Innovative techniques to address retention in a behavioral weight-loss trial. Effect of providing cancer patients with the audiotaped initial consultation on satisfaction, recall, and quality of life: a randomized, double-blind study. Adherence to moderate-intensity exercise during breast cancer therapy. Psychological adjustment and sleep quality in a randomized trial of the effects of a Tibetan yoga intervention in patients with lymphoma Higher magnitude cash payments improve research follow-up rates without increasing drug use or perceived coercion. Going Quasi: The Premature Disclosure Effect in a Randomized Clinical Trial Correlates of adherence and contamination in a randomized controlled trial of exercise in cancer survivors: An application of the theory of planned behavior and the five factor model of personality Outcomes from the Moving Beyond Cancer psychoeducational, randomized, controlled trial with breast cancer patients. Subjects matter: a survey of public opinions about a large genetic cohort study The effect of telephone social support and education on adaptation to breast cancer during the year following diagnosis. Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Evaluation of adjuvant psychological therapy in patients with testicular cancer: randomised controlled trial Cognitive-existential group psychotherapy for women with primary breast cancer: a randomised controlled trial. Managing menopausal symptoms in breast cancer survivors: results of a randomized controlled trial. Patient/Caregiver influences for declining participation in supportive oncology trials. Facilitation of self-transcendence in a breast cancer support group: II. Is the wish to participate in a cancer rehabilitation program an indicator of the need? Comparisons of participants and non-participants in a randomized study. Individual psychological support for cancer patients: utilisation and patient satisfaction. Efficacy of Therapeutic Group by Telephone for Women With Breast Cancer Lessons Learned: Outcomes and Methodology of a Coping Skills Intervention Trial Comparing Individual and Group Formats for Patients with Cancer A presurgical psychosocial intervention for breast cancer patients. psychological distress and the immune response. The effects of guided imagery on comfort of women with early stage breast cancer undergoing radiation therapy. The efficacy of a mind-body-spirit group for women with breast cancer: a randomized controlled trial. A two-stage trial design for testing treatment, self-selection and treatment preference effects. Psychological intervention in cancer patients: a randomized study. Intervention to improve psychological functioning for newly diagnosed patients with cancer. Group psychotherapy for recently diagnosed breast cancer patients: a multicenter feasibility study. The addition of an audiocassette recording of a consultation to written recommendations for patients with advanced cancer In a randomized controlled trial, missing data led to biased results regarding anxiety. Psychosocial intervention for rural women with breast cancer Psychological adjustment among African American breast cancer patients: one-year follow-up results of a randomized psychoeducational group intervention. Effects of advanced nursing care on quality of life and cost outcomes of women diagnosed with breast cancer. Impact of psychotherapeutic support on gastrointestinal cancer patients undergoing surgery: survival results of a trial. Electronic support groups for breast carcinoma A phase II trial of Reiki for the management of pain in advanced cancer patients. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. A randomized psychosocial intervention study on the effect of home visits on the well-being of Danish colorectal cancer patients--the INCA Project. An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers.
Given that retention rates for weight-loss trials have not significantly improved in the past 20 years , identifying effective techniques to enhance retention is critical . This paper describes a conceptual and practical advance that may have improved retention in a behavioral weight-loss trial-the novel application of motivational interviewing techniques to diffuse ambivalence during interactive group-based orientation sessions prior to r and omization . These orientation sessions addressed ambivalence about making eating and exercise behavior changes , ambivalence about joining a r and omized controlled trial , and unrealistic weight-loss expectations . During these sessions , overweight and obese men and women learned about the health benefits of modest weight loss as well as trial design , the importance of a control condition , r and om assignment and the impact of dropouts . Participants were then divided into groups of three or four , and asked to generate two pros and two cons of being assigned to a control condition and an active condition . Participants shared their pros and cons with the larger group , while the investigator asked open-ended questions , engaged in reflective listening and avoided taking a ' pro-change ' position . Retention was high , with 96 % of the participants ( N = 162 ) completing 18-month clinic visits PURPOSE By means of a r and omized double-blind study , the effect of providing taped initial consultations on cancer patients '  satisfaction , recall , and quality of life was investigated . PATIENTS AND METHODS Consecutive cancer patients referred to either the gynecology or medical oncology outpatient clinic were eligible .  Initial consultations were audiotaped . Patients were either provided with the tape ( experimental group ) or not ( control group ) . Baseline variables included sociodemographics , preferences for information , coping styles , and clinical characteristics . Follow-up ( after 1 week and 3 months ) variables included attitudes toward the intervention , satisfaction , recall , and quality of life . Assessment s took place through mailed question naires and telephone interviews . RESULTS Two hundred one patients were included ( response , 71 % ) , 105 in the experimental group and 96 in the control group . Most patients ( 75 % ) listened to the tape , the majority of which ( 73 % ) listened with others . Almost all patients , both in the experimental group ( 96 % ) and control group ( 98 % ) were positive about the intervention . Expectations were confirmed ; patients provided with the tape were more satisfied ( P < .05 ) and recalled more information ( P < .01 ) than patients without the tape . The intervention did not have an effect on quality of life . An interaction effect was found between the intervention and patients ' age on satisfaction with the taped consultation ( P < .01 ) and recall of diagnostic information ( P < .01 ) ; access to tapes seems more helpful in enhancing satisfaction in younger patients and recall of diagnostic information in older patients . CONCLUSION Cancer patients and their families value the taped initial consultation . This intervention enhances their satisfaction and improves their recall of information . Tapes seem more helpful in enhancing satisfaction in younger patients and recall of diagnostic information in older patients PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs . Women who lead sedentary lifestyles may benefit from a structured exercise program that includes information and support related to exercise adherence strategies Research suggests that stress‐reduction programs tailored to the cancer setting help patients cope with the effects of treatment and improve their quality of life .  Yoga , an ancient Eastern science , incorporates stress‐reduction techniques that include regulated breathing , visual imagery , and meditation as well as various postures . The authors examined the effects of the  Tibetan yoga ( TY ) practice s of Tsa lung and Trul khor , which incorporate  controlled breathing and visualization , mindfulness techniques  , and low‐impact postures  in patients with lymphoma In a prior study [ Festinger , D.S. , Marlowe , D.B. , Croft , J.R. , Dugosh , K.L. , Mastro , N.K. , Lee , P.A. , DeMatteo , D.S. , Patapis , N.S. , 2005 . Do research payments precipitate drug use or coerce participation ? Drug Alcohol Depend . 78 ( 3 ) 275 - 281 ] we found that neither the mode ( cash vs. gift card ) nor magnitude ( $ 10 , $ 40 , or $ 70 ) of research follow-up payments increased rates of new drug use or perceptions of coercion . However , higher payments and payments in cash were associated with better follow-up attendance , reduced tracking efforts , and improved participant satisfaction with the study . The present study extended those findings to higher payment magnitudes . Participants from an urban outpatient substance abuse treatment program were r and omly assigned to receive $ 70 , $ 100 , $ 130 , or $ 160 in either cash or a gift card for completing a follow-up assessment at 6 months post-admission ( n congruent with 50 per cell ) . Apart from the payment incentives , all participants received a st and ardized , minimal platform of follow-up efforts . Findings revealed that neither the magnitude nor mode of payment had a significant effect on new drug use or perceived coercion . Consistent with our previous findings , higher payments and cash payments result ed in significantly higher follow-up rates and fewer tracking calls . In addition participants receiving cash vs. gift cards were more likely to use their payments for essential , non-luxury purchases . Follow-up rates for participants receiving cash payments of $ 100 , $ 130 , and $ 160 approached or exceeded the FDA required minimum of 70 % for studies to be considered in evaluations of new medications . This suggests that the use of higher magnitude payments and cash payments may be effective strategies for obtaining more representative follow-up sample s without increasing new drug use or perceptions of coercion This paper describes a r and omized clinical trial investigating a stress management program for women with breast cancer , which inadvertently turned quasi-experimental . Due to logistical considerations , group assignment was disclosed to participants ( n = 63 ) prior to baseline assessment . Analyses of baseline measures unexpectedly revealed statistically significant differences between groups on psychological functioning . We suggest that what appears to be failed r and omization may in fact point toward an important phenomenon which we have termed premature disclosure effect ( PDE ) . A hierarchical regression model , developed to help explain the PDE , accounted for 47 % of the variance . The findings indicate the importance of considering participant belief , preferences , and attributes when design ing research protocol s and interventions . Potential implication s of PDE for clinical research in behavioral medicine are discussed and specific statistical method ologies suggested In this study , we examined correlates of adherence and contamination in a r and omized controlled trial ( RCT ) of exercise in cancer survivors using the theory of planned behavior and the Five Factor Model of personality ( FFM ) . We r and omly assigned cancer survivors in group psychotherapy classes to either a waiting-list control group ( n = 45 ) or a home-based , moderate intensity exercise program ( n = 51 ) . At baseline , participants completed  measures  of the theory of planned behavior , the FFM , past exercise , physical fitness , medical variables , and demographics . We then monitored exercise over a 10-week period by weekly self-reports . Hierarchical multiple regression analyses indicated that the independent predictors of overall RCT exercise across both conditions were past exercise ( β = .36 , p > .001 ) , assignment to experimental condition ( β = .34 , p > .001 ) , sex ( β = .30 , p > .001 ) , and intention ( β = .14 , p > .10 ) . For exercise adherence in the exercise condition , the independent predictors were sex ( β = .38 , p > .01 ) , extraversion ( β = .30 , p > .05 ) , normative beliefs ( β = -.27 , p > .05 ) , and perceived behavioral control ( β = .23 , p > .10 ) . Finally , the independent predictors of exercise contamination in the control condition were past exercise ( β = .70 , p > .001 ) , sex ( β = .20 , p > .05 ) , and intention ( β = .17 , p > .10 ) . We conclude that the correlates of exercise adherence and contamination differ in kind as well as in degree . Explanations for these findings and practical implication s for conducting exercise RCTs in this population are offered PURPOSE Evidence suggests that the re-entry phase ( ie , early period after medical treatment completion ) presents distinct challenges for cancer patients . To facilitate the transition to recovery , we conducted the Moving Beyond Cancer ( MBC ) trial , a multisite , r and omized , controlled trial of psychoeducational interventions for breast cancer patients . METHODS Breast cancer patients were registered within 6 weeks after surgery . After medical treatment , they completed baseline measures and were r and omly assigned to st and ard National Cancer Institute print material ( CTL ) ; st and ard print material and peer-modeling videotape ( VID ) ; or st and ard print material , videotape , two sessions with a trained cancer educator , and informational workbook ( EDU ) . Two primary end points were examined : energy/fatigue and cancer-specific distress . Secondary end points were depressive symptoms and post-traumatic growth . Perceived preparedness for re-entry was analyzed as a moderator of effects . RESULTS Of 558 women r and omly assigned to treatment , 418 completed the 6-month assessment and 399 completed the 12-month assessment . In analyses controlling for study site and baseline depressive symptoms , VID produced significant improvement in energy/fatigue at 6 months relative to CTL , particularly among women who felt less prepared for re-entry at baseline . No significant main effect of the interventions emerged on cancer-specific distress , but EDU prompted greater reduction in this outcome relative to CTL at 6 months for patients who felt more prepared for re-entry . Between-group differences in the primary outcomes were not significant at 12 months , and no significant effects emerged on the secondary end points . CONCLUSION A peer-modeling videotape can accelerate the recovery of energy during the re-entry phase in women treated for breast cancer , particularly among those who feel less prepared for re-entry Purpose : Cohort studies investigating genes , environment , and lifestyle require large study population s. To recruit and retain participants , it is important to underst and the relative significance of influences on people 's motivation to participate . To this end , 4659 Americans were surveyed about support for and willingness to participate in a proposed large cohort study . Methods : An  online survey of US adults was conducted between December 2007 and January 2008 . To measure the influence of study burden , compensation and receipt of individual research results  on willingness to participate , respondents were r and omized to one of eight different study scenarios . Results : Most respondents ( 84 % ) supported the study , and 60 % would participate . Returning research results ( odds ratio = 1.6 , 95 % confidence interval 1.3–1.8 ) and increasing compensation from $ 50 to $ 200 ( odds ratio = 1.5 , 95 % confidence interval 1.2–1.7 ) were associated with increased willingness to participate . Decreasing study burden was less important ( odds ratio = 1.2 , 95 % confidence interval 1.0–1.4 ) . Three in four respondents would be less likely to participate without the return of research results . Support and willingness varied little among demographic groups ; variation in influences of the three factors on willingness was observed . Conclusion : Widespread support exists in the general public for a large national cohort study . Providing individual research results is a strong motivation to participate ; compensating participants $ 200 may increase participation a similar amount . Incentives , recruitment , and return of results could be tailored to demographics groups ' interests PURPOSE / OBJECTIVES To find the most effective methods of providing social support for women diagnosed with breast cancer by testing the effectiveness of a telephone social support and education intervention to promote emotional and interpersonal adaptation to breast cancer . DESIGN Multisite , two-group experimental study with repeated measures . SETTING Arkansas and New Jersey . SAMPLE The Arkansas sample consisted of 106 women who entered the study two to four weeks postsurgery for nonmetastatic breast cancer and were r and omly assigned to an experimental or control group . The comparison group consisted of 91 women from New Jersey who had participated in a previously completed study that used the same interventions and found that telephone support result ed in more positive , statistically significant adaptation to the disease . METHODS The experimental group received 13 months of telephone social support and education . Both groups received educational material s via a mailed re source kit . The Profile of Mood States ; Visual Analogue Scale-Worry ; Relationship Change Scale ; University of California , Los Angeles , Loneliness Scale-Version 3 ; and the modified Symptom Distress Scale provided data regarding the variables of interest . Data analysis included descriptive statistics , t tests , and multivariate analysis of variance with repeated measures . MAIN RESEARCH VARIABLES Mood , worry , relationships with significant others , loneliness , and symptoms . FINDINGS Data analysis showed no significant differences between groups , and both improved on some of the outcomes . Significant time-by-location interaction effects were found when comparing the Arkansas and New Jersey sample s , thereby supporting the need to consider regional differences when developing interventions . CONCLUSIONS The mailed educational re source kit alone appeared to be as effective as the telephone social support provided by oncology nurses in conjunction with the mailed re source kit . IMPLICATION S FOR NURSING Mailed educational re source kits may be the most efficient and cost-effective way to provide educational support to newly diagnosed patients with breast cancer , but their effect may differ according to region PURPOSE / OBJECTIVES To investigate the feasibility of an exercise program patterned after a phase II cardiac rehabilitation program to improve selected physiologic and psychological parameters of health in patients with cancer . DESIGN Prospect i ve , repeated measures study . SETTING Two major military medical centers in the southwestern United States . SAMPLE 62 patients diagnosed with cancer within the previous two years . Ages ranged from 24 - 83 ( meanX = 59 ) . Half of the participants were male and half were female . Minorities made up 29 % of the sample . Participants had a wide range of cancer diagnoses and all stages of cancer . Fifteen subjects were undergoing treatment when they enrolled in the study . More than half of the subjects exercised prior to their cancer diagnoses , but fewer than half were able to resume an exercise routine following their cancer diagnoses . METHODS Subjects met two days each week for 12 weeks for exercise and education . MAIN RESEARCH VARIABLES Exercise tolerance as measured with a grade d exercise test , activity and sleep patterns as measured with a wrist actigraph , and quality of life ( QOL ) as measured with the Cancer Rehabilitation Evaluation System-Short Form . FINDINGS Significant improvements were observed over time in exercise tolerance , selected activity and sleep patterns , and QOL among the 46 ( 74 % ) subjects who completed the program . CONCLUSIONS Patients with various types and stages of cancer can safely exercise using a cardiac rehabilitation model and can realize significant improvements in exercise tolerance , selected activity and sleep patterns , and QOL . IMPLICATION S FOR NURSING Most people are aware that regular exercise is part of a healthy lifestyle . After cancer diagnosis and treatment , patients experience uncertainty regarding how to resume exercise or how to begin an exercise program as part of their rehabilitation . Participation in a structured exercise program can provide patients with a safe environment within which to exercise at an intensity appropriate to their individual needs Abstract Objective : To determine the efficacy of adjuvant psychological therapy in patients with testicular cancer and to compare the characteristics and psychosocial outcomes of men who agreed to participate with those who declined to participate in a r and omised trial of psychological intervention  . Design : Newly diagnosed patients were asked to participate in a r and omised trial of psychological support compared with st and ard medical care . Participants and non- participants completed self assessment question naires at baseline and at 2 , 4 and 12 months . Setting : Testicular Tumour Unit of the Royal Marsden Hospital . Subjects : 73 of 184 ( 40 % ) eligible patients agreed to enter the r and omised trial ( participants ) and 81 ( 44 % ) declined to participate but agreed to complete further assessment s ( non- participants ) . 30 patients wanted no further contact with the research ers . Outcome measures : Hospital anxiety and depression scale , psychosocial adjustment to illness scale , Rotterdam symptom checklist , mental adjustment to cancer scale . Only scores on the hospital anxiety and depression scale are reported for evaluating treatment efficacy . Results : 111 of 184 ( 60 % ) eligible men declined to participate in the trial . Patients with stage I disease were most likely to refuse to participate . A patient was less likely to participate if he had low volume disease and was receiving no further treatment . Likelihood of participation was associated with stage of disease and with type of primary treatment ( P<0.001 for heterogeneity ) . Patients with early stage disease ( P<0.001 ) and fewer physical symptoms ( P<0.001 ) were less likely to participate . Psychosocial factors associated with participation included anxious preoccupation regarding disease ( P=0.01 ) . There were no differences in outcome between participants and non- participants during follow up . Patients seemed to gain little benefit from adjuvant psychological therapy . At 2 months change from baseline favoured the treated group in the anxiety subscale ( mean difference between groups −1.41 ( 95 % confidence interval −2.86 to 0.03 ) ) . This was not sustained when adjusted for factors related to the disease . By 12 months change from baseline seemed to favour the control group ( mean difference between groups 1.66 ( −0.18 to 3.50 ) ) . Conclusions : Patients with testicular cancer seem to have considerable coping abilities . Those who declined to participate in the trial differed from those who participated . Those who agreed to participate may comprise the clinical group who perceive a need for psychological support . No evidence was found to indicate a need for routinely offering adjuvant psychological therapy . Key messages Counselling for patients with cancer is widely advocated , although its effectiveness has not been fully evaluated No study of patients with cancer has evaluated a psychological intervention in young men or in a group of patients with a disease with an excellent prognosis Most patients with testicular cancer declined to participate in this r and omised trial of adjuvant psychological therapy , and those who participated had more psychosocial dysfunction No evidence of benefit was observed after treatment with adjuvant psychological therapy in this group of patients There were no consistently significant differences in psychosocial outcome over one year between those who agreed to participate and those who declined to BACKGROUND We conducted a r and omised , controlled trial of cognitive-existential group therapy ( CEGT ) for women with early stage breast cancer receiving adjuvant chemotherapy with the aim of improving mood and mental attitude to cancer . METHODS Women were r and omised to 20 sessions of weekly group therapy plus 3 relaxation classes or to a control arm receiving 3 relaxation classes . Assessment s , independently done at baseline , 6 and 12 months , included a structured psychiatric interview and vali date d question naires covering mood , attitudes to cancer , family relationships , and satisfaction with therapy . RESULTS Three hundred and three of 491 ( 62 % ) eligible patients participated over 3 years .  Distress was high pre-intervention : 10 % were diagnosed as suffering from major depression , 27 % from minor depression and 9 % from anxiety disorders . On an intention-to-treat analysis , there was a trend for those receiving group therapy ( n=154 ) to have reduced anxiety ( p=0.05 , 2-sided ) compared to controls ( n=149 ) . Women in group therapy also showed a trend towards improved family functioning compared to controls ( p=0.07 , 2-sided ) . The women in the groups reported greater satisfaction with their therapy ( p<0.001 , 2-sided ) , appreciating the support and citing better coping , self-growth and increased knowledge about cancer and its treatment . They valued the CEGT therapy . Overall effect size for the group intervention was small ( d=0.25 ) , with cancer recurrence having a deleterious effect in three of the 19 therapy groups . Psychologists as a discipline achieved a moderate mean effect size ( d=0.52 ) . CONCLUSION CEGT is a useful adjuvant psychological therapy for women with early stage breast cancer . Interaction effects between group members and therapists are relevant to outcome . Group-as-a-whole effects are powerful , but the training and experience of the therapist is especially critical to an efficacious outcome BACKGROUND Menopausal symptoms ( e.g. , hot flashes , vaginal dryness , and stress urinary incontinence ) are very common in breast cancer survivors and can not be managed with st and ard estrogen replacement therapy ( ERT ) in these patients . The purpose of this study was to test the efficacy of a comprehensive menopausal assessment ( CMA ) intervention program in achieving relief of symptoms , the improvement in quality of life ( QOL ) , and sexual functioning in breast cancer survivors . METHODS Using a two-group , r and omized controlled design , we assigned 76 postmenopausal breast cancer survivors with at least one severe target symptom either to the intervention group or to a usual-care group . Seventy-two women were evaluable at the end of the study period . The CMA intervention , delivered by a nurse practitioner , focused on symptom assessment , education , counseling and , as appropriate , specific pharmacologic and behavioral interventions for each of the three target symptoms . Psychosocial symptoms were assessed with the use of a self-report screening instrument , and distressed women were referred for counseling if needed . The intervention took place over a 4-month period . Outcomes measured were scores on a composite menopausal symptom scale , the R AND Short Form Health Survey Vitality Scale , and the Cancer Rehabilitation Evaluation System ( CARES ) Sexual Functioning Scale at baseline and at 4-month follow-up . All statistical tests were two-sided and were performed at the alpha = . 05 significance level . RESULTS Patients receiving the intervention demonstrated statistically significant improvement ( P = .0004 ) in menopausal symptoms but no significant change in vitality ( P = .77 ) . Sexual functioning was statistically significantly improved ( P = .04 ) in the treatment group compared with the usual-care group . CONCLUSIONS A clinical assessment and intervention program for menopausal symptom management in breast cancer survivors is feasible and acceptable to patients , leading to reduction in symptoms and improvement in sexual functioning . Measurable improvement in a general QOL measure was not demonstrated Enrolling adequate numbers of subjects to research projects that focus on the supportive needs of patients and caregivers is difficult , and this difficulty significantly impedes investigation of this important research area . We report reasons that patients or their informal caregivers declined to participate in one of two r and omized , longitudinal clinical trials testing the Comprehensive Health Enhancement Support System ( CHESS ) , a  Web-based information and support scheme  for people with advanced cancer and their primary informal caregivers . Patients were asked why they declined participation in these trials ; their responses then were recorded and coded into themes . The leading reasons included factors related to using a computer  ( eg , lack of familiarity with using this technology , access to other re sources ) , being attended to by a caregiver ( eg , poor caregiver health , caregiver burden , patient doing well and not needing a caregiver ) , taking part in a study ( eg , survey burden , privacy concerns , wording of the consent form ) , dealing with personal issues ( eg , time commitment , timing of study , feelings of being overwhelmed , and coping styles ) , and lack of interest . By using eligibility criteria that largely parallel those for studies of chemotherapeutic regimens , this research project highlighted reasons why subjects decline participation in clinical trials . This information was specific to supportive care trials ; it may help research ers plan recruitment strategies and enrollment targets PURPOSE / OBJECTIVES To pilot a second support group intervention study promoting self-transcendence perspectives and activities and to document changes over time in well-being in support group participants compared with non participants . DESIGN Quasiexperimental , partial r and omization , preference trial design . SETTING An urban breast cancer re source center established by survivors . SAMPLE 41 women with newly diagnosed breast cancer were recruited , and 39 completed the study . 22 women participated in three intervention support groups ; 17 were in a comparison group . METHODS The intervention was an eight-week , closed support group based on self-transcendence theory . Data were collected three times during 14 months . MAIN RESEARCH VARIABLES Support group intervention , self-transcendence , and emotional and physical well-being . FINDINGS The intervention group had lower scores than the comparison group on self-transcendence and well-being variables at baseline ( time [ T ] 1 ) . Scores were higher for both groups postintervention ( T2 ) , with no differences between groups . One year postintervention ( T3 ) , intervention group scores again were lower than comparison group scores . Intervention group T3 scores were unchanged from T2 . CONCLUSIONS Most potential participants were unwilling to risk being r and omized into a nonpreferred group . Activities based on self-transcendence theory were associated with exp and ed perspectives and activities and an improved sense of well-being in support group participants at the end of the intervention , but not one year later . Findings from the pilot studies informed a study currently in progress . IMPLICATION S FOR NURSING Nurses should maintain awareness of local re sources for support and make that information available to women when they are newly diagnosed with breast cancer , during their treatment , and later In parallel with a r and omized study of the ' starting again ' rehabilitation program for cancer patients , a group of 73 non- participants were monitored ( another 20 patients declined monitoring ) . In comparison with participants ( intervention + control ) , gender , diagnosis , and 10 out of 18 dependent measures differed significantly at baseline . The non- participants group included more men , mostly with cancer of the prostate and irrespective of gender , they showed lower problem levels than participants throughout . Thus , the wish to participate seems to be an indicator of the need for assistance in the rehabilitation process . Social validation of effects was performed by comparing the non- participants with the intervention group . The rationale for this comparison is that non- participants presumably felt so well that they were in no need of rehabilitation . Effects on three variables were socially vali date d : patients ' appraisal of having received sufficient information , physical strength and fighting spirit . No negative effects on outcome variables result ing from being r and omized to the control condition ( resentful demoralization ) were detected when non- participants were compared with controls over one year . Further analysis showed that although a few patients in the control group may have experienced resentful demoralization , this did not significantly affect the outcome variables A short-term , problem-focused Individual Psychological Support ( IPS ) intervention was evaluated . The IPS was one of the interventions in a study where 527 patients newly diagnosed with breast , colorectal , gastric or prostate cancer were r and omised between IPS ( n = 265 ) and a  control condition  ( n = 262 ) . The IPS made use of cognitive-behavioural techniques and aim ed at reducing depression and anxiety , to increase the feeling of mastery of the situation and to facilitate active participation in medical treatments . Half of the patients receiving the IPS had more than 2 sessions . After termination of the IPS , the patients were mailed a question naire concerning satisfaction with and perceived benefit from the IPS . A majority of the responding patients stated that their problems were addressed to a great extent , that the number of contacts was adequate and that the IPS came at the right time . Patients reporting problems received more sessions and perceived more benefits than patients reporting no problems A pilot study was conducted to test the efficacy of a therapeutic group by telephone conference call for women with breast cancer . Sixty-six women with stage I or stage II breast cancer consented to participate in the study . Participants were r and omly assigned to a usual psychosocial care or intervention group , using a permuted block method . Only 2 of 68 patients dropped out of the study , which included 27 % African Americans . Assessment s at 3 time periods ( pretest , immediately after the intervention , and 3 months after the group ended ) included evaluation of quality of life ( QOL ) , mood , and immune function . t tests were performed to determine if differences on important variables existed at pretest . The intervention group had worse QOL and mood scores than did the control group on the pretests . A mixed-model repeated- measures procedure controlling for pretest differences was used to analyze data . A significant Group by Time interaction was found for spiritual well-being and mood . These differences were not in the expected direction . The intervention group showed improvement in QOL and mood during the intervention , but showed decompensation following the intervention . Conversely , the control group demonstrated stable or declining scores . This intervention is feasible and practical for women with breast cancer , especially African American participants . The puzzling results suggest several areas for future research , including a better conceptual fit with outcome measures , increasing dosage , and exploration of the value of emotional expression Objective : Nucare , a short-term psychoeducational coping skills training intervention was evaluated in a r and omized controlled clinical trial ( RCT ) of 225 newly diagnosed breast and colon cancer patients . Method : Measures of psychosocial distress , well being and optimism were evaluated every four months during a one-year period . Patients were r and omized to one of four arms : Nucare presented in an individual basis ; Nucare presented in a group format ; a non-directive supportive group ; and a no-intervention control . The interventions were provided in five sessions of ninety minutes each . Results : Patients with breast cancer who received Nucare  presented in an individual format showed more significant improvements in well-being over time compared to those in the control and group arms . Conclusions : We were unable to develop functioning groups within the RCT . Partial explanations for the latter finding include the structural limitations of the RCT : the groups were small , difficult to schedule and patients indicated that they would have preferred to choose whether or not to participate in a group . The positive changes in women with breast cancer who received Nucare persisted at 12 months OBJECTIVE The present study evaluated the feasibility and potential immunological benefit of a presurgical intervention for breast cancer patients . METHODS Forty-one newly diagnosed breast cancer patients were r and omized into control ( st and ard care ) and intervention groups . In addition to st and ard care , intervention group members received a two-session psychosocial intervention . Blood was drawn at three timepoints : ( 1 ) at preintervention ; ( 2 ) at postintervention/presurgery ; and ( 3 ) at postsurgery . RESULTS Examination of the immunological data revealed evidence of suppression of interferon-gamma ( IFN-gamma ) in the control group over time , but not in the intervention group . Secondary findings related to psychological assessment generally paralleled the IFN-gamma results . CONCLUSION The relevance and applicability of these findings to future breast cancer intervention research is detailed PURPOSE / OBJECTIVES To measure the effectiveness of customized guided imagery for increasing comfort in women with early stage breast cancer . DESIGN Experimental longitudinal , r and om assignment to groups . SETTING Two urban radiation oncology departments . SAMPLE 53 women ( 26 in the experimental group , 27 in the control group ) aged 37 - 81 ; 80 % European and 10 % African American with stage I or II breast cancer about to begin radiation therapy . METHODS The experimental group was to listen to a guided imagery audiotape once a day for the duration of the study . The  Radiation Therapy Comfort Question naire was self-administered at three time points : prior to the introduction of intervention and the beginning of radiation therapy ( Time 1 ) , three weeks later ( Time 2 ) , and three weeks after completing radiation therapy ( Time 3 ) . The  State Anxiety Inventory  was administered at Time 1 only . MAIN RESEARCH VARIABLES The effect of use of guided imagery on comfort with anxiety as a control variable . FINDINGS Pooled data indicated a significant overall increase in differences in comfort between the treatment and control group , with the treatment group having higher comfort over time . The data also revealed a significant linear trend in differences between groups . No significant interaction of group and time existed . CONCLUSIONS Guided imagery is an effective intervention for enhancing comfort of women undergoing radiation therapy for early stage breast cancer . The intervention was especially salient in the first three weeks of therapy . IMPLICATION S FOR NURSING PRACTICE Guided imagery audiotapes specifically design ed for this population were re source effective in terms of cost , personnel , and time Increasing numbers of women with breast cancer are seeking alternatives to st and ard group support in coping with their illness . This study examines outcomes for 181 women with breast cancer r and omized to either a 12-week st and ard group support or a 12-week complementary and alternative medicine ( CAM ) support intervention .  Participants in the CAM group were taught the use of meditation , affirmation , imagery and ritual . The st and ard group combined cognitive-behavioral approaches with group sharing and support . Both interventions were found to be associated with improved quality of life ( CAM , P=0.008 ; St and ard , P=0.006 ) , decreased depression ( CAM , P=0.004 ; St and ard , P=0.02 ) , decreased anxiety ( CAM , P=0.0003 ; St and ard , P=0.02 ) and increased " spiritual well-being " ( CAM , P=002 ; St and ard , P=0.003 ) . Only the CAM group showed increases in measures of Spiritual Integration ( P=0.001 ) which were also significant between groups ( P=0.003 ) . The St and ard group was associated with decreased confusion ( P=0.01 ) and decreased helplessness/hopelessness ( P=0.01 ) , while the CAM group was associated with decreased avoidance ( P=0.01 ) . None of these latter changes were significant between groups . At baseline , very high correlations were noted between measures of quality of life , mood , and spiritual integration . At the end of the intervention , the CAM group showed higher satisfaction ( P=0.006 ) and fewer dropouts ( P=0.006 ) compared to the st and ard group . Better outcomes in quality of life in the CAM group were associated with lower initial fighting spirit ( r=-.39 , P=0.001 ) . No baseline factors predicted better outcomes in the St and ard group . In summary , the study found equivalence on most psychosocial outcomes between the two interventions We propose a two-stage r and omized clinical trial design for separating treatment effects from those result ing from choosing treatment . At the first stage all patients are r and omly allocated to one of two groups , the r and om group and the option group . At the second stage , patients in the r and om group are r and omized a second time to treatment A or B , whereas patients in the option group are given a free choice between the two treatments . If there are differences in treatment response between the r and om group and the option group , there are two potential sources of bias : self- selection by choosing treatment , and effects of suggestion by receiving the preferred treatment . A linear model is presented to estimate these effects separately along with test statistics which are approximately normally distributed We examined the long-term effects of a behavioral intervention on the psychological distress of patients recently diagnosed with localized cancer , who were being treated at Hadassah University Hospital . All 116 patients who met the inclusion criteria ( 49 men and 67 women ) were r and omized into an intervention group and a control group on a 3:1 basis . The intervention chosen was Progressive Muscle Relaxation with Guided Imagery , which is intended to decrease psychological distress and increase the patient 's sense of internal control . The Brief Symptom Inventory ( BSI ) and the Impact of Events Scale ( IES ) were used to assess psychological distress within 1 month of diagnosis , 3 months later ( shortly before starting intervention ) , and 6 months after the end of the intervention . At the final assessment , the effect of the  behavioral intervention  on psychological distress was positive . The effect was relatively modest but statistically significant when assessed in terms of the Global Severity Index ( GSI ) ( a decrease of 2.3 points in the GSI of the treatment group as compared to an increase of 1.2 points in the GSI of the control group P=.005 ) . Despite these moderately positive findings , we suggest that the results might be more meaningful if cancer patients are first screened for psychological distress to exclude those with a low distress level that does not justify intervention , and only then r and omized for participation in the study PURPOSE / OBJECTIVES To test the effects of a computer-based nursing intervention design ed to provide patients and family caregivers with concrete , objective information on symptom management ; provide education about disease and treatment ; coordinate medical re sources ; and provide emotional support and counseling . DESIGN Two-site , r and omized clinical trial . SETTING S A large , urban , midwestern , tertiary-cancer center and a community-based cancer center in a medium-sized midwestern city . SAMPLE 109 patients newly diagnosed with breast , colon , or lung cancer who were receiving chemotherapy ; 54 received st and ard care , and 55 participated in the intervention group .  METHODS Outcome data were collected via structured telephone interviews at three time points : baseline , midway through the intervention , and one month postintervention . The intervention consisting of nine visits , five in person and four by telephone , was conducted over 18 weeks by advanced practice oncology nurses . MAIN RESEARCH VARIABLES Psychosocial functioning , anxiety , and depression . FINDINGS Patients who received the intervention had significantly less depression between baseline and the midway point , as well as less anxiety and greater improvement in the role-emotional and mental health subscales of the Medical Outcomes Study 36 Short Form . CONCLUSIONS Cancer-care nursing interventions can decrease psychosocial morbidity and improve quality of life for newly diagnosed patients with cancer undergoing treatment . Additional research is needed to underst and who benefited most from the intervention . IMPLICATION S FOR NURSING This nurse-directed intervention result ed in improved mental health for patients ; however , physical subscales were not changed . Further work is needed to determine why depression and mental health were affected yet physical health and symptoms did not differ between groups . Results support the important role of nurses in addressing mental health issues in patients and families experiencing cancer As many as 80 % of breast cancer patients report significant distress during initial treatment , yet there is little in the way of systematic psychotherapeutic interventions for women coping with the stress of a recent diagnosis of breast cancer . The literature on psychotherapeutic treatment of cancer patients provides uniform evidence for an improvement in mood , coping and adjustment as a result of group therapy . The present study examined the feasibility of implementing a manualized treatment , supportive-expressive group psychotherapy , in busy oncology practice s across the US . This intervention was applied to women with primary breast cancer in a manner which tests not only the efficacy of the approach but also its accessibility to group therapists not previously experienced in its use . One hundred and eleven breast cancer patients within 1 year of diagnosis were recruited from ten geographically diverse sites of the National Cancer Institute 's Community Clinical Oncology Program ( CCOP ) and two academic medical centers . Two therapists from each site were trained in supportive-expressive group psychotherapy . Training consisted of participation in a workshop , reading a treatment manual , and viewing explanatory videotapes . Each patient participated in a supportive-expressive group that met for 12 weekly sessions lasting 90 min . Assessment of mood disturbance was made at entry , 3 , 6 , and 12 months . Results indicated a significant 40 % decrease in the Total Mood Disturbance ( TMD ) scores of the Profile of Mood States ( POMS ) ( ANOVA F [2,174]=3.98 , p<0.05 ) . The total symptom score of the Hospital Anxiety and Depression Scale ( HADS ) was likewise significantly reduced over the 6-month period ( F [ 2 , 174]=5.2 , p<0.01 ) . Similarly , the total score of the Impact of Event Scale ( IES ) was significantly reduced ( F [2,174]=4.0 , p<0.05 ) . There was substantial uniformity of treatment effect across sites . Outcome was independent of stage of disease ( I vs. II ) . We conclude that this treatment program can be effectively implemented in a community setting and results in reduced distress among breast cancer patients Communication between physicians and advanced cancer patients is frequently difficult . Patients often report poor levels of satisfaction with communication . The purpose of this study was to assess the impact on patients ' recall of and overall satisfaction with their consultation by the addition of an audiocassette recording of a consultation to written recommendations BACKGROUND AND OBJECTIVE R and omization does not protect against bias due to missing observations . In addition , different reasons for missing observations may lead to different invalid results . The purpose of this study was to illustrate how r and omized intervention studies can be threatened by bias due to missing observations because of death or nonresponse . METHODS A r and omized clinical trial of the effect of  psychosocial intervention on well-being after an operation for colorectal cancer was conducted in Denmark . Patients were interviewed 3 , 6 , 12 , and 24 months after discharge from hospital . RESULTS We found that the probability of nonresponse decreased with increasing anxiety score in the intervention group , but it increased with increasing anxiety score in the control group . This could lead to severe bias in an analysis of the effect of intervention on anxiety . Low physical functioning and low global health status and quality of life were related to an increased probability of dying before the next follow-up , and this association could explain the associations between anxiety and depression , respectively , and the probability of dying observed in crude analyses . CONCLUSION Our study emphasizes the importance of performing specific missing data analyses in any study of well-being variables Abstract OBJECTIVE : This study was initiated by breast cancer survivors living in a rural community in California . They formed a partnership with academic research ers to develop and evaluate a low-cost , community-based Workbook-Journal ( WBJ ) for improving psychosocial functioning in geographically and economically isolated women with primary breast cancer . DESIGN : A r and omized controlled trial was used to compare the WBJ intervention plus educational material s to educational material s alone ( usual care ) . SETTING : One rural cancer center and several private medical , surgical , and radiation oncology practice s in 7 rural counties in the Sierra Nevada Foothills of California . PARTICIPANTS : One hundred women with primary breast cancer who were either within 3 months of diagnosis or within 3 months of completing treatment . INTERVENTION : A community-initiated , theoretically-based Workbook-Journal , design ed by rural breast cancer survivors and providers as a support group alternative . It included compelling personal stories , local rural re sources , coping strategies , and messages of hope . RESULTS : Community recruiters enrolled 83 % of the women referred to the study . Retention at 3-month follow-up was 98 % . There were no main effects for the WBJ . However , 3 significant interactions suggested that women who were treated in rural practice s reported decreased fighting spirit and increased emotional venting and posttraumatic stress disorder symptoms if they did not receive the WBJ . Among women who received the WBJ , 74 % felt emotionally supported . CONCLUSIONS : This community-based Workbook-Journal may be an effective psychosocial intervention for rural , isolated , and low-income women with breast cancer . Community involvement was essential to the success of this project The effectiveness of support group interventions for cancer patients has been established among White patients but has been virtually unstudied among minority patients . The current study represents the 1st r and omized support group intervention targeted to African American women with breast cancer . Participants ( N = 73 ) with nonmetastatic breast cancer were r and omly assigned to an 8-week group intervention or an assessment -only control condition At 12 months , the intervention result ed in improved mood as well as improved general and cancer-specific psychological functioning among women with greater baseline distress or lower income . Subsequent research is needed to address effective methods of enrolling and following women with fewer psychosocial and financial re sources , as they were the most likely to benefit from this particular intervention PURPOSE / OBJECTIVES To evaluate quality of life ( QOL ) and cost outcomes of advanced practice nurses ' ( APNs ' ) interventions with women diagnosed with breast cancer . DESIGN R and omized clinical trial . SETTING Integrated healthcare system in a midwestern suburban community . SAMPLE 210 women with newly diagnosed breast cancer with an age range of 30 - 85 years . METHODS The control group ( n = 104 ) received st and ard medical care . The intervention group ( n = 106 ) received st and ard care plus APN interventions based on Brooten 's cost- quality model and the Oncology Nursing Society 's st and ards of advanced practice in oncology nursing QOL was measured using the Functional Assessment of Cancer Therapy , Mishel Uncertainty in Illness Scale and Profile of Mood States at seven intervals over two years . Information about costs ( charges and reimbursement ) was collected through billing systems . MAIN RESEARCH VARIABLES Uncertainty , mood states , well-being , charges , and reimbursement . FINDINGS Uncertainty decreased significantly more from baseline in the intervention versus control group at one , three , and six months after diagnosis ( p = 0.001 , 0.026 , and 0.011 , respectively ) , with the strongest effect on subscales of complexity , inconsistency , and unpredictability . Unmarried women and women with no family history of breast cancer benefited from nurse interventions in mood states and well-being . No significant cost differences were found . CONCLUSIONS APN interventions improved some QOL indicators but did not raise or lower costs . IMPLICATION S FOR NURSING PRACTICE The first six months after breast cancer diagnosis is a critical time during which APN interventions can improve QOL outcomes . More research is necessary to define cost-effective interventions BACKGROUND / AIMS The impact of psychotherapeutic support on survival time in patients with gastrointestinal cancer undergoing surgery was studied . METHODOLOGY A r and omized controlled trial was conducted in cooperation with the Departments of General Surgery and Medical Psychology , University Hospital of Hamburg , Germany . Two hundred and seventy-one consenting patients with a preliminary diagnosis of cancer of the esophagus , stomach , liver/gallbladder , pancreas or colon/rectum were stratified by gender and r and omly assigned to a control group that received st and ard care , as provided on the surgical wards , or to an experimental group that received formal psychotherapeutic support in addition to routine care during the hospital stay . Patients in both groups completed the EORTC- Quality of Life question naire pre-operatively , post-operatively , and at 3 , 6 , 12 , and 24 months following surgery . Date of death , if applicable , was also recorded . Unadjusted and adjusted survival analyses were performed . RESULTS Kaplan-Meier survival curves demonstrated better survival for the experimental group than for the control group . The unadjusted significance level for group differences was p = 0.002 for survival up to 2 years . Cox regression models that took TNM Staging or the Residual Tumor Classification into account also found significant differences at the 2-year follow-up . Secondary analyses found that most of the differences in favor of the experimental group occurred in females and in patients with stomach , pancreatic , primary liver or colorectal cancer . CONCLUSIONS The results of this study indicate that patients with gastrointestinal cancer , particularly those who are female and those who undergo surgery for stomach , pancreatic , primary liver or colorectal cancer , benefit from a formal program of psychotherapeutic support in terms of survival A recent Pew Charitable Trust study found that 52,000,000 individuals used the Internet to obtain health/medical information . Clinical trials of face‐to‐face breast carcinoma support groups show evidence of 1 ) improvement in quality of life , 2 ) reduction of psychologic symptoms , 3 ) improvement in coping responses , and 4 ) a reduction in pain . To the authors ' knowledge , a few studies published to date have investigated Internet‐delivered electronic support groups ( ESGs ) for cancer . The most sophisticated is the Comprehensive Health Enhancement Support System ( CHESS ) program , which provides integrated information , referral , and a newsgroup‐based social support program . However , to the authors ' knowledge , no studies published to date have examined the impact of a breast carcinoma ESG in a clinical trial This trial compared pain , quality of life , and analgesic use in a sample of patients with cancer pain ( n=24 ) who received either st and ard opioid management plus rest ( Arm A ) or st and ard opioid management plus Reiki ( Arm B ) . Participants either rested for 1.5 hr on Days 1 and 4 or received two Reiki treatments ( Days 1 and 4 ) one hour after their first afternoon analgesic dose . Visual analogue scale ( VAS ) pain ratings , blood pressure , heart rate , and respirations were obtained before and after each treatment/rest period . Analgesic use and VAS pain scores were reported for 7 days . Quality of life was assessed on Days 1 and 7 . Participants in Arm B experienced improved pain control on Days 1 and 4 following treatment , compared to Arm A , and improved quality of life , but no overall reduction in opioid use . Future research will determine the extent to which the benefits attributed to Reiki in this study may have been due to touch Physical exercise has been shown to enhance quality of life ( QOL ) in cancer survivors using pretest-posttest design s and compared to usual care ( i.e. no intervention ) . In the present study , we conducted a r and omized controlled trial to determine if exercise could improve QOL in cancer survivors beyond the known benefits of group psychotherapy ( GP ) . We matched 22 GP classes ( N=108 ) on content and then r and omly assigned 11 ( n=48 ) to GP alone and 11 ( n=60 ) to GP plus home-based , moderate-intensity exercise ( GP+EX ) . Participants completed a physical fitness test and QOL measures ( e.g. Functional Assessment of Cancer Therapy scales ) at the beginning and end of GP classes ( about 10 weeks ) . We had excellent recruitment ( 81 % ) , retention ( 89 % ) , and adherence ( 84 % ) rates and a modest contamination ( 22 % ) rate . Using intention-to-treat repeated measures analyses of variance , we found significant Time by Condition interactions for functional well-being , fatigue , and sum of skinfolds . We also found borderline significant interactions for physical well-being , satisfaction with life , and flexibility . All interactions favored the GP+EX condition . We conclude that a home-based , moderate intensity exercise program may im-prove QOL in cancer survivors beyond the benefits of GP , particularly in relation to physical and functional well-being Fatigue is the most prevalent and debilitating symptom experienced by breast cancer patients receiving adjuvant chemotherapy or radiation therapy and few evidence -based treatments are available to manage this distressing side-effect . The purpose of this multi-institutional r and omized controlled trial was to determine the effects of exercise on fatigue levels during treatment for breast cancer . Sedentary women ( N=119 ) with Stage 0-III breast cancer receiving outpatient adjuvant chemotherapy or radiation therapy were r and omized to a home-based moderate-intensity walking exercise program or to usual care for the duration of their cancer treatment . Of participants r and omized to exercise , 72 % adhered to the exercise prescription ; 61 % of the usual care group adhered . The intention-to-treat analysis revealed no group differences in part because of a dilution of treatment effect as 39 % of the usual care group exercised and 28 % of the exercise group did not . When exercise participation was considered using the data analysis method of instrumental variables with principal stratification , a clinical ly important and statistically significant ( p=0.03 ) effect of exercise on pretest-to-posttest change in fatigue levels was demonstrated . Adherence to a home-based moderate-intensity walking exercise program may effectively mitigate the high levels of fatigue prevalent during cancer treatment Home visits by health care professionals may constitute a formalized social relationship in which cancer patients can be given emotional and informational support . We aim ed at study ing the effect of home visits on the well-being of colorectal cancer patients . A total of 249 Danish colorectal cancer patients undergoing abdominal surgery were r and omly assigned to a control group or to an intervention group . The intervention group received 10 home visits carried out by a project nurse or a medical doctor during the first 2 years after discharge . Participants were interviewed 3 , 6 , 12 , and 24 months after discharge in order to assess well-being . Using a linear mixed model , we found no overall effect of the intervention on well-being . We recommend that future psychosocial intervention studies include baseline screening for distress and recommend testing the effect of shorter but intensive interventions carried out by trained therapists Concerns about reporting pain and using analgesics ultimately can contribute to poor pain management for many individuals . A nursing intervention to address these " patient-related barriers " was developed based on Johnson 's self-regulation theory . The purpose of this pilot study was to determine whether provision of individually tailored sensory and coping information about analgesic side effects and specific information to counter misconceptions would enhance pain management in a sample of 43 women with gynecologic cancers . It was hypothesized that at 1-month post-test and 2-month follow-up , those subjects r and omized to the information condition would ( a ) have lower barriers scores ; ( b ) use more adequate analgesic medication ; ( c ) have lower analgesic side effect scores ; ( d ) have lower pain intensity scores ; and ( e ) experience less pain interference with life and better overall quality of life compared to those in the care-as-usual control group . There was no main effect for group on any of the dependent variables . Rather , all women reported a decrease in barriers between baseline and 2-month follow-up ( p<.05 ) ; all subjects experienced a decrease in pain interference with life scores between baseline and 1-month post-test ( p<.05 ) ; and there was a significant shift of women from unacceptable pain management at baseline to acceptable pain management at 1-month post-test ( p<.05 ) . In addition , the majority of women reported that the intervention contained novel and useful information that helped them to feel more comfortable taking pain medication , to be less concerned about addiction , and helped them talk more openly about pain with a doctor or nurse
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