this study was conducted within the north central cancer treatment group , a national cancer cooperative group that is funded in part by the national cancer institute . questionnaire and clinical trial data from two separate cancer therapeutic trials , n9921 and
these two trials recruited patients between february 2000 and february 2001 and between december 2004 and february 2006 , respectively . the present study s design was formulated prior to the initiation of the first trial and entailed merging and analyzing data from both of these prospectively conducted clinical trials .
eligibility criteria for these two trials focused on selecting patients who could tolerate the chemotherapy agents , gefitinib , paclitaxel , and carboplatin , which were used in one or both of the trials mentioned above .
these criteria are described in greater detail elsewhere,14,15 but relevant factors consistent between both trials included the following : 1 ) patient aged 65 years or older ; 2 ) eastern cooperative group performance score ( an often - utilized score that describes the level of function of cancer patients ) of 0 , 1 , or 2 ; 3 ) histologic or cytologic confirmation of non - small cell lung cancer ; 4 ) unresectable cancer ; 5 ) no prior chemotherapy ; 6 ) physician - anticipated life expectancy of 12 weeks or longer ; and 7 ) absence of a major medical illness that would preclude participation in a therapeutic cancer clinical trial .
in addition , all patients had to have had adequate organ function , as demonstrated by an acceptable hemogram , liver function tests , and serum creatinine at the time of study enrollment .
other eligibility criteria were more specific to each chemotherapy regimen patients were about to receive , such as , for example , an exclusion of patients with severe neuropathy in the event they were to receive paclitaxel .
all eligible patients completed the lubben social network scale within 14 days of trial registration and prior to receiving any chemotherapy .
this 12-item instrument has been previously validated , has been tested in a variety of settings , and includes questionnaire items that are highly germane to defining extent of social support.16 thereafter patients were treated with one of the following chemotherapy regimens : 1 ) weekly carboplatin and paclitaxel ( intravenous ) ; 2 ) weekly carboplatin and paclitaxel ( intravenous ) potentially for four months followed by daily gefitinib ( oral ) ; or 3 ) daily gefitinib ( oral ) .
patients were to continue cancer therapy until evidence of cancer progression , until unacceptable side effects occurred , or , for a maximum of four months , if they were receiving conventional chemotherapy .
they were monitored indefinitely for cancer therapy - related side effects by means of the common terminology criteria , version 2 from the national cancer institute.17 tumor response as assessed by the recist criteria,18 and overall survival was assessed .
the sample sizes for the two individual trials were calculated to obtain adequate statistical power for the primary aims of these clinical trials , not for the social support aims .
nonetheless , for the current study , we conducted a retrospective power calculation for the comparisons of two independent means to evaluate the power available for comparing the lubben social support score by the dichotomous factors of gender , performance score , and severe adverse events .
the sample size of 113 ( 56 in each group ) with an observed standard score deviation of 17 and an observed median social support score of 72 yields 84% power to detect a difference of 12 points ( 60 versus 72 ) using a two - sided alpha of 0.007 .
scores from the lubben social support network ( items 110 on table 2 ) were summed for analyses and then transformed to a 100% scale .
a score of 0 represents the lowest possible level of social support ; whereas , a score of 100 represents the highest possible level of social support . to transform the scores to a 100% scale ,
a patient s individual score was divided by the patient s possible range accounting for any missed items ( maximum minus minimum ) and multiplied by 100 .
a rank sum test was used to evaluate whether social support scores differed based on the characteristics of gender , age ( > = 70 ) , and performance status .
similarly , a rank sum test was also used to evaluate whether social support scores differed between patients who suffered more severe adverse events ( grade 3 or worse ) versus those who did not .
time - to - cancer progression was defined as the time from registration to documentation of cancer progression .
survival time was defined as the time from study registration to death due to any cause .
a cox proportional hazards model , which adjusted for cancer treatment , performance score , age , gender , and sum of target lesions at baseline , was used to evaluate whether social support scores were related to time - to - cancer progression or overall survival . in order to illustrate the influence of social support on overall survival , we divided the cohort by social support score quartiles .
no widely accepted cut - points exist to separate social support into categories , so quartiles were used to distribute evenly the 113 patients into four groups .
a logistic regression model , which adjusted for the same baseline factors mentioned above , was used to assess relationships between social support and adverse events .
because of the exploratory nature of these analyses and because of the number of statistical tests performed , a p - value of < 0.01 was considered statistically significant . this decision to utilize this p - value
was based on the computation that the overall conventional alpha level is 0.05 and that seven multiple comparisons were made with a bonferroni adjustment .
all statistical analyses were conducted with sas software ( sas institute , cary , nc , usa ) .
this study was conducted within the north central cancer treatment group , a national cancer cooperative group that is funded in part by the national cancer institute . questionnaire and clinical trial data from two separate cancer therapeutic trials , n9921 and
these two trials recruited patients between february 2000 and february 2001 and between december 2004 and february 2006 , respectively . the present study s design was formulated prior to the initiation of the first trial and entailed merging and analyzing data from both of these prospectively conducted clinical trials .
eligibility criteria for these two trials focused on selecting patients who could tolerate the chemotherapy agents , gefitinib , paclitaxel , and carboplatin , which were used in one or both of the trials mentioned above .
these criteria are described in greater detail elsewhere,14,15 but relevant factors consistent between both trials included the following : 1 ) patient aged 65 years or older ; 2 ) eastern cooperative group performance score ( an often - utilized score that describes the level of function of cancer patients ) of 0 , 1 , or 2 ; 3 ) histologic or cytologic confirmation of non - small cell lung cancer ; 4 ) unresectable cancer ; 5 ) no prior chemotherapy ; 6 ) physician - anticipated life expectancy of 12 weeks or longer ; and 7 ) absence of a major medical illness that would preclude participation in a therapeutic cancer clinical trial .
in addition , all patients had to have had adequate organ function , as demonstrated by an acceptable hemogram , liver function tests , and serum creatinine at the time of study enrollment .
other eligibility criteria were more specific to each chemotherapy regimen patients were about to receive , such as , for example , an exclusion of patients with severe neuropathy in the event they were to receive paclitaxel .
all eligible patients completed the lubben social network scale within 14 days of trial registration and prior to receiving any chemotherapy .
this 12-item instrument has been previously validated , has been tested in a variety of settings , and includes questionnaire items that are highly germane to defining extent of social support.16 thereafter patients were treated with one of the following chemotherapy regimens : 1 ) weekly carboplatin and paclitaxel ( intravenous ) ; 2 ) weekly carboplatin and paclitaxel ( intravenous ) potentially for four months followed by daily gefitinib ( oral ) ; or 3 ) daily gefitinib ( oral ) .
patients were to continue cancer therapy until evidence of cancer progression , until unacceptable side effects occurred , or , for a maximum of four months , if they were receiving conventional chemotherapy .
they were monitored indefinitely for cancer therapy - related side effects by means of the common terminology criteria , version 2 from the national cancer institute.17 tumor response as assessed by the recist criteria,18 and overall survival was assessed .
the sample sizes for the two individual trials were calculated to obtain adequate statistical power for the primary aims of these clinical trials , not for the social support aims .
nonetheless , for the current study , we conducted a retrospective power calculation for the comparisons of two independent means to evaluate the power available for comparing the lubben social support score by the dichotomous factors of gender , performance score , and severe adverse events .
the sample size of 113 ( 56 in each group ) with an observed standard score deviation of 17 and an observed median social support score of 72 yields 84% power to detect a difference of 12 points ( 60 versus 72 ) using a two - sided alpha of 0.007 .
scores from the lubben social support network ( items 110 on table 2 ) were summed for analyses and then transformed to a 100% scale .
a score of 0 represents the lowest possible level of social support ; whereas , a score of 100 represents the highest possible level of social support . to transform the scores to a 100% scale ,
a patient s individual score was divided by the patient s possible range accounting for any missed items ( maximum minus minimum ) and multiplied by 100 .
a rank sum test was used to evaluate whether social support scores differed based on the characteristics of gender , age ( > = 70 ) , and performance status .
similarly , a rank sum test was also used to evaluate whether social support scores differed between patients who suffered more severe adverse events ( grade 3 or worse ) versus those who did not .
time - to - cancer progression was defined as the time from registration to documentation of cancer progression .
survival time was defined as the time from study registration to death due to any cause .
a cox proportional hazards model , which adjusted for cancer treatment , performance score , age , gender , and sum of target lesions at baseline , was used to evaluate whether social support scores were related to time - to - cancer progression or overall survival . in order to illustrate the influence of social support on overall survival , we divided the cohort by social support score quartiles .
no widely accepted cut - points exist to separate social support into categories , so quartiles were used to distribute evenly the 113 patients into four groups .
a logistic regression model , which adjusted for the same baseline factors mentioned above , was used to assess relationships between social support and adverse events .
because of the exploratory nature of these analyses and because of the number of statistical tests performed , a p - value of < 0.01 was considered statistically significant . this decision to utilize this p - value
was based on the computation that the overall conventional alpha level is 0.05 and that seven multiple comparisons were made with a bonferroni adjustment .
all statistical analyses were conducted with sas software ( sas institute , cary , nc , usa ) .
a total of 113 patients met the eligibility criteria , received chemotherapy on a clinical trial , and therefore participated in the current study .
one patient did not receive chemotherapy , and two did not meet the eligibility criteria described earlier ; thus , these three patients are not included in the analyses .
forty - two percent of the cohort consisted of women , and the median age ( range ) was 74 years ( 65 , 91 ) . at the time of study entry , a performance score of 0 , 1 , or 2 was observed in 29% , 55% , and 16% of the cohort , respectively .
lubben social network scale data are summarized in table 2 . of note , 44% of patients reported that they see nine or more relatives at least once a month , and 27% reported that they see five to eight .
in addition , 73% reported that when they have an important decision to make , they 
always  have someone who can take them to their medical appointments , and 71% reported that they  always  have someone from whom they can seek help if they have medication side effects .
the median transformed social support score for the entire cohort ( range ) was 72 ( 30100 ) .
it should be noted that , although normative reference data are not readily available , a community - based study among a group of 7,524 older individuals observed a similarly - derived , average social support score of 63.19 among women and men in the present study , the average score was not statistically different : 72 in both ( rank sum , p = 0.87 ) ( figure 1 ) .
additionally , there was no statistically significant difference in social support scores among patients with an eastern cooperative oncology group performance score of 0 versus 1 and 2 : median score 74 and 70 ( rank sum , p = 0.06 ) .
although there was a trend to suggest that higher social support scores ironically predicted a shorter time - to - cancer - progression ( p = 0.02 ; hazard ratio [ hr ] = 1.02 ; 95% confidence interval [ ci ] : 1.001.03 ) , these scores did not predict overall survival ( p = 0.34 ; hr = 1.01 ; 95% ci : 0.991.02 ) ( figure 2 ) .
there was also no statistically significant difference in scores between patients who suffered grade 3 or worse adverse events and those who did not : median score 74 and 70 ( rank sum , p = 0.28 ) ( adjusted logistic regression p = 0.70 ; odds ratio [ or ] = 1.00 ; 95% ci : 0.971.02 ) ( table 3 ) .
a total of 113 patients met the eligibility criteria , received chemotherapy on a clinical trial , and therefore participated in the current study .
one patient did not receive chemotherapy , and two did not meet the eligibility criteria described earlier ; thus , these three patients are not included in the analyses .
forty - two percent of the cohort consisted of women , and the median age ( range ) was 74 years ( 65 , 91 ) . at the time of study entry , a performance score of 0 , 1 , or 2 was observed in 29% , 55% , and 16% of the cohort , respectively .
lubben social network scale data are summarized in table 2 . of note , 44% of patients reported that they see nine or more relatives at least once a month , and 27% reported that they see five to eight .
in addition , 73% reported that when they have an important decision to make , they  always  have someone to talk with .
always  have someone who can take them to their medical appointments , and 71% reported that they  always  have someone from whom they can seek help if they have medication side effects .
the median transformed social support score for the entire cohort ( range ) was 72 ( 30100 ) .
it should be noted that , although normative reference data are not readily available , a community - based study among a group of 7,524 older individuals observed a similarly - derived , average social support score of 63.19 among women and men in the present study , the average score was not statistically different : 72 in both ( rank sum , p = 0.87 ) ( figure 1 ) .
additionally , there was no statistically significant difference in social support scores among patients with an eastern cooperative oncology group performance score of 0 versus 1 and 2 : median score 74 and 70 ( rank sum , p = 0.06 ) .
although there was a trend to suggest that higher social support scores ironically predicted a shorter time - to - cancer - progression ( p = 0.02 ; hazard ratio [ hr ] = 1.02 ; 95% confidence interval [ ci ] : 1.001.03 ) , these scores did not predict overall survival ( p = 0.34 ; hr = 1.01 ; 95% ci : 0.991.02 ) ( figure 2 ) .
there was also no statistically significant difference in scores between patients who suffered grade 3 or worse adverse events and those who did not : median score 74 and 70 ( rank sum , p = 0.28 ) ( adjusted logistic regression p = 0.70 ; odds ratio [ or ] = 1.00 ; 95% ci : 0.971.02 ) ( table 3 ) .
the present study was designed to assess and evaluate the role of social support in a group of geriatric non - small cell lung cancer patients who were enrolled in two different cancer therapeutic clinical trials .
this study found that this cohort of geriatric patients had high levels of social support , as suggested by the fact that 81% reported that they 
always  had someone who could take them to medical appointments , and 71% reported that they  always  had someone from whom they could seek help if they had medication side effects .
however , social support was not associated with improved survival or diminished side effects from chemotherapy . moreover , no differences were observed between men and women in terms of baseline social support .
thus , although previous studies have reported that social support carries a positive impact on clinical outcomes and although gender differences in extent of social support have been hypothesized , the present study did not observe such findings .
why might the results of this study be divergent from the others that preceded it ?
first , relying on a clinical trial to answer such questions provides a solid infrastructure that ensures reliable outcome data .
the fact that all clinical trial participants were followed prospectively in such a thorough and systematic fashion makes it unlikely that patients  particularly those who have poor social support and who are thereby especially vulnerable to being lost to follow up  would , in fact , be lost to follow up .
such artificially compromised outcomes were side - stepped by building the study around two clinical trials , as was done here .
thus , the present study s meticulous follow up may have allowed for a more definitive and accurate assessment of the predictive capabilities  or lack thereof  of social support .
second , and more importantly , one might argue that patients willingness to participate in a clinical trial is associated with a high level of social support and that this selection bias may have contributed to the lack of differences between groups .
the fact that 82% of patients reported that they  always  had someone to bring them to medical appointments speaks to the possibility that this group as a whole has a high level of social support .
similarly , the median social support score of 72 in this study appears greater than the 63 score derived from a community - based study , an observation that also suggests cancer clinical trial participants have high levels of social support.19 in short , although the findings from this study suggest that social support does not influence clinical outcomes , these findings might pertain to only a culled group of geriatric clinical trial participants .
future studies may choose to focus further on the extent of social support among geriatric patients who participate in clinical trials , and further studies may also choose to study further whether social support is a predictive factor for the patients who can and do enroll in cancer clinical trials . two final points merit further discussion .
first , although the current study did not find that social support was predictive of outcomes , there are a variety of other potentially clinically relevant factors that had not been captured and adjusted for .
these include socioeconomic status , ongoing tobacco use , use of nutritional supplements , as well as several other factors .
other investigators may choose to further study the issue of social support in the context of these other factors .
second , although this study found that social support is not associated with clinical outcomes among elderly lung cancer patients , there remains no question that these patients have major needs that are likely exacerbated by a lack of social support .
patients with metastatic non - small cell lung cancer suffer from a poor prognosis , as seen from both studies presented here where the prognosis was poor , and previous studies have demonstrated that elderly patients suffer from a wide constellation of cancer - related symptoms , including depression , guilt , debility , pain , and dyspnea.1013 although the present study did not observe an association between social support and clinical outcomes , there nonetheless remains a strong need for maximizing social support to help with some of the cancer - related challenges these patients face .
 background : social support is defined as a network of family / friends who provide practical and emotional help . 
 a sizable literature describes a direct relationship between social support and improved cancer clinical outcomes . 
 this study explored the extent of social support and its potential association with survival and adverse events in geriatric lung cancer patients.methods:one hundred thirteen patients , who were aged 65 years or older , had incurable cancer , and were enrolled in one of two chemotherapy trials , completed the lubben social network scale , a validated instrument that measures social support . 
 all were followed for survival and chemotherapy - related adverse events.results:the median age ( range ) of the cohort was 74 years ( 6591 ) , and performance scores of 0 , 1 , or 2 were observed in 29% , 55% , and 16% , respectively . 
 forty - two percent were women . 
 this cohort had a high level of social support : 81% reported they  always  had someone to take them to medical appointments . however , there were no gender - based differences in social support and no associations between social support and either survival or adverse events.conclusion:in this cohort of geriatric lung cancer patients  all of whom were treated during a clinical trial  there was a high level of social support . 
 however , there were no gender - based differences in extent of social support , and the latter did not predict clinical outcomes . 
Materials and methods
Overview
Patient eligibility
Patient enrolment and follow-up
Statistical analyses
Results
Demographics
Social support scores, gender, and clinical prediction
Discussion