 FOBT participation**

Control N=90 (%)

48 (53) 42

46 (51)

32 (36) 12 (13)

\*percentages have been rounded so may not be equivalent to 100%

Table 2. Study 1 Participant demographic characteristics\*

therefore available for n=328/994 (33%) participants.

Cues to Action on Participation Rates for Colorectal Cancer Screening 75

be contacted and invited to participate. Of n=994 able to be contacted and eligible, n=364 individuals (36.6%) agreed to participate in the study. Subsequently n=14 were excluded from analysis because they didn't receive an FOBT (n=3); had undergone screening since joining the study (n=4); reported symptoms that precluded them from using the FOBT (n=4), or were unable to participate due to barriers unrelated to the study (n=3). Baseline and screening participation data were therefore available for n=350/994 participants (35%).

> Aide to retain n=79 (%)

41 (52) 38

35 (45)

27 (35) 16 (20)

At follow-up (post intervention and mailing of FOBT), n=13 participants declined or were unable to be interviewed and n=9 were unable to be contacted; follow-up data were

At recruitment, the groups (n=350 participants) were balanced for gender, mean age, age group, level of education and Australian birth, and awareness of FOBT. The majority of participants had never heard of an FOBT before they were approached, i.e. they were in pre-

Completed FOBTs were returned by n=286/350 (81.7%) of eligible participants over a period of 15 weeks (mean = 3.12 weeks). Contrary to the hypothesis that formation of implementation plans would improve FOBT uptake, there was no significant difference

Age group\*\* *X*2 (6)=2.236,

Age, mean 61.1 60.5 61.2 61.7 NS

Age 50–59 43 (48) 38 (48) 45 (49) 37 (41) Age 60–69 31 (34) 29 (37) 32 (35) 39 (43) Age 70–76 15 (17) 11 (14) 14 (15) 13 (14)

Aide to return n=91 (%)

44 (48) 47

*X*2 (6)=5.894

67 (74) 57 (72) 71 (78) 61 (68) *X*2 (3)=2.539,

64 (71) 65 (82) 59 (65)≠ 65 (72) *X*2 (3)=5.618

39 (43)

36 (40) 16 (18) Checklist to return n=90 (%)

34 (38) 56

52 (58)

26 (29) 12 (13) Test of difference

p=.897

p=.435

p=.468

p=.132

*X*2 (3)=5.270, p=.153

#### **3.2.2 Development of self efficacy scale**

Self efficacy was measured using 4 items derived from terms developed by Vernon et al. (1997) and our clinical experience of the challenges and impediments surrounding FOBT use. Participants were asked to rate their degree of confidence in surmounting the barriers described. The items were scored on a 5-point Likert scale ranging from *strongly disagree* (1) to *strongly agree* (5). The items were: "I feel confident that I would be able to carry out an FOBT"; "I feel confident that the test will not be overly distasteful or embarrassing"; I feel confident that I would be able to find time in the day to complete the test"; "I feel confident that I could complete the test correctly". The scale had good internal consistency, with a Cronbach alpha coefficient of .86.

#### **3.2.3 Commitment to screen**

Commitment to screen was measured in Phase 2 by asking "*Right now, how strongly committed are you to doing this test, where 1 is undecided and 5 is very committed?".* The followup interview measured commitment to screen again (for those who had returned their FOBT): "*Now that you have done this screening test once, do you think you'll go on doing it every two years?"* (yes/no answer) and "*Right now, how strongly committed are you to doing this test again, where 1 is undecided and 5 is very committed?"*

#### **3.2.4 Screening offer**

The screening package, or kit, included (a) a bowel cancer screening information pamphlet; (b) an immunochemical FOBT ((iFOBT also known as a faecal immunochemical test for haemoglobin [FIT], InSure™, Enterix Australia) that does not require dietary or drug restrictions; (c) a combined Participant Details and Consent Form confirming personal details, nominating a preferred doctor for follow-up, and consent to obtain clinical followup reports if required; and (d) a reply-paid return envelope.

#### **3.3 Data analysis**

Random missing values on pre- and post self efficacy (SE) variables (17/2800, 0.61%) were imputed using the expectation maximisation method, so that as many observations as possible were available for computing self efficacy total scores. The scores were split at the median baseline SE score of 17; scores ≤16 were designated 'low' and scores ≥17 'high' SE. Participation rates were viewed as 'early' or 'late' at a cut-off point of 6 weeks following despatch of FOBT, at which time a reminder was sent to non-responders. Chi-square analysis was conducted to assess FOBT awareness, FOBT participation and return of implementation plans between groups; Fishers exact test was utilised where cells contained <5. Paired samples t-tests and one-way ANOVAs compared score means for self efficacy and commitment to screen. A median split was not performed for commitment to screen as the majority of people had high intention to screen. Binary logistic regression was used to examine the ability of self efficacy and commitment to screen to predict return of FOBT, and Generalised linear models (GLM) were used to assess interactions between variables. All tests were conducted using a two-sided alpha level of 0.05.

#### **3.4 Results**

Recruitment and participation attrition rates are shown at Table 1. From a sampling frame of potential participants (3,000 men and 3,000 women), n=1642 were notified that they would be contacted and invited to participate. Of n=994 able to be contacted and eligible, n=364 individuals (36.6%) agreed to participate in the study. Subsequently n=14 were excluded from analysis because they didn't receive an FOBT (n=3); had undergone screening since joining the study (n=4); reported symptoms that precluded them from using the FOBT (n=4), or were unable to participate due to barriers unrelated to the study (n=3). Baseline and screening participation data were therefore available for n=350/994 participants (35%).

\*percentages have been rounded so may not be equivalent to 100%

\*\* n=3 missing values for age group

≠n=2 missing values

74 Colorectal Cancer – From Prevention to Patient Care

Self efficacy was measured using 4 items derived from terms developed by Vernon et al. (1997) and our clinical experience of the challenges and impediments surrounding FOBT use. Participants were asked to rate their degree of confidence in surmounting the barriers described. The items were scored on a 5-point Likert scale ranging from *strongly disagree* (1) to *strongly agree* (5). The items were: "I feel confident that I would be able to carry out an FOBT"; "I feel confident that the test will not be overly distasteful or embarrassing"; I feel confident that I would be able to find time in the day to complete the test"; "I feel confident that I could complete the test correctly". The scale had good internal consistency, with a

Commitment to screen was measured in Phase 2 by asking "*Right now, how strongly committed are you to doing this test, where 1 is undecided and 5 is very committed?".* The followup interview measured commitment to screen again (for those who had returned their FOBT): "*Now that you have done this screening test once, do you think you'll go on doing it every two years?"* (yes/no answer) and "*Right now, how strongly committed are you to doing this test*

The screening package, or kit, included (a) a bowel cancer screening information pamphlet; (b) an immunochemical FOBT ((iFOBT also known as a faecal immunochemical test for haemoglobin [FIT], InSure™, Enterix Australia) that does not require dietary or drug restrictions; (c) a combined Participant Details and Consent Form confirming personal details, nominating a preferred doctor for follow-up, and consent to obtain clinical follow-

Random missing values on pre- and post self efficacy (SE) variables (17/2800, 0.61%) were imputed using the expectation maximisation method, so that as many observations as possible were available for computing self efficacy total scores. The scores were split at the median baseline SE score of 17; scores ≤16 were designated 'low' and scores ≥17 'high' SE. Participation rates were viewed as 'early' or 'late' at a cut-off point of 6 weeks following despatch of FOBT, at which time a reminder was sent to non-responders. Chi-square analysis was conducted to assess FOBT awareness, FOBT participation and return of implementation plans between groups; Fishers exact test was utilised where cells contained <5. Paired samples t-tests and one-way ANOVAs compared score means for self efficacy and commitment to screen. A median split was not performed for commitment to screen as the majority of people had high intention to screen. Binary logistic regression was used to examine the ability of self efficacy and commitment to screen to predict return of FOBT, and Generalised linear models (GLM) were used to assess interactions between variables. All

Recruitment and participation attrition rates are shown at Table 1. From a sampling frame of potential participants (3,000 men and 3,000 women), n=1642 were notified that they would

**3.2.2 Development of self efficacy scale**

Cronbach alpha coefficient of .86.

*again, where 1 is undecided and 5 is very committed?"*

up reports if required; and (d) a reply-paid return envelope.

tests were conducted using a two-sided alpha level of 0.05.

**3.2.3 Commitment to screen**

**3.2.4 Screening offer**

**3.3 Data analysis**

**3.4 Results**

Table 2. Study 1 Participant demographic characteristics\*

At follow-up (post intervention and mailing of FOBT), n=13 participants declined or were unable to be interviewed and n=9 were unable to be contacted; follow-up data were therefore available for n=328/994 (33%) participants.

At recruitment, the groups (n=350 participants) were balanced for gender, mean age, age group, level of education and Australian birth, and awareness of FOBT. The majority of participants had never heard of an FOBT before they were approached, i.e. they were in precontemplation stage (Table 2).

#### **3.4.1 FOBT participation**

Completed FOBTs were returned by n=286/350 (81.7%) of eligible participants over a period of 15 weeks (mean = 3.12 weeks). Contrary to the hypothesis that formation of implementation plans would improve FOBT uptake, there was no significant difference

Turning Intention Into Behaviour: The Effect of Providing

\*\* p<.01 \*\*\*p<.001

return/non return of FOBTs

complete initial screening, regardless of initial level of confidence.

Cues to Action on Participation Rates for Colorectal Cancer Screening 77

increased significantly, regardless of group assignment. This result suggests that, in general, confidence to complete the test in the future is likely to decrease for those people who don't

SE score non-returners (full sample) Time 1 16.77 1.893 47 1.758 Time 2 16.15 2.278

Low baseline SE score non-returners Time 1 15.46 1.208 25 0.220 Time 2 15.35 2.279

SE score returners (full sample) Time 1 17.57 1.944 279 8.674\*\*\* Time 2 18.71 1.561

Low baseline SE score returners Time 1 15.69 .978 116 15.388\*\*\* Time 2 18.32 1.711

High baseline SE score non-returners Time 1 18.32 1.287 21 2.752\*\* Time 2 17.09 1.925

High baseline SE score returners Time 1 18.92 1.202 162 0.489 Time 2 18.99 1.383

Table 5. Study 1 mean self efficacy scores pre- and post-intervention, overall and by

was decreased when the initial level was high but the test was not completed.

**3.4.4 Commitment to screen and maintain screening**

from those that had a high initial SE score (Table 7).

In order to determine whether confidence at baseline influenced reaction to the various interventions, participants were characterised as having a low or high SE score at baseline (determined by a median-split between 16 and 17), and change in confidence over time compared (See Table 5). Low SE non-returners did not significantly change their SE scores post intervention, whereas low SE returners' scores significantly increased post intervention. Similarly, for those with a high SE score at baseline, non-returners' scores significantly decreased post intervention but did not significantly change if they returned an FOBT. This latter result is likely to reflect ceiling effects given that the maximum score possible for SE was 20. These results suggest that self efficacy was increased when the test was completed but the initial level of confidence to complete the test was low, and conversely confidence

At baseline, the majority of people (n=217/343, 63%) were committed or very committed to doing the test (M=4.39, SD=.924; median=5) and there were no group differences (Table 6). Those who returned an FOBT were asked their level of commitment to maintain screening, and just over half (n=137/239, 57.3%) were "very committed" to screening again (M=4.38, SD=.840, median=5, n=47 missing values), regardless of intervention assignment. For those that did return an FOBT, a paired-sample t-test indicated that for the sample as a whole there was a statistically significant decrease in commitment to screen from baseline, ie after exposure to the intervention and FOBT (Table 7). When we examined the relationship between commitment and self efficacy by comparing commitment level between those who had a low or high SE baseline score, it was apparent that the decrease in commitment came

M SD df t

between the groups in FOBT participation or return within 6 weeks (i.e., before and after reminder) (Table 3).

\*These numbers do not correspond with participants who returned FOBTs within 6 weeks

Table 3. Study 1 return of kits and implementation plans by group

#### **3.4.2 Return of implementation plans**

Most participants who returned a completed FOBT and were also required to return a completed implementation plan did so. There was no significant difference in rate of return between aide and checklist (Table 3), suggesting that differing levels of directedness had no impact on whether the plans were completed. There were no cases of a plan being returned without an accompanying completed kit.

#### **3.4.3 Self Efficacy (SE)**

A mixed between-within subjects analysis of variance was conducted to assess the impact of the different interventions on follow-up SE scores. There was no significant interaction between intervention group and time [F(3, 324) = .874, p=.455]. There was a substantial main effect for time [F(1,324) = 46.424, p=<.005), η2 = .125] with groups showing an increase in self efficacy (Time 1, M = 17.45, SD = 1.95; Time 2, M = 18.3, SD = 1.91). The main effect comparing the groups was not significant [F(3,324) = .156, p=.93], suggesting that provision of assistance with planning did not influence SE (Table 4).

Table 4. Study 1 group mean self efficacy scores pre- and post intervention

Subsequent analyses compared self-efficacy between those who returned FOBTs and those who did not. Table 5 shows that when we compared SE over time for FOBT non-returners using a paired samples t-test there was a decrease in confidence that approached significance (*p*=.08). In other words, the confidence of non-participants to screen was impacted negatively by the provision of the FOBT. By contrast, confidence among those who returned an FOBT

increased significantly, regardless of group assignment. This result suggests that, in general, confidence to complete the test in the future is likely to decrease for those people who don't complete initial screening, regardless of initial level of confidence.

\*\* p<.01

76 Colorectal Cancer – From Prevention to Patient Care

between the groups in FOBT participation or return within 6 weeks (i.e., before and after

FOBTs returned 76 (84) 66 (84) 70 (77) 74 (82) X2 (3)=1.980,

Plans returned\* 62 66 X2 (1)=.367,

Most participants who returned a completed FOBT and were also required to return a completed implementation plan did so. There was no significant difference in rate of return between aide and checklist (Table 3), suggesting that differing levels of directedness had no impact on whether the plans were completed. There were no cases of a plan being returned

A mixed between-within subjects analysis of variance was conducted to assess the impact of the different interventions on follow-up SE scores. There was no significant interaction between intervention group and time [F(3, 324) = .874, p=.455]. There was a substantial main effect for time [F(1,324) = 46.424, p=<.005), η2 = .125] with groups showing an increase in self efficacy (Time 1, M = 17.45, SD = 1.95; Time 2, M = 18.3, SD = 1.91). The main effect comparing the groups was not significant [F(3,324) = .156, p=.93], suggesting that provision

> Aide to return mean (SD)

\*These numbers do not correspond with participants who returned FOBTs within 6 weeks

Table 3. Study 1 return of kits and implementation plans by group

Aide to return n=91 (%)

67 (74) 61 (77) 62 (68) 66 (73) X2 (3)=.869,

Checklist to return n=90 (%)

Test of difference

p=.577

p=.833

p=.545

Checklist to return

mean (SD)

Aide to retain n=79 (%)

reminder) (Table 3).

Return of kits within 6 weeks Control N=90 (%)

**3.4.2 Return of implementation plans**

without an accompanying completed kit.

of assistance with planning did not influence SE (Table 4).

Aide to retain mean (SD)

Table 4. Study 1 group mean self efficacy scores pre- and post intervention

Time 1 17.21 (1.81) 17.67 (2.03) 17.50 (1.73) 17.45 (2.22) Time 2 18.39 (2.04) 18.26 (1.98) 18.32 (1.93) 18.36 (1.73)

Subsequent analyses compared self-efficacy between those who returned FOBTs and those who did not. Table 5 shows that when we compared SE over time for FOBT non-returners using a paired samples t-test there was a decrease in confidence that approached significance (*p*=.08). In other words, the confidence of non-participants to screen was impacted negatively by the provision of the FOBT. By contrast, confidence among those who returned an FOBT

**3.4.3 Self Efficacy (SE)**

Control

mean (SD)

\*\*\*p<.001

Table 5. Study 1 mean self efficacy scores pre- and post-intervention, overall and by return/non return of FOBTs

In order to determine whether confidence at baseline influenced reaction to the various interventions, participants were characterised as having a low or high SE score at baseline (determined by a median-split between 16 and 17), and change in confidence over time compared (See Table 5). Low SE non-returners did not significantly change their SE scores post intervention, whereas low SE returners' scores significantly increased post intervention. Similarly, for those with a high SE score at baseline, non-returners' scores significantly decreased post intervention but did not significantly change if they returned an FOBT. This latter result is likely to reflect ceiling effects given that the maximum score possible for SE was 20. These results suggest that self efficacy was increased when the test was completed but the initial level of confidence to complete the test was low, and conversely confidence was decreased when the initial level was high but the test was not completed.

#### **3.4.4 Commitment to screen and maintain screening**

At baseline, the majority of people (n=217/343, 63%) were committed or very committed to doing the test (M=4.39, SD=.924; median=5) and there were no group differences (Table 6). Those who returned an FOBT were asked their level of commitment to maintain screening, and just over half (n=137/239, 57.3%) were "very committed" to screening again (M=4.38, SD=.840, median=5, n=47 missing values), regardless of intervention assignment. For those that did return an FOBT, a paired-sample t-test indicated that for the sample as a whole there was a statistically significant decrease in commitment to screen from baseline, ie after exposure to the intervention and FOBT (Table 7). When we examined the relationship between commitment and self efficacy by comparing commitment level between those who had a low or high SE baseline score, it was apparent that the decrease in commitment came from those that had a high initial SE score (Table 7).

Turning Intention Into Behaviour: The Effect of Providing

**4.1.1 Sample size and selection**

**4.1 Methods**

names were allocated.

**4.1.2 Study conduct**

deliberately ascertained.

**4.1.3 Data analysis**

**4.2 Results**

efficacy and commitment to screening.

participation data relayed to the researchers.

conducted to assess FOBT participation between groups.

Cues to Action on Participation Rates for Colorectal Cancer Screening 79

Sample selection proceeded as described for Study 1. A separate sample of 6000 men and women aged between 50 and 76 years, randomly selected from four South Australian electoral divisions, was obtained from the AEC. People residing in postcodes included in the pilot NBCSP were omitted from the sample, as were those whose address indicated they resided in a hostel or nursing home. The remaining sample was randomised separately by sex and 400 men and women were assigned sequentially to one of 4 groups. In total 1600

Phase 1: All potential participants were mailed an advance notification letter (which aligns with the protocol adopted by the NBCSP) and accompanying information as for Study 1, and were informed that they would shortly be receiving a screening package in the mail. Exclusion due to ineligibility was dependent upon self-identification and communication of this fact to the researchers before despatch of FOBT. Willingness to participate was not

Phase 2: Three weeks after the advance notification letter, a screening kit including an immunochemical FOBT was sent to individuals. As for Study 1, intervention groups also received a discrete implementation plan. The nature of this approach precluded us from ascertaining willingness to participate and from obtaining pre- and post measures of self

Phase 3: Receipt of completed FOBTs was recorded by the Bowel Health Service and

Participation rates were viewed as 'early' or 'late' at a cut-off point of 6 weeks following despatch of FOBT, when a reminder was sent to non-responders. Chi-square analysis was

N=1600 men and women were sent an advance warning letter. Those who did not identify themselves as ineligible or not wishing to participate were then mailed a screening kit and accompanying material according to intervention group. In total, n=225 were excluded from the study (n=118 identified themselves as ineligible; n=83 didn't wish to participate; n=24 packages were undeliverable). Analyses were therefore conducted for n=1375 men and

At baseline, the groups were balanced for gender (Table 9). It wasn't possible to ascertain age group breakdowns because the AEC supplied a random sample within an age range (50–74 years) which wasn't broken down into groups (for Study 1 we ascertained age from the participant). The study design also precluded us obtaining other demographic information (mean age, education, country of birth) as we did for Study 1. However, given that the underlying sampling mechanism was identical (i.e., supplied by the AEC), there is

women. Recruitment and participation attrition rates are shown at Table 8.

some confidence that the groups were balanced on these other factors.

\*Includes non-returners and returners; 7/350 missing values

\*\*Includes only those who returned an FOBT; 47/286 missing values

Table 6. Study 1 mean commitment to screen by group pre- and post intervention

\*<.05 \*\*\*<.001

Table 7. Study 1 FOBT returners' commitment to screen pre- and post-intervention, overall and by SE level at baseline

#### **3.4.5 Effect of self efficacy and commitment to screen on use of FOBT**

Logistic regression was used to assess the independent and joint effects of baseline SE and baseline commitment to screen on return of FOBT. SE alone made a statistically significant contribution, X2 (1, n=350)=11.535, p<.001, OR=1.27, CI 1.10-1.47), predicting 5.3% of the variance (Nagelkerke R squared) in screening uptake. Commitment to screen alone also made a statistically significant contribution X2 (1, n=343)=13.837, p<001, OR=1.67, CI 1.28- 2.18), and explained 6.4% of the variance. When these predictors were entered together into the logistic regression model, there was a statistically significant effect, X2(2, n=343)=17.487, p<.001), but only commitment to screen displayed a unique and statistically significant contribution (p=.012, OR=1.46, CI 1.07-1.97); baseline self efficacy was marginally significant (p=.06, OR=1.17, CI.993-1.37). This suggests that those who are committed to using the FOBT will do so regardless of their level of confidence. The total variance explained by the combined model was R2=8.0%, indicating that factors other than these also contribute to the likelihood of completing an FOBT.

#### **4. Study 2**

Study 2 was conducted to examine the generalisability of Study 1's results to the broader population. This approach more closely approximated that undertaken in current population screening programs utilising FOBTs.

#### **4.1 Methods**

78 Colorectal Cancer – From Prevention to Patient Care

Checklist to return mean (SD)

ANOVA

(3, 339)

(3,235)

M SD df t

Time 1 4.20 0.947 98 -1.522 Time 2 4.36 0.814

133 4.485\*\*\* Time 2 4.39 0.866

Time 1 4.76 0.578

.087

.294

Aide to return mean (SD)

*F*, (df) p

Table 6. Study 1 mean commitment to screen by group pre- and post intervention

Commitment to screen (full sample, n=233) Time 1 4.52 0.804 232 2.15\* Time 2 4.38 0.843

Table 7. Study 1 FOBT returners' commitment to screen pre- and post-intervention, overall

Logistic regression was used to assess the independent and joint effects of baseline SE and baseline commitment to screen on return of FOBT. SE alone made a statistically significant contribution, X2 (1, n=350)=11.535, p<.001, OR=1.27, CI 1.10-1.47), predicting 5.3% of the variance (Nagelkerke R squared) in screening uptake. Commitment to screen alone also made a statistically significant contribution X2 (1, n=343)=13.837, p<001, OR=1.67, CI 1.28- 2.18), and explained 6.4% of the variance. When these predictors were entered together into the logistic regression model, there was a statistically significant effect, X2(2, n=343)=17.487, p<.001), but only commitment to screen displayed a unique and statistically significant contribution (p=.012, OR=1.46, CI 1.07-1.97); baseline self efficacy was marginally significant (p=.06, OR=1.17, CI.993-1.37). This suggests that those who are committed to using the FOBT will do so regardless of their level of confidence. The total variance explained by the combined model was R2=8.0%, indicating that factors other than these also contribute to the

Study 2 was conducted to examine the generalisability of Study 1's results to the broader population. This approach more closely approximated that undertaken in current

**3.4.5 Effect of self efficacy and commitment to screen on use of FOBT**

4.48 (.844) 4.57 (.854) 4.33 (.974) 4.23 (.984) 2.21

4.41 (.938) 4.33 (.816) 4.53 (.704) 4.24 (.878) 1.25

Control

Time 1\* (n=343)

Time 2\*\* (n=239)

(n=99)

(n=134)

and by SE level at baseline

likelihood of completing an FOBT.

population screening programs utilising FOBTs.

**4. Study 2**

\*<.05 \*\*\*<.001 mean (SD)

Aide to retain mean (SD)

\*Includes non-returners and returners; 7/350 missing values \*\*Includes only those who returned an FOBT; 47/286 missing values

Low baseline SE score commitment to screen

High baseline SE score commitment to screen

#### **4.1.1 Sample size and selection**

Sample selection proceeded as described for Study 1. A separate sample of 6000 men and women aged between 50 and 76 years, randomly selected from four South Australian electoral divisions, was obtained from the AEC. People residing in postcodes included in the pilot NBCSP were omitted from the sample, as were those whose address indicated they resided in a hostel or nursing home. The remaining sample was randomised separately by sex and 400 men and women were assigned sequentially to one of 4 groups. In total 1600 names were allocated.

#### **4.1.2 Study conduct**

Phase 1: All potential participants were mailed an advance notification letter (which aligns with the protocol adopted by the NBCSP) and accompanying information as for Study 1, and were informed that they would shortly be receiving a screening package in the mail. Exclusion due to ineligibility was dependent upon self-identification and communication of this fact to the researchers before despatch of FOBT. Willingness to participate was not deliberately ascertained.

Phase 2: Three weeks after the advance notification letter, a screening kit including an immunochemical FOBT was sent to individuals. As for Study 1, intervention groups also received a discrete implementation plan. The nature of this approach precluded us from ascertaining willingness to participate and from obtaining pre- and post measures of self efficacy and commitment to screening.

Phase 3: Receipt of completed FOBTs was recorded by the Bowel Health Service and participation data relayed to the researchers.

#### **4.1.3 Data analysis**

Participation rates were viewed as 'early' or 'late' at a cut-off point of 6 weeks following despatch of FOBT, when a reminder was sent to non-responders. Chi-square analysis was conducted to assess FOBT participation between groups.

#### **4.2 Results**

N=1600 men and women were sent an advance warning letter. Those who did not identify themselves as ineligible or not wishing to participate were then mailed a screening kit and accompanying material according to intervention group. In total, n=225 were excluded from the study (n=118 identified themselves as ineligible; n=83 didn't wish to participate; n=24 packages were undeliverable). Analyses were therefore conducted for n=1375 men and women. Recruitment and participation attrition rates are shown at Table 8.

At baseline, the groups were balanced for gender (Table 9). It wasn't possible to ascertain age group breakdowns because the AEC supplied a random sample within an age range (50–74 years) which wasn't broken down into groups (for Study 1 we ascertained age from the participant). The study design also precluded us obtaining other demographic information (mean age, education, country of birth) as we did for Study 1. However, given that the underlying sampling mechanism was identical (i.e., supplied by the AEC), there is some confidence that the groups were balanced on these other factors.

Turning Intention Into Behaviour: The Effect of Providing

**4.2.2 Return of implementation plans**

**5. Discussion**

evidence of the use of these plans.

Cues to Action on Participation Rates for Colorectal Cancer Screening 81

A considerable proportion of those who returned an FOBT and were also required to return a completed implementation plan did not do so, and significantly fewer people returned the prescriptive plan (i.e., checklist) than the aide (Table 10), suggesting that level of directedness may have an effect on whether the plans were completed—those who were required to formulate their own plan based on suggestions for action were more likely to return a plan compared to those given a prescriptive checklist. Notwithstanding this result, given that the requirement for return was to act as an indicator of whether plans had actually been formulated, it appears that around half the participants used the FOBT without adhering to

We hypothesised that the formation of implementation plans would assist return of FOBT kits by providing a physical cue to action. In addition we hypothesised that the process of completing a plan would increase confidence in ability to complete the test and that those who were strongly committed to screening at baseline would differ in formation of implementation plans and participation to those with a less strong initial commitment. Notwithstanding the difference in overall participation figures between Study 1 (81.7%) and Study 2 (39.9%), we found that for both studies provision of assistance with planning, regardless of directedness, had no influence on completion of an FOBT. The lack of influence of an implementation plan concurs with the conclusions of other researchers who have also found no effect of implementation planning on subsequent behaviour (Jackson et al., 2005; Michie et al., 2004; Rutter et al., 2006; Skar et al., 2011). Even so, this result goes against the large body of evidence suggesting that formulating action plans has a positive effect on the intention-behaviour gap. It has been suggested, however, that there exists sparse evidence for a positive effect of implementation intentions on behaviours outside student samples, who are more likely to comply with task demands (actually formulating the plan) (Jackson et al., 2005; Schweiger Gallo & Gollwitzer, 2007). It has also been argued that implementation plans are only effective where there is motivation to achieve a goal (Sniehotta, 2009) and that where goal intentions are positive, so will be the effects of implementation intentions (Gollwitzer, 1993; Oettingen et al., 2000). The majority of FOBT returners in Study 1 already had a high intention to screen, which may be attributable to the fact that that they had made a conscious decision to participate and were presumably more motivated to act, but in any case there was no evidence of a differential effect of combining high commitment with formation of implementation plans on FOBT return. Indeed, the high proportion of implementation plans returned by Study 1 participants (82%) may be indicative only of compliance with the study requirements (i.e., to return plans) rather than

However, and in contrast to Study 1, it is evident that nearly half the FOBTs returned in Study 2 were completed without making a plan, a result which could reasonably be extrapolated to the group that was asked to retain their formulated plan. It has been suggested that non-completion may reflect ambiguity of study instructions (Michie et al., 2004) but, given that nearly all Study 1 participants returned identically-constructed implementation plans with a completed FOBT, this was not the case in our population. Rather, this outcome suggests that some felt they had no need to complete plans, perhaps because their intentions were sufficiently strong to make the use of plans unnecessary.

planning instructions, particularly those who received a prescriptive plan.

Table 8. Study 2 interventions by phase and arm, with attrition rates

Table 9. Study 2 participant demographic characteristics

#### **4.2.1 FOBT participation**

Completed FOBTs were returned by 548/1375 (39.9%) of participants over a period of 26 weeks (mean = 5.51 weeks). This rate is similar to that achieved in the NBCSP in 2008 (i.e., 41% (AIHW, 2010). As for Study 1, contrary to our hypothesis that the formation of implementation plans would improve FOBT uptake, there was no significant difference between the groups in FOBT participation or return within 6 weeks (before and after reminder) (Table 10).

Table 10. Study 2 overall return of kits and within 6 weeks (i.e. before reminder) by group

#### **4.2.2 Return of implementation plans**

A considerable proportion of those who returned an FOBT and were also required to return a completed implementation plan did not do so, and significantly fewer people returned the prescriptive plan (i.e., checklist) than the aide (Table 10), suggesting that level of directedness may have an effect on whether the plans were completed—those who were required to formulate their own plan based on suggestions for action were more likely to return a plan compared to those given a prescriptive checklist. Notwithstanding this result, given that the requirement for return was to act as an indicator of whether plans had actually been formulated, it appears that around half the participants used the FOBT without adhering to planning instructions, particularly those who received a prescriptive plan.

#### **5. Discussion**

80 Colorectal Cancer – From Prevention to Patient Care

FOBT screening package + implementation plan to be formulated and retained by participant (n=400)

FOBT screening package + implementation plan to be formulated and returned to researcher (n=400)

FOBT screening package + implementation plan devised by researcher to be completed and

> Checklist to return n=346 (%)

178 (51.4) 168

Test of difference

*X*2 (3)=0.96, p=.992

> Test of difference

p=.652

p=.352

p=.001

62/142 (43.6) X2 (1)=9.389,

FOBT screening package only (n=400)

**Measures Phase 3**

(All groups, n=1375) Return of kit within and after 6 weeks

**Interventions Phase 2**

*Aide to retain*

*Aide to return*

*Checklist to return*

Table 8. Study 2 interventions by phase and arm, with attrition rates

Aide to retain n=350 (%)

176 (50.3) 174

Table 9. Study 2 participant demographic characteristics

n=345 (%)

returned to researcher (n=400)

Aide to return n=334 (%)

170 (50.9) 164

Aide to retain n=350 (%)

83/131

Completed FOBTs were returned by 548/1375 (39.9%) of participants over a period of 26 weeks (mean = 5.51 weeks). This rate is similar to that achieved in the NBCSP in 2008 (i.e., 41% (AIHW, 2010). As for Study 1, contrary to our hypothesis that the formation of implementation plans would improve FOBT uptake, there was no significant difference between the groups in FOBT participation or return within 6 weeks (before and after

FOBTs returned 144 (41.7) 131 (37.4) 131 (39.2) 142 (41.0) X2(3)=1.633,

Table 10. Study 2 overall return of kits and within 6 weeks (i.e. before reminder) by group

Aide to return n=334 (%)

(58.4)

106 (30.7) 98 (28.0) 97 (29.0) 94 (27.2) X2 (3)=3.269,

Checklist to return n=346 (%)

*Control*

**Recruitment Phase 1**

Potentially eligible participants randomised to study arm then mailed information

(Control)

Male Female n=345 (%)

176 (51.0) 169

**4.2.1 FOBT participation**

reminder) (Table 10).

Return of kits within 6 weeks

Return of plans with FOBT

Control

N=1600

sheet and notification that they would shortly receive an FOBT kit. Ineligibility was defined and dependent upon self-report

We hypothesised that the formation of implementation plans would assist return of FOBT kits by providing a physical cue to action. In addition we hypothesised that the process of completing a plan would increase confidence in ability to complete the test and that those who were strongly committed to screening at baseline would differ in formation of implementation plans and participation to those with a less strong initial commitment.

Notwithstanding the difference in overall participation figures between Study 1 (81.7%) and Study 2 (39.9%), we found that for both studies provision of assistance with planning, regardless of directedness, had no influence on completion of an FOBT. The lack of influence of an implementation plan concurs with the conclusions of other researchers who have also found no effect of implementation planning on subsequent behaviour (Jackson et al., 2005; Michie et al., 2004; Rutter et al., 2006; Skar et al., 2011). Even so, this result goes against the large body of evidence suggesting that formulating action plans has a positive effect on the intention-behaviour gap. It has been suggested, however, that there exists sparse evidence for a positive effect of implementation intentions on behaviours outside student samples, who are more likely to comply with task demands (actually formulating the plan) (Jackson et al., 2005; Schweiger Gallo & Gollwitzer, 2007). It has also been argued that implementation plans are only effective where there is motivation to achieve a goal (Sniehotta, 2009) and that where goal intentions are positive, so will be the effects of implementation intentions (Gollwitzer, 1993; Oettingen et al., 2000). The majority of FOBT returners in Study 1 already had a high intention to screen, which may be attributable to the fact that that they had made a conscious decision to participate and were presumably more motivated to act, but in any case there was no evidence of a differential effect of combining high commitment with formation of implementation plans on FOBT return. Indeed, the high proportion of implementation plans returned by Study 1 participants (82%) may be indicative only of compliance with the study requirements (i.e., to return plans) rather than evidence of the use of these plans.

However, and in contrast to Study 1, it is evident that nearly half the FOBTs returned in Study 2 were completed without making a plan, a result which could reasonably be extrapolated to the group that was asked to retain their formulated plan. It has been suggested that non-completion may reflect ambiguity of study instructions (Michie et al., 2004) but, given that nearly all Study 1 participants returned identically-constructed implementation plans with a completed FOBT, this was not the case in our population. Rather, this outcome suggests that some felt they had no need to complete plans, perhaps because their intentions were sufficiently strong to make the use of plans unnecessary.

Turning Intention Into Behaviour: The Effect of Providing

with the pre-contemplation stage.

**7. Acknowledgements**

**8. References**

**6. Conclusion**

Cues to Action on Participation Rates for Colorectal Cancer Screening 83

The low rate of participation in Study 2 may reflect a dissonance of messages appropriate to an individual's stage of readiness to screen (Prochaska, 2008). The differences in study design, particularly recruitment strategy, between studies 1 and 2 may have resulted in basic sample differences in stage of readiness to screen at baseline. Specifically, including only participants prepared to complete questionnaires in Study 1 resulted in a highly committed sample, likely to be in contemplation or preparation to act stage, characterised by a high participation rate. By contrast, Study 2 invitees were a population sample, most of who were probably in pre-contemplation on receipt of the FOBT, with participation rates comparable with those achieved by the national screening program (i.e. ~ 40%). Precontemplation is a stage where it could be argued that a person's knowledge, attitudes and intentions are in a more unstable state. People in this stage have been shown to have higher barriers, higher chance health locus of control, low powerful others health locus of control, lower perceived susceptibility and lower CRC knowledge (Gregory et al., 2011). It follows that these factors should be addressed to facilitate movement through contemplation to the action stage. However, our implementation plans as formulated were aimed at those with an intention to act and focused on the where, when and how of successful completion of the FOBT. It could be daunting for those who had never heard of FOBT screening to receive a test and accompanying material designed to assist with completing the test without first being given information aimed at overcoming barriers and lack of knowledge associated

The provision of assistance with the preparation of implementation plans, regardless of their level of directedness, had no influence on FOBT participation in the 2 studies conducted. One reason for their lack of effect may be that the majority of participants were likely to be in pre-contemplation stage in Study 2 and in the action stage in Study 1. Thus ceiling effects limited the potential for cues to impact behaviour among participants in Study 1, and Study 2 participants may have benefited from an intervention that tackled Contemplation as an intermediary to Action. This stage mismatch has implications for population-based screening programs and may contribute toward less than optimal screening uptake rates. Future research could usefully address the potential for the communication within a population setting of material targeted to specific decision stages, designed to progressively move an individual toward action and maintenance of action. Our research indicated that confidence to screen and commitment to screen separately and together exerted a greater influence on actual FOBT participation; however, these factors accounted for a small amount

of variance and future research should address the contribution of other factors.

AIHW. (2010). *National Bowel Cancer Screening Program: Annual monitoring report 2009; Data*

*supplement 2010*. Canberra: Australian Institute of Health and Welfare & Australian

We would like to thank Ian Zajac, CSIRO, for timely statistical advice.

Department of Health and Ageing

Indeed, we found from Study 1 that commitment had the most significant influence on FOBT use—because the majority of participants were strongly committed, we were unable to determine if having a weak level of commitment would influence formulation of an implementation plan or use of the FOBT. Of those Study 2 participants that did formulate and return plans, significantly fewer used the prescriptive 'checklist' format. Participants may have been "turned off" by the directedness of the checklist, particularly since they were a population sample and had not made a mindful decision to participate in a study. Study 1 demonstrated that provision of directions did not increase people's self efficacy. These results accord with a meta-analysis of 66 randomised controlled studies that concluded that forming implementation intentions had negligible effects on self efficacy and goal intentions (Webb & Sheeran, 2008).

For the group as a whole, baseline self efficacy did not have a strong influence on whether people used the test; rather, the act itself of completing the FOBT determined confidence—self efficacy was increased when the initial level of confidence to complete the FOBT was low, and conversely confidence was decreased when the initial level was high but the test was not completed. Rather than confidence to use the FOBT, from Study 1 it appears that being initially committed to screening had a more significant influence on whether people actually did use the FOBT, confirming the general consensus that intention to perform a behaviour is a necessary precursor of action. Even so, we found in Study 1 that commitment to screening, while a significant predictor of FOBT use, in conjunction with self efficacy explained only 8.0% of the variance, indicating that other factors exist which contribute to the likelihood of completing an FOBT. For example, Gregory et al. (2011) found that social-cognitive predictors of intention to screen for CRC and actual screening behaviour, although overlapping, were not the same, and Power and colleagues (2008) in their study of CRC screening found that life difficulty variables were better predictors of action than intention.

It is puzzling to note that there was a significant decrease in commitment to repeat screening by those that did use the FOBT and had a high initial level of confidence, in contrast to those with low confidence whose level of commitment to screening did not change. It may be that initial commitment was high for most because the participants were an 'interested' sample, and that those with high SE who screened reinforced their view that they were capable of completing an FOBT without necessarily moving from that conclusion and forming a commitment to rescreen. Conversely, those with low confidence but who did complete their test, thereby increasing their confidence, could have felt 'motivated' to repeat the experience again and so not changed their level of commitment. Interestingly, the same lessening of intention by those with high self efficacy was noted in a study examining the role of self efficacy in testicular self-examination (Umeh & Chadwick, 2010). The researchers found that those with high self efficacy appeared to have worsened attitudes toward self examination when both vulnerability and severity estimates were low. The same situation could well apply to CRC screening, particularly as perceived susceptibility is a Preventive Health Model (PHM) construct demonstrated to be associated with CRC screening ((Flight et al., 2010; Tiro et al., 2005). Commitment to future CRC screening in one or 2 years would perhaps, as Umeh and Chadwick (2010) have suggested, be temporarily rejected if the penalties of inaction are deemed insignificant, a viewpoint which may stem from a defensive reaction activated by anxiety. This view suggests that an emphasis on the development of messages designed to increase perceptions of personal risk of CRC without raising anxiety are warranted.

The low rate of participation in Study 2 may reflect a dissonance of messages appropriate to an individual's stage of readiness to screen (Prochaska, 2008). The differences in study design, particularly recruitment strategy, between studies 1 and 2 may have resulted in basic sample differences in stage of readiness to screen at baseline. Specifically, including only participants prepared to complete questionnaires in Study 1 resulted in a highly committed sample, likely to be in contemplation or preparation to act stage, characterised by a high participation rate. By contrast, Study 2 invitees were a population sample, most of who were probably in pre-contemplation on receipt of the FOBT, with participation rates comparable with those achieved by the national screening program (i.e. ~ 40%). Precontemplation is a stage where it could be argued that a person's knowledge, attitudes and intentions are in a more unstable state. People in this stage have been shown to have higher barriers, higher chance health locus of control, low powerful others health locus of control, lower perceived susceptibility and lower CRC knowledge (Gregory et al., 2011). It follows that these factors should be addressed to facilitate movement through contemplation to the action stage. However, our implementation plans as formulated were aimed at those with an intention to act and focused on the where, when and how of successful completion of the FOBT. It could be daunting for those who had never heard of FOBT screening to receive a test and accompanying material designed to assist with completing the test without first being given information aimed at overcoming barriers and lack of knowledge associated with the pre-contemplation stage.

#### **6. Conclusion**

82 Colorectal Cancer – From Prevention to Patient Care

Indeed, we found from Study 1 that commitment had the most significant influence on FOBT use—because the majority of participants were strongly committed, we were unable to determine if having a weak level of commitment would influence formulation of an implementation plan or use of the FOBT. Of those Study 2 participants that did formulate and return plans, significantly fewer used the prescriptive 'checklist' format. Participants may have been "turned off" by the directedness of the checklist, particularly since they were a population sample and had not made a mindful decision to participate in a study. Study 1 demonstrated that provision of directions did not increase people's self efficacy. These results accord with a meta-analysis of 66 randomised controlled studies that concluded that forming implementation intentions had negligible effects on self efficacy and goal intentions

For the group as a whole, baseline self efficacy did not have a strong influence on whether people used the test; rather, the act itself of completing the FOBT determined confidence—self efficacy was increased when the initial level of confidence to complete the FOBT was low, and conversely confidence was decreased when the initial level was high but the test was not completed. Rather than confidence to use the FOBT, from Study 1 it appears that being initially committed to screening had a more significant influence on whether people actually did use the FOBT, confirming the general consensus that intention to perform a behaviour is a necessary precursor of action. Even so, we found in Study 1 that commitment to screening, while a significant predictor of FOBT use, in conjunction with self efficacy explained only 8.0% of the variance, indicating that other factors exist which contribute to the likelihood of completing an FOBT. For example, Gregory et al. (2011) found that social-cognitive predictors of intention to screen for CRC and actual screening behaviour, although overlapping, were not the same, and Power and colleagues (2008) in their study of CRC screening found that life difficulty variables were

It is puzzling to note that there was a significant decrease in commitment to repeat screening by those that did use the FOBT and had a high initial level of confidence, in contrast to those with low confidence whose level of commitment to screening did not change. It may be that initial commitment was high for most because the participants were an 'interested' sample, and that those with high SE who screened reinforced their view that they were capable of completing an FOBT without necessarily moving from that conclusion and forming a commitment to rescreen. Conversely, those with low confidence but who did complete their test, thereby increasing their confidence, could have felt 'motivated' to repeat the experience again and so not changed their level of commitment. Interestingly, the same lessening of intention by those with high self efficacy was noted in a study examining the role of self efficacy in testicular self-examination (Umeh & Chadwick, 2010). The researchers found that those with high self efficacy appeared to have worsened attitudes toward self examination when both vulnerability and severity estimates were low. The same situation could well apply to CRC screening, particularly as perceived susceptibility is a Preventive Health Model (PHM) construct demonstrated to be associated with CRC screening ((Flight et al., 2010; Tiro et al., 2005). Commitment to future CRC screening in one or 2 years would perhaps, as Umeh and Chadwick (2010) have suggested, be temporarily rejected if the penalties of inaction are deemed insignificant, a viewpoint which may stem from a defensive reaction activated by anxiety. This view suggests that an emphasis on the development of messages designed to increase perceptions of personal risk of CRC without

(Webb & Sheeran, 2008).

better predictors of action than intention.

raising anxiety are warranted.

The provision of assistance with the preparation of implementation plans, regardless of their level of directedness, had no influence on FOBT participation in the 2 studies conducted. One reason for their lack of effect may be that the majority of participants were likely to be in pre-contemplation stage in Study 2 and in the action stage in Study 1. Thus ceiling effects limited the potential for cues to impact behaviour among participants in Study 1, and Study 2 participants may have benefited from an intervention that tackled Contemplation as an intermediary to Action. This stage mismatch has implications for population-based screening programs and may contribute toward less than optimal screening uptake rates. Future research could usefully address the potential for the communication within a population setting of material targeted to specific decision stages, designed to progressively move an individual toward action and maintenance of action. Our research indicated that confidence to screen and commitment to screen separately and together exerted a greater influence on actual FOBT participation; however, these factors accounted for a small amount of variance and future research should address the contribution of other factors.

#### **7. Acknowledgements**

We would like to thank Ian Zajac, CSIRO, for timely statistical advice.

#### **8. References**

AIHW. (2010). *National Bowel Cancer Screening Program: Annual monitoring report 2009; Data supplement 2010*. Canberra: Australian Institute of Health and Welfare & Australian Department of Health and Ageing

Turning Intention Into Behaviour: The Effect of Providing

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*Psychology,* Vol. 4, pp. 141-185, ISSN 1046-3283

*Medicine,* Vol. 60, pp. 2382-2391, ISSN 0037-7856

Vol. 38, pp. 69-119, ISSN 0065-2601

*From cognition to behavior*, J. Kuhl & J. Beckman (Eds.), (pp. 11-39), ISBN 978-038-

dietary compliance: A field experiment. *Journal of Health and Social Behaviour,* Vol.

*Social Cognition Models* (2nd ed.). ISBN 13 978 0335 21176 0, Maidenhead, UK: Open

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Cancer Screening: Another Approach to Following the Guidelines. *Cancer Epidemiology Biomarkers & Prevention,* Vol. 15, No. 1, pp. 108-113, ISSN 1055-9965 Flight, I.; Wilson, C.; McGillivray, J. & Myers, R. (2010). Cross-cultural validation of the

Preventive Health Model for colorectal cancer screening: An Australian study.

colorctal cancer in the general population. *JAMA,* Vol. 284, pp. 1954-1961, ISSN

meta-analysis of effects and processes. *Advances in Experimental Social Psychology,*

social cognitive and social ecological predictors of intention and participation in screening for colorectal cancer. *BMC Public Health,* Vol. 11, pp. 38, ISSN 1471-2458 Hardcastle, J.; Chamberlain, J.; Robinson, M.; Moss, S.; Amar, S.; Balfour, T.; James, P. &

Mangham, C. (1996). Randomised controlled trial of faecal-occult-blood screening

*cancer using the faecal occult blood test, Hemoccult*: Cochrane Database of Systematic Reviews Issue 1. Art. No.: CD001216. DOI: 10.1002/14651858.CD001216.pub2 International Cancer Screening Network. (2008). Inventory of Colorectal Cancer Screening

Activities in ICSN Countries, May 2008. Retrieved 22 June 2011, from

Beyond intention: do specific plans increase health behaviours in patients in primary care? A study of fruit and vegetable consumption. *Social Science &*

biennial screening with a faecal occult blood test: results after nine screening

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**5**

Hitoshi Okamura *Hiroshima University,*

*Japan*

**Psychological Impact and Associated**

**Results Concerning Hereditary**

**Nonpolyposis Colorectal Cancer**

**Factors After Disclosure of Genetic Test**

Advances in genetics in recent years have made major contributions to the development of medical genetics. The existence of "familial tumors" has been recognized, and genetic testing, with a potentially incalculable benefit to humanity, is being attempted (Offit, 1998). Numerous gene analyses related to the genesis and development of colorectal cancer have been conducted, and the existence of hereditary colorectal tumors in the form of hereditary nonpolyposis colorectal cancer (HNPCC) and familial adenomatous polyposis (FAP) has

HNPCC is caused by inherited germline mutations in mismatch repair genes and accounts for 2 -5% of colorectal cancers. The condition is characterized by young-onset, synchronous and metachronous tumors, and a predisposition to gynecologic, urinary tract, and extracolonic gastrointestinal cancers. Genetic testing usually begins with a family member who has been diagnosed with an HNPCC syndrome-related cancer (proband). If a deleterious mutation is identified, testing can be offered to the proband's family members, since they are at risk of carrying the mutation. Knowing one's genetic risk for hereditary

However, in contrast to the advances in scientific techniques, a great deal of apprehension exists with regard to the psychological or ethical, legal, and social issues (ELSI) associated with the application of these techniques. Since important personal genetic information that does not change throughout one's lifetime is handled during genetic diagnosis and an individual's genetic information is partly shared with blood relatives, with the impact of such genetic information not being limited to the individual, we find ourselves in a situation where new life health-care norms that also take psychosocial aspects into consideration are required. For this reason, a variety of studies have been conducted regarding the psychosocial aspects involved in the screening-test-taking behavior of high-risk people, the psychological aspects of high-risk people, interest in genetic counseling and genetic testing, and the psychosocial effects of genetic counseling. Studies on psychosocial aspects after being informed of the test results have also been reported recently, but many of these studies are concerning hereditary breast and ovarian cancer, and very few studies

cancers may facilitate the early detection or prevention of cancer.

**1. Introduction**

been identified.

randomised controlled trial. *Psychology and Health,* Vol. 26, No. 4, pp. 399-417, ISSN 0887-0446

### **Psychological Impact and Associated Factors After Disclosure of Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer**

Hitoshi Okamura *Hiroshima University, Japan*

#### **1. Introduction**

86 Colorectal Cancer – From Prevention to Patient Care

Sniehotta, F. (2009). towards a theory of intentional behaviour change: Plans, planning, and

Tiro, J.; Vernon, S.; Hyslop, T. & Myers, R. (2005). Factorial validity and invariance of a

Umeh, K. & Chadwick, R. (2010). Early detection of testicular cancer: revsiting the role of

Vernon, S.; Myers, R. & Tilley, B. (1997). Development and validation of an instrument to

*Epidemiology Biomarkers & Prevention,* Vol. 12, pp. 339-349, ISSN 1573-3521 Verplanken, B. & Faes, S. (1999). Good intentions, bad habits, and effects of forming

Webb, T. & Sheeran, P. (2006). Does changing behavioral intentions engender behavior

Webb, T. & Sheeran, P. (2008). Mechanisms of implementation intention effects: The role of

Weller, D.; Moss, S.; Butler, P.; Campbell, C.; Coleman, D.; Melia, J. & Robertson, R. (2006).

*the Department of Health*. Edinburgh: University of Edinburgh. UK.

0887-0446

1359-107X

ISSN 1573-3521

Vol. 14, pp. 2855-286, ISSN 1573-3521

Vol. 29, pp. 592-604, ISSN 1046-3283

132, No. 2, pp. 249-268, ISSN 0033-2909

*Social Psychology,* Vol. 47, pp. 373-395, ISSN 2044-8309

randomised controlled trial. *Psychology and Health,* Vol. 26, No. 4, pp. 399-417, ISSN

self-regulation. *British Journal of Health Psychology,* Vol. 14, No., pp. 261-273, ISSN

survey measuring psychosocial correlates of colorectal cancer screening among African Americans and Caucasians. *Cancer Epidemiology Biomarkers & Prevention,*

self-efficacy in testicular self-examination among young asymptomatic males [Epub ahead of print]. *Journal of Behavioral Medicine,* published online 22 April 2010,

measure factors related to colorectal cancer screening adherence. *Cancer*

implementation intentions on healthy eating. *European Review of Social Psychology,*

change? A meta-analysis of the experimental evidence. *Psychological Bulletin,* Vol.

goal intentions, self-efficacy, and accessibility of plan components. *British Journal of*

*English Pilot of Bowel Cancer Screening: an evaluation of the second round. Final Report to*

Advances in genetics in recent years have made major contributions to the development of medical genetics. The existence of "familial tumors" has been recognized, and genetic testing, with a potentially incalculable benefit to humanity, is being attempted (Offit, 1998). Numerous gene analyses related to the genesis and development of colorectal cancer have been conducted, and the existence of hereditary colorectal tumors in the form of hereditary nonpolyposis colorectal cancer (HNPCC) and familial adenomatous polyposis (FAP) has been identified.

HNPCC is caused by inherited germline mutations in mismatch repair genes and accounts for 2 -5% of colorectal cancers. The condition is characterized by young-onset, synchronous and metachronous tumors, and a predisposition to gynecologic, urinary tract, and extracolonic gastrointestinal cancers. Genetic testing usually begins with a family member who has been diagnosed with an HNPCC syndrome-related cancer (proband). If a deleterious mutation is identified, testing can be offered to the proband's family members, since they are at risk of carrying the mutation. Knowing one's genetic risk for hereditary cancers may facilitate the early detection or prevention of cancer.

However, in contrast to the advances in scientific techniques, a great deal of apprehension exists with regard to the psychological or ethical, legal, and social issues (ELSI) associated with the application of these techniques. Since important personal genetic information that does not change throughout one's lifetime is handled during genetic diagnosis and an individual's genetic information is partly shared with blood relatives, with the impact of such genetic information not being limited to the individual, we find ourselves in a situation where new life health-care norms that also take psychosocial aspects into consideration are required. For this reason, a variety of studies have been conducted regarding the psychosocial aspects involved in the screening-test-taking behavior of high-risk people, the psychological aspects of high-risk people, interest in genetic counseling and genetic testing, and the psychosocial effects of genetic counseling. Studies on psychosocial aspects after being informed of the test results have also been reported recently, but many of these studies are concerning hereditary breast and ovarian cancer, and very few studies

Psychological Impact and Associated Factors After Disclosure of

aid, is needed.

HNPCC.

**3. Risk perception**

perceived risk was unchanged.

Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer 89

however, concerns about psychological and psychosocial issues may present barriers to undergoing genetic testing. The development of patient education tools, such as the decision

HNPCC mutation carriers have a life-time risk of colorectal cancer of about 80%, while female carriers have a 40-60% risk of endometrial cancer and a 10-15% risk of ovarian cancer. Communicating cancer risk and assessing the perceived risk is very important for genetic counseling because of subsequent cancer prevention behavior or cancer-related distress. Four reports were extracted regarding risk perception among individuals at risk for

Codori et al. (2005) assessed the effect of genetic counseling on perceived lifetime risk and cancer-distress among 101 adult first-degree-relatives of colorectal cancer patients from families with known or suspected HNPCC. Most persons overestimated their cancer risk, and a higher perceived risk was associated with believing that colorectal cancer cannot be prevented. The individual perceived risk changed after counseling, although the mean

Domanska et al. (2007) investigated the perceived cancer risk among 47 HNPCC mutation carriers and correlated the findings with individual characteristics. A perceived risk of colorectal cancer above 60% was reported by 49% individuals, and only one reported a perceived risk > 80%. Female mutation carriers, individuals under the age of 50 years, and individuals who received their counseling within 1 year prior to the study reported a higher perceived risk of colorectal cancer. Individuals who had lost a parent to HNPCC-related cancer at an early age also reported a higher perceived risk. Regarding gynecological cancer, 33% of the women reported a perceived risk of 40-60% for endometrial cancer, whereas the

van Oostrom et al. (2007) studied the difference in cancer risk perception among 271 individuals who opted for genetic cancer susceptibility testing for a known familial BRCA1/2 or HNPCC related germline mutation. The assessment was conducted before, 1 week after, and 6 months after disclosure of the test results. Individuals from BRCA1/2 and HNPCC mutation families did not differ with regard to their risk perceptions over time. Individuals from BRCA1/2 families perceived hereditary cancer as being more serious. Grover et al. (2009) examined colorectal cancer risk perception among individuals tested for mismatch repair genes mutation and identified factors associated with an appropriate interpretation of their cancer risk. In this study, in particular, the authors paid attention to individuals with an indeterminate genetic test result. Pathogenic mutations in *MLH1* and *MSH2* have been identified in only 30% to 64% of families who meet the clinical criteria for HNPCC and have undergone testing. Genetic testing may not yield a definitive result because of the lack of an identifiable mutation in one of the known genes or a mutation of unclear pathogenic significance. In the absence of an identified family mutation, these results are considered indeterminate or uninformative. Patients remain at an increased risk for colorectal cancer, and intensive cancer screening recommendations are made based on their personal and family cancer histories. A total of 159 individuals who met the Revised Bethesda Guidelines and had previously undergone genetic testing participated in this study.  However, only 62% of individuals with an indeterminate genetic test result

remaining 67% either underestimated or overestimated their risk.

examining the impact of genetic testing for hereditary colorectal tumors have been performed.

In this article, the psychological consequences related to HNPCC are reviewed with regard to the following four points: (1) attitude toward genetic testing, (2) risk perception, (3) psychosocial effects of genetic counseling, and (4) psychosocial aspects after undergoing genetic testing and being informed of the test results. I have reviewed and selected nearly all the articles regarding these themes using the PubMed database.

#### **2. Attitude toward genetic testing**

Many subjects who undergo genetic counseling for HNPCC also wish to undergo genetic testing. However, some subjects refuse to undergo genetic testing, despite its potential benefits. Some previous studies investigated the relationships between the intention to undergo genetic testing and psychosocial variables.

Hadley et al. (2003) investigated attitudes, intention, and the completion of genetic testing among 111 newly identified family members (first-degree relatives) of individuals with HNPCC. Most (97%) stated their intention to pursue testing. Fifty-one percent reported that learning about their children's risks was the most important reason to consider testing. The participants' intentions to pursue genetic testing were significantly affected by concerns regarding their ability to handle the emotional aspects of testing and the psychosocial effect on family members. On the other hand, 39% identified the potential effect on their health insurance as the most important reason not to undergo testing.

Wakefield et al. (2007a) qualitatively assessed 22 individuals' attitudes toward genetic testing for HNPCC. The most frequently reported pros were "to help manage my risk of developing cancer", "to help my family", and "to know my cancer risk." The participants expressed concern about the potential psychological impact of genetic testing. The authors also found that some affected individuals may not fully comprehend the meaning of their potential test results.

Wakefield et al. (2008) conducted a randomized trial to measure the effectiveness of a tailored decision aid designed specifically to assist individuals to make informed decisions regarding genetic testing for HNPCC. The decision aid explains the evidence available regarding HNPCC-related cancer risks, the differences between a mutation search and predictive testing, and the potential benefits, risks, and limitations of testing (Wakefield et al., 2007b). One hundred and fifty-three individuals were randomly assigned to a group who received the decision aid or a group who received a control pamphlet. Evaluations were conducted 1 week after consultation and 6 months after the completion of the intervention using a questionnaire, and 95 subjects completed the 6-month follow-up questionnaire. Although the decision aid had no significant effect on the actual genetic testing decision, the participants who received the decision aid had significantly lower levels of decisional conflict regarding genetic testing and were more likely to be classified as having made an informed choice concerning genetic testing than participants who received a control pamphlet. Furthermore, men who received the decision aid had significantly higher knowledge levels regarding genetic testing than men who received a control pamphlet.

These reports suggest that most individuals pursue genetic testing to help manage their own risk of developing cancer and to learn about their children's risks. On the other hand, however, concerns about psychological and psychosocial issues may present barriers to undergoing genetic testing. The development of patient education tools, such as the decision aid, is needed.

#### **3. Risk perception**

88 Colorectal Cancer – From Prevention to Patient Care

examining the impact of genetic testing for hereditary colorectal tumors have been

In this article, the psychological consequences related to HNPCC are reviewed with regard to the following four points: (1) attitude toward genetic testing, (2) risk perception, (3) psychosocial effects of genetic counseling, and (4) psychosocial aspects after undergoing genetic testing and being informed of the test results. I have reviewed and selected nearly all

Many subjects who undergo genetic counseling for HNPCC also wish to undergo genetic testing. However, some subjects refuse to undergo genetic testing, despite its potential benefits. Some previous studies investigated the relationships between the intention to

Hadley et al. (2003) investigated attitudes, intention, and the completion of genetic testing among 111 newly identified family members (first-degree relatives) of individuals with HNPCC. Most (97%) stated their intention to pursue testing. Fifty-one percent reported that learning about their children's risks was the most important reason to consider testing. The participants' intentions to pursue genetic testing were significantly affected by concerns regarding their ability to handle the emotional aspects of testing and the psychosocial effect on family members. On the other hand, 39% identified the potential effect on their health

Wakefield et al. (2007a) qualitatively assessed 22 individuals' attitudes toward genetic testing for HNPCC. The most frequently reported pros were "to help manage my risk of developing cancer", "to help my family", and "to know my cancer risk." The participants expressed concern about the potential psychological impact of genetic testing. The authors also found that some affected individuals may not fully comprehend the meaning of their

Wakefield et al. (2008) conducted a randomized trial to measure the effectiveness of a tailored decision aid designed specifically to assist individuals to make informed decisions regarding genetic testing for HNPCC. The decision aid explains the evidence available regarding HNPCC-related cancer risks, the differences between a mutation search and predictive testing, and the potential benefits, risks, and limitations of testing (Wakefield et al., 2007b). One hundred and fifty-three individuals were randomly assigned to a group who received the decision aid or a group who received a control pamphlet. Evaluations were conducted 1 week after consultation and 6 months after the completion of the intervention using a questionnaire, and 95 subjects completed the 6-month follow-up questionnaire. Although the decision aid had no significant effect on the actual genetic testing decision, the participants who received the decision aid had significantly lower levels of decisional conflict regarding genetic testing and were more likely to be classified as having made an informed choice concerning genetic testing than participants who received a control pamphlet. Furthermore, men who received the decision aid had significantly higher knowledge levels regarding genetic testing than men who received a control

These reports suggest that most individuals pursue genetic testing to help manage their own risk of developing cancer and to learn about their children's risks. On the other hand,

the articles regarding these themes using the PubMed database.

insurance as the most important reason not to undergo testing.

**2. Attitude toward genetic testing**

undergo genetic testing and psychosocial variables.

performed.

potential test results.

pamphlet.

HNPCC mutation carriers have a life-time risk of colorectal cancer of about 80%, while female carriers have a 40-60% risk of endometrial cancer and a 10-15% risk of ovarian cancer. Communicating cancer risk and assessing the perceived risk is very important for genetic counseling because of subsequent cancer prevention behavior or cancer-related distress. Four reports were extracted regarding risk perception among individuals at risk for HNPCC.

Codori et al. (2005) assessed the effect of genetic counseling on perceived lifetime risk and cancer-distress among 101 adult first-degree-relatives of colorectal cancer patients from families with known or suspected HNPCC. Most persons overestimated their cancer risk, and a higher perceived risk was associated with believing that colorectal cancer cannot be prevented. The individual perceived risk changed after counseling, although the mean perceived risk was unchanged.

Domanska et al. (2007) investigated the perceived cancer risk among 47 HNPCC mutation carriers and correlated the findings with individual characteristics. A perceived risk of colorectal cancer above 60% was reported by 49% individuals, and only one reported a perceived risk > 80%. Female mutation carriers, individuals under the age of 50 years, and individuals who received their counseling within 1 year prior to the study reported a higher perceived risk of colorectal cancer. Individuals who had lost a parent to HNPCC-related cancer at an early age also reported a higher perceived risk. Regarding gynecological cancer, 33% of the women reported a perceived risk of 40-60% for endometrial cancer, whereas the remaining 67% either underestimated or overestimated their risk.

van Oostrom et al. (2007) studied the difference in cancer risk perception among 271 individuals who opted for genetic cancer susceptibility testing for a known familial BRCA1/2 or HNPCC related germline mutation. The assessment was conducted before, 1 week after, and 6 months after disclosure of the test results. Individuals from BRCA1/2 and HNPCC mutation families did not differ with regard to their risk perceptions over time. Individuals from BRCA1/2 families perceived hereditary cancer as being more serious.

Grover et al. (2009) examined colorectal cancer risk perception among individuals tested for mismatch repair genes mutation and identified factors associated with an appropriate interpretation of their cancer risk. In this study, in particular, the authors paid attention to individuals with an indeterminate genetic test result. Pathogenic mutations in *MLH1* and *MSH2* have been identified in only 30% to 64% of families who meet the clinical criteria for HNPCC and have undergone testing. Genetic testing may not yield a definitive result because of the lack of an identifiable mutation in one of the known genes or a mutation of unclear pathogenic significance. In the absence of an identified family mutation, these results are considered indeterminate or uninformative. Patients remain at an increased risk for colorectal cancer, and intensive cancer screening recommendations are made based on their personal and family cancer histories. A total of 159 individuals who met the Revised Bethesda Guidelines and had previously undergone genetic testing participated in this study.  However, only 62% of individuals with an indeterminate genetic test result

Psychological Impact and Associated Factors After Disclosure of

experienced increased worry and physical symptoms after counseling.

insurance, choice or change of jobs, and obtaining a mortgage.

Event Scale) with a correct classification of 86%.

accumulation is needed.

Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer 91

with those for patients with cancer. A substantial minority, however, said that they

Bleiker et al. (2007) examined: 1) levels of cancer-specific distress more than one year after genetic counseling for HNPCC; 2) associations between sociodemographic, clinical and psychosocial factors and levels of distress; 3) the impact of genetic counseling on family relationships; and 4) the social consequences of genetic counseling. One hundred and sixteen individuals who participated in this study completed a self-report questionnaire by mail an average of 4 years after the last counseling session. Among all the subjects, 6% had clinically significant levels of cancer-specific distress (Impact of Event Scale). Having had contact with a professional psychosocial worker for cancer risk in the past 10 years was significantly associated with higher levels of current cancer specific distress. Only a minority of the subjects reported any adverse effects of genetic counseling on communication regarding genetic counseling with their children, family relationships, obtaining life

Keller et al. (2008) conducted a prospective study that examined the impact of multidisciplinary risk counseling on the psychosocial outcome of 139 affected cancer patients and 233 family members without cancer but at risk for HNPCC. Participants completed questionnaires specific to HNPCC before and 8 weeks after attending the cancer clinic. The levels of distress among affected patients exceeded those of unaffected individuals, as did worry regarding their relatives' risk. A significant reduction in general anxiety (Hospital Anxiety and Depression Scale), distress specific to familial colorectal cancer (Impact of Events Scale), and general cancer worry (Distress due to Hereditary Disorder) was demonstrated after counseling among both the affected patients and unaffected individuals. The reduction in distress was more pronounced among affected

patients given a high risk of HNPCC than among those with an intermediate risk.

Hasenbring et al. (2011) prospectively examined the impact of an initial interdisciplinary genetic counseling on feelings of anxiety with a special focus on subgroups related to personal cancer history, sex, age, and education. A significant interaction between time, sex, and age was identified for change in anxiety. While women in general and men older than 50 years revealed a significant reduction in anxiety, younger men did not show any change over time. A logistic regression analysis indicated that clinical Hospital Anxiety and Depression Scale-A cases could be predicted based on general distress (Brief Symptom Inventory) as well as by HNPCC-related cognitions of intrusion and avoidance (Impact of

These studies indicate that anxiety and cancer-specific distress are reduced after genetic counseling, suggesting an overall beneficial impact of comprehensive counseling. On the other hand, a minority of individuals, such as cancer-affected younger men, exhibited adverse effects of genetic counseling on psychosocial variables. Thus, healthcare providers (genetic counselors, human geneticists, oncologists, and psycho-oncologists) should always be aware of psychosocial issues after genetic counseling. However, as little data is available on the psychosocial effects of genetic counseling regarding HNPCC, further data

Since 1991, when a gene for hereditary cancer was first identified, studies expressing concern about the psychosocial aspects of gene diagnosis began in Western countries, with

**5. Psychosocial aspects after being informed of genetic test results**

correctly estimated their risk. Individuals with a history of HNPCC-associated cancer or indeterminate genetic test results were significantly less likely to estimate their cancer risk as being increased.

These reports suggest that despite educational efforts and an increasing amount of data on the risk of cancer associated with HNPCC, few individuals report a perceived risk that is actually correct. In particular, individuals at risk for HNPCC who receive an indeterminate genetic test result may be falsely reassured. It is important that health care providers continue to device a counseling approach for promoting a correct understanding of cancer risk and for discussing the implications of uninformative results on the lifetime cancer risk.

#### **4. Psychosocial effects of genetic counseling**

Cancer genetic counseling has become popular as a result of the recent development of genetic tests that pinpoint familial cancer risk. Such counseling is composed of presymptomatic risk assessment and management (cancer risk counseling) and reproductive risk counseling. The former has two components: risk assessment and counseling regarding behavioral, medical, and surgical options to decrease risk. A basic goal of cancer risk counseling is to derive and explain an individual's cancer risk in clear terms, and the counselor's role is to educate and enumerate options for patients and clinicians, answer questions regarding what is known, and suggest appropriate referrals to help individuals reach difficult decisions.

A cancer risk counseling session is comprised of the following components: 1) baseline risk perception; 2) medical history and exposure history; 3) pedigree construction and pedigree documentation; 4) empiric risk assessment and genetic risk assessment; 5) options for early detection and prevention; 6) options, risks, and benefits of genetic testing; and 7) response to questions, support, and plans for follow-up. Throughout these discussions, a sensitivity to the psychological and ethical aspects of counseling is essential. Therefore, continued followup by the counselor after the session is the best way to limit the potential for adverse effects as a result of the knowledge of an inherited cancer risk, and ready access to liaison mental health professionals with experience in cancer genetics is thought to be a valued asset of cancer risk counseling.

Psychological research on aspects of cancer genetic counseling has focused on three broad areas: factors predicting interest in cancer genetic testing (Lerman et al., 1996), the psychological impact and effect of genetic counseling and testing for inherited cancer risk (Lerman et al., 1997), and the relationship between psychological distress and preventive behaviors (Kash et al., 1992). In each of these areas, the results have implications for the management of at-risk individuals. However, such data is unlikely to be applicable to every case because of cultural differences among study populations and the complexity of the instruments used in research studies, in addition to the fact that most of these studies have been performed for hereditary breast cancer. In this section, four studies on the psychological impacts of genetic counseling regarding HNPCC are reviewed.

Keller et al. (2002) explored distress before and after comprehensive interdisciplinary counseling in families at risk for HNPCC. Sixty-five individuals (31 patients with colorectal cancer and 34 unaffected at-risk persons) participated in this study. Data were collected from semi-structured questionnaires before, as well as 4-6 weeks after counseling. Distress declined after counseling, as did worries related to HNPCC. A trend toward a greater anticipated ability to cope with a positive gene test was also observed after counseling. Changes after counseling were generally more pronounced for persons at risk, compared

correctly estimated their risk. Individuals with a history of HNPCC-associated cancer or indeterminate genetic test results were significantly less likely to estimate their cancer risk

These reports suggest that despite educational efforts and an increasing amount of data on the risk of cancer associated with HNPCC, few individuals report a perceived risk that is actually correct. In particular, individuals at risk for HNPCC who receive an indeterminate genetic test result may be falsely reassured. It is important that health care providers continue to device a counseling approach for promoting a correct understanding of cancer risk and for discussing the implications of uninformative results on the lifetime cancer risk.

Cancer genetic counseling has become popular as a result of the recent development of genetic tests that pinpoint familial cancer risk. Such counseling is composed of presymptomatic risk assessment and management (cancer risk counseling) and reproductive risk counseling. The former has two components: risk assessment and counseling regarding behavioral, medical, and surgical options to decrease risk. A basic goal of cancer risk counseling is to derive and explain an individual's cancer risk in clear terms, and the counselor's role is to educate and enumerate options for patients and clinicians, answer questions regarding what is known, and suggest appropriate referrals to help

A cancer risk counseling session is comprised of the following components: 1) baseline risk perception; 2) medical history and exposure history; 3) pedigree construction and pedigree documentation; 4) empiric risk assessment and genetic risk assessment; 5) options for early detection and prevention; 6) options, risks, and benefits of genetic testing; and 7) response to questions, support, and plans for follow-up. Throughout these discussions, a sensitivity to the psychological and ethical aspects of counseling is essential. Therefore, continued followup by the counselor after the session is the best way to limit the potential for adverse effects as a result of the knowledge of an inherited cancer risk, and ready access to liaison mental health professionals with experience in cancer genetics is thought to be a valued asset of

Psychological research on aspects of cancer genetic counseling has focused on three broad areas: factors predicting interest in cancer genetic testing (Lerman et al., 1996), the psychological impact and effect of genetic counseling and testing for inherited cancer risk (Lerman et al., 1997), and the relationship between psychological distress and preventive behaviors (Kash et al., 1992). In each of these areas, the results have implications for the management of at-risk individuals. However, such data is unlikely to be applicable to every case because of cultural differences among study populations and the complexity of the instruments used in research studies, in addition to the fact that most of these studies have been performed for hereditary breast cancer. In this section, four studies on the

Keller et al. (2002) explored distress before and after comprehensive interdisciplinary counseling in families at risk for HNPCC. Sixty-five individuals (31 patients with colorectal cancer and 34 unaffected at-risk persons) participated in this study. Data were collected from semi-structured questionnaires before, as well as 4-6 weeks after counseling. Distress declined after counseling, as did worries related to HNPCC. A trend toward a greater anticipated ability to cope with a positive gene test was also observed after counseling. Changes after counseling were generally more pronounced for persons at risk, compared

psychological impacts of genetic counseling regarding HNPCC are reviewed.

as being increased.

**4. Psychosocial effects of genetic counseling**

individuals reach difficult decisions.

cancer risk counseling.

with those for patients with cancer. A substantial minority, however, said that they experienced increased worry and physical symptoms after counseling.

Bleiker et al. (2007) examined: 1) levels of cancer-specific distress more than one year after genetic counseling for HNPCC; 2) associations between sociodemographic, clinical and psychosocial factors and levels of distress; 3) the impact of genetic counseling on family relationships; and 4) the social consequences of genetic counseling. One hundred and sixteen individuals who participated in this study completed a self-report questionnaire by mail an average of 4 years after the last counseling session. Among all the subjects, 6% had clinically significant levels of cancer-specific distress (Impact of Event Scale). Having had contact with a professional psychosocial worker for cancer risk in the past 10 years was significantly associated with higher levels of current cancer specific distress. Only a minority of the subjects reported any adverse effects of genetic counseling on communication regarding genetic counseling with their children, family relationships, obtaining life insurance, choice or change of jobs, and obtaining a mortgage.

Keller et al. (2008) conducted a prospective study that examined the impact of multidisciplinary risk counseling on the psychosocial outcome of 139 affected cancer patients and 233 family members without cancer but at risk for HNPCC. Participants completed questionnaires specific to HNPCC before and 8 weeks after attending the cancer clinic. The levels of distress among affected patients exceeded those of unaffected individuals, as did worry regarding their relatives' risk. A significant reduction in general anxiety (Hospital Anxiety and Depression Scale), distress specific to familial colorectal cancer (Impact of Events Scale), and general cancer worry (Distress due to Hereditary Disorder) was demonstrated after counseling among both the affected patients and unaffected individuals. The reduction in distress was more pronounced among affected patients given a high risk of HNPCC than among those with an intermediate risk.

Hasenbring et al. (2011) prospectively examined the impact of an initial interdisciplinary genetic counseling on feelings of anxiety with a special focus on subgroups related to personal cancer history, sex, age, and education. A significant interaction between time, sex, and age was identified for change in anxiety. While women in general and men older than 50 years revealed a significant reduction in anxiety, younger men did not show any change over time. A logistic regression analysis indicated that clinical Hospital Anxiety and Depression Scale-A cases could be predicted based on general distress (Brief Symptom Inventory) as well as by HNPCC-related cognitions of intrusion and avoidance (Impact of Event Scale) with a correct classification of 86%.

These studies indicate that anxiety and cancer-specific distress are reduced after genetic counseling, suggesting an overall beneficial impact of comprehensive counseling. On the other hand, a minority of individuals, such as cancer-affected younger men, exhibited adverse effects of genetic counseling on psychosocial variables. Thus, healthcare providers (genetic counselors, human geneticists, oncologists, and psycho-oncologists) should always be aware of psychosocial issues after genetic counseling. However, as little data is available on the psychosocial effects of genetic counseling regarding HNPCC, further data accumulation is needed.

#### **5. Psychosocial aspects after being informed of genetic test results**

Since 1991, when a gene for hereditary cancer was first identified, studies expressing concern about the psychosocial aspects of gene diagnosis began in Western countries, with

Psychological Impact and Associated Factors After Disclosure of

Table 1. (continued)

Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer 93

the results starting to be reported in 1993. Although studies investigating psychosocial aspects after the subjects had undergone actual genetic testing and had been informed of the test results have been reported, many of these studies have concerned hereditary breast and ovarian cancer, and only a few studies have been performed for HNPCC. Furthermore, little is known about the factors associated with psychosocial aspects. However, HNPCC testing might offer more benefit than hereditary breast and ovarian cancer testing because of the differences in the risk management options available to mutation carriers. In HNPCC, a colonoscopy every 1–2 years is more effective for detecting and preventing adverse health outcomes than measures available to carriers of hereditary breast and ovarian cancer mutations. Therefore, identifying the psychosocial situations in which individuals at risk for colorectal cancer have lived after the disclosure of genetic information or the way in which healthcare providers are able to support the mental states of these individuals are important.

Ten original articles (review articles were not included) assessing psychosocial aspects after individuals had been informed of genetic test results regarding HNPCC were extracted. In this chapter, cross-sectional studies that assessed psychosocial aspects at one time point after disclosure and prospective studies that followed-up psychosocial aspects for 1 year or longer after disclosure are described separately. A summary is shown in Table 1.

#### **5.1 Cross-sectional studies assessing psychosocial aspects after the subjects had been informed of the test results**

Four articles were extracted. Esplen et al. (2001) investigated psychosocial function in 50 individuals who were engaged in the genetic test process for HNPCC (the period between the psychosocial assessment and the disclosure of the test results was 1 – 48 months). Twenty-three individuals were identified as carriers (13 had a previous history of CRC), seven were non-carriers and 20 individuals were still awaiting their test results. The psychosocial scores demonstrated that a subgroup of individuals exhibited distress, with greater distress for those individuals awaiting results or testing positive. A high level of satisfaction was associated with the experience of testing.

Claes et al. (2004) assessed the short-term impact (1month after test result disclosure) of genetic testing using a semi-structured interview and self-reported questionnaires. The subjects were 40 cancer-unaffected relatives who had undergone predictive testing for HNPCC. Distress was within the normal ranges. Distress decreased significantly from preto post-test in non-carriers but not in carriers.

Murakami et al. (2004) identified the prevalence rates and predictors of psychological distress and evaluated the feelings of guilt at one month after the disclosure of test results in Japanese probands and unaffected relatives. The prevalence of major and minor depression, acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and posttraumatic stress symptoms (PTSS) were assessed using the Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders, 3rd edition revised (DSM-III-R) or the DSM-IV; feelings of guilt were investigated using a numeric scale and a semi-structured interview. Forty-two participants completed the 1-month follow-up interview. Although none of the participants met the criteria for major depression, ASD, or PTSD at the time of the follow-up interview, 7% of the participants met the criteria for minor depression and 5% had PTSS. The only predictor of psychological distress was the presence of a history of major or minor depression. Twelve percent of the participants had feelings of guilt.

Table 1. (continued)

92 Colorectal Cancer – From Prevention to Patient Care

the results starting to be reported in 1993. Although studies investigating psychosocial aspects after the subjects had undergone actual genetic testing and had been informed of the test results have been reported, many of these studies have concerned hereditary breast and ovarian cancer, and only a few studies have been performed for HNPCC. Furthermore, little is known about the factors associated with psychosocial aspects. However, HNPCC testing might offer more benefit than hereditary breast and ovarian cancer testing because of the differences in the risk management options available to mutation carriers. In HNPCC, a colonoscopy every 1–2 years is more effective for detecting and preventing adverse health outcomes than measures available to carriers of hereditary breast and ovarian cancer mutations. Therefore, identifying the psychosocial situations in which individuals at risk for colorectal cancer have lived after the disclosure of genetic information or the way in which healthcare providers are able to support the mental states of these individuals are

Ten original articles (review articles were not included) assessing psychosocial aspects after individuals had been informed of genetic test results regarding HNPCC were extracted. In this chapter, cross-sectional studies that assessed psychosocial aspects at one time point after disclosure and prospective studies that followed-up psychosocial aspects for 1 year or

longer after disclosure are described separately. A summary is shown in Table 1.

**5.1 Cross-sectional studies assessing psychosocial aspects after the subjects had**

Four articles were extracted. Esplen et al. (2001) investigated psychosocial function in 50 individuals who were engaged in the genetic test process for HNPCC (the period between the psychosocial assessment and the disclosure of the test results was 1 – 48 months). Twenty-three individuals were identified as carriers (13 had a previous history of CRC), seven were non-carriers and 20 individuals were still awaiting their test results. The psychosocial scores demonstrated that a subgroup of individuals exhibited distress, with greater distress for those individuals awaiting results or testing positive. A high level of

Claes et al. (2004) assessed the short-term impact (1month after test result disclosure) of genetic testing using a semi-structured interview and self-reported questionnaires. The subjects were 40 cancer-unaffected relatives who had undergone predictive testing for HNPCC. Distress was within the normal ranges. Distress decreased significantly from pre-

Murakami et al. (2004) identified the prevalence rates and predictors of psychological distress and evaluated the feelings of guilt at one month after the disclosure of test results in Japanese probands and unaffected relatives. The prevalence of major and minor depression, acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and posttraumatic stress symptoms (PTSS) were assessed using the Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders, 3rd edition revised (DSM-III-R) or the DSM-IV; feelings of guilt were investigated using a numeric scale and a semi-structured interview. Forty-two participants completed the 1-month follow-up interview. Although none of the participants met the criteria for major depression, ASD, or PTSD at the time of the follow-up interview, 7% of the participants met the criteria for minor depression and 5% had PTSS. The only predictor of psychological distress was the presence of a history of

major or minor depression. Twelve percent of the participants had feelings of guilt.

important.

**been informed of the test results**

satisfaction was associated with the experience of testing.

to post-test in non-carriers but not in carriers.

Table 1. (continued)

Psychological Impact and Associated Factors After Disclosure of

Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer 95

CES-D: Center for Epidemiological Studies-Depression, IES: Impact of Event Scale (IES-R: Impact of

ASD: acute stress disorder, PTSD: post-traumatic stress disorder, PTSS: post-traumatic stress symptoms Table 1. Characteristics of studies on psychosocial aspects and associated factors after being

QLI: Quality of Life Index, SCL-90: Symptom Checklist, STAI: State-Trait Anxiety Inventory

Event Scale-Revised), HADS: Hospital Anxiety and Depression Scale,

informed of genetic test results regarding HNPCC

CES-D: Center for Epidemiological Studies-Depression, IES: Impact of Event Scale (IES-R: Impact of Event Scale-Revised), HADS: Hospital Anxiety and Depression Scale,

QLI: Quality of Life Index, SCL-90: Symptom Checklist, STAI: State-Trait Anxiety Inventory ASD: acute stress disorder, PTSD: post-traumatic stress disorder, PTSS: post-traumatic stress symptoms

Table 1. Characteristics of studies on psychosocial aspects and associated factors after being informed of genetic test results regarding HNPCC

94 Colorectal Cancer – From Prevention to Patient Care

Table 1. (continued)

Psychological Impact and Associated Factors After Disclosure of

and long-term increases in distress.

cancer-related distress and state anxiety.

years, were similar to the baseline scores.

positive results.

**5.3 Summary**

life, or lower social support.

Genetic Test Results Concerning Hereditary Nonpolyposis Colorectal Cancer 97

the same time period. Affected and unaffected carriers had higher mean test-specific distress scores at 2 weeks after test result disclosure, compared with non-carriers, in their respective groups; the scores decreased for affected carriers and all unaffected participants from 2 weeks to 12 months after test result disclosure. Higher levels of baseline mood disturbance, a lower quality of life, and lower social support were associated with a risk for both short-

Claes et al. (2005) evaluated distress one year after the disclosure of a predictive genetic test result for HNPCC in 72 cancer-unaffected relatives (36 carriers and 36 non-carriers). The mean levels of distress (cancer-specific distress, state anxiety, and psychoneuroticism) were within the normal ranges and none of the participants had an overall pattern (on all scales) of clinically elevated levels of distress. Carriers had significantly higher cancer-related distress one year after test result disclosure than non-carriers. In both groups, colorectal cancer-related distress decreased. Non-carriers additionally showed decreased endometrial

Collins et al. (2007) conducted a 3-year study of individuals who received predictive genetic test results for previously identified familial mutations regarding HNPCC. Questionnaires were sent before attendance and 2 weeks, 4 months, 1 year, and 3 years after receiving the test results. Psychological measures were included each time. The study included 73 individuals with no personal cancer history (19 carriers and 54 non-carriers). The results showed an increase in mean cancer-specific distress in carriers at 2 weeks with a return to baseline levels by 12 months. This level was maintained until 3 years. Non-carriers showed sustained decreases after testing with a significantly lower level at 3 years compared with at baseline. These scores tended to be lower than those for carriers at 3 years. The mean depression and anxiety scores did not differ between carriers and non-carriers and, at 3

Shiloh et al. (2008) assessed the emotional effects of genetic testing for HNPCC at baseline before testing and again at 6 and 12 months after testing. The subjects were 253 canceraffected and -unaffected individuals. Negative emotional reactions were evaluated using the Revised Impact of Event Scale and the Center for Epidemiological Studies-Depression Scale. Monitoring coping style was assessed at baseline using the Miller Behavioral Style Scale. Mean reductions were indicated in distress and depression levels within the first 6 months after testing. High monitors (individuals who vigilantly attended to threatening cues in their environment in an attempt to emotionally process the situation and who actively engaged in information seeking and cognitive problem solving with the intention of taking precautions) were generally more distressed than low monitors, specifically if they had indeterminate or

Many studies have shown that genetic testing does not result in short- or long-term significant adverse psychological outcomes, including depression, anxiety, and posttraumatic stress disorder (PTSD), in either carriers or non-carriers or in either canceraffected or cancer–unaffected individuals. However, healthcare providers should assess psychological responses, such as minor depression, posttraumatic stress symptoms (PTSS), and feelings of guilt, particularly in individuals who have a history of major or minor depression, nervous personality tendencies, baseline mood disturbances, a lower quality of

Lastly, two cases that showed adverse psychological reactions after being informed of genetic test results will be presented. The first case is a man who was diagnosed as having

Yamashita et al. (2008) elucidated the psychological impact at one month after the disclosure of genetic test results regarding HNPCC and assessed the associated factors, focusing on memory function in particular. The subjects were persons who were suspected of having HNPCC and had been given the choice of undergoing genetic testing. The post-genetic testing psychological impact was evaluated using the Impact of Event Scale-Revised (IES-R), and personality tendencies and memory function were evaluated. Final data were obtained from 46 Japanese probands and unaffected relatives (mutation-positive in 18 subjects, uninformative in 18 subjects, and mutation-negative in 10 subjects). A comparison of the IES-R scores showed that they tended to be higher in the mutation-positive group, but the differences were not statistically significant. The personality tendency "nervousness" and the verbal memory assessed prior to disclosure were significantly associated with the total IES-R score.

#### **5.2 Prospective studies assessing psychosocial aspects after the subjects had been informed of the test results**

Six articles were extracted. Aktan-Collan et al. (2001) assessed general anxiety, fear of cancer and death, satisfaction with life, and attitude regarding the future using a questionnaire survey in 271 individuals with no personal cancer history who were tested for HNPCC. Measurements were made before the first counseling (baseline), at the test disclosure session, and 1 and 12 months after disclosure. Although the mutation-positive individuals were more afraid of cancer than those who were mutation negative at every measurement point, the fear of cancer decreased significantly from the baseline until after disclosure in both groups. The mutation-positive subjects were more anxious than their counterparts immediately after the test disclosure, but the differences had disappeared at the follow-up examinations. Regarding the other variables, no differences among the groups defined according to mutation status or changes over time were detected.

Meiser et al. (2004) assessed the psychological impact of predictive genetic testing for HNPCC in 114 individuals with no personal cancer history (32 carriers and 82 non-carriers) using mailed self-administered questionnaires prior to and 2 weeks, 4 months and 12 months after the disclosure of the test results. Compared with the baseline results, carriers showed a significant increase in the mean scores for intrusive and avoidant thoughts regarding colorectal cancer at 2 weeks after test result disclosure and a significant decrease in the mean depression scores at 2 weeks and 4 months after test result disclosure. For noncarriers, significant decreases in the mean scores for intrusive and avoidant thoughts regarding colorectal cancer were observed at all follow-up assessment time points relative to the baseline. Non-carriers also showed significant decreases from the baseline in the mean depression scores at 2 weeks, 4 months and 12 months after test result disclosure. Significant decreases in the mean state anxiety scores from the baseline were also observed for noncarriers at 2 weeks after test result disclosure.

Gritz et al. (2005) examined the impact of HNPCC genetic test results on the psychological outcomes of cancer-affected and -unaffected participants up to 1 year after test result disclosure. A total of 155 persons completed the study measures before HNPCC genetic testing and at 2 weeks and 6 and 12 months after the disclosure of the test results. The mean scores for all the outcome measures remained stable and within the normal limits for canceraffected participants, regardless of the mutation status. Among unaffected carriers of HNPCC-predisposing mutations, the mean depression, state anxiety, and cancer worry scores increased from baseline to 2 weeks after test result disclosure and decreased from 2 weeks to 6 months after test result disclosure. Among unaffected non-carriers, the mean depression and anxiety scores did not differ, but the cancer worry scores decreased during the same time period. Affected and unaffected carriers had higher mean test-specific distress scores at 2 weeks after test result disclosure, compared with non-carriers, in their respective groups; the scores decreased for affected carriers and all unaffected participants from 2 weeks to 12 months after test result disclosure. Higher levels of baseline mood disturbance, a lower quality of life, and lower social support were associated with a risk for both shortand long-term increases in distress.

Claes et al. (2005) evaluated distress one year after the disclosure of a predictive genetic test result for HNPCC in 72 cancer-unaffected relatives (36 carriers and 36 non-carriers). The mean levels of distress (cancer-specific distress, state anxiety, and psychoneuroticism) were within the normal ranges and none of the participants had an overall pattern (on all scales) of clinically elevated levels of distress. Carriers had significantly higher cancer-related distress one year after test result disclosure than non-carriers. In both groups, colorectal cancer-related distress decreased. Non-carriers additionally showed decreased endometrial cancer-related distress and state anxiety.

Collins et al. (2007) conducted a 3-year study of individuals who received predictive genetic test results for previously identified familial mutations regarding HNPCC. Questionnaires were sent before attendance and 2 weeks, 4 months, 1 year, and 3 years after receiving the test results. Psychological measures were included each time. The study included 73 individuals with no personal cancer history (19 carriers and 54 non-carriers). The results showed an increase in mean cancer-specific distress in carriers at 2 weeks with a return to baseline levels by 12 months. This level was maintained until 3 years. Non-carriers showed sustained decreases after testing with a significantly lower level at 3 years compared with at baseline. These scores tended to be lower than those for carriers at 3 years. The mean depression and anxiety scores did not differ between carriers and non-carriers and, at 3 years, were similar to the baseline scores.