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Factors Associated With Participation in a Prevention Trial Aimed at Reducing Biomarkers of Breast Cancer Risk

James Price Dillard
Department of Communication Arts & Sciences
The Pennsylvania State University-University Park

Bonnie J. F. Meyer
Department of Education Psychology, Counseling, and Special Education
The Pennsylvania State University-University Park

Denise H. Solomon
Department of Communication Arts & Sciences
The Pennsylvania State University-University Park

Andrea Manni
Division of Endocrinology, Diabetes, and Metabolism
The Pennsylvania State University-Hershey Medical Center

Corresponding Author: 
James Dillard
 HYPERLINK "mailto:JPD16@PSU.EDU" JPD16@PSU.EDU
814-865-7088: office
814-863-7986: fax

Running Head:
Participation in a Prevention Trial

Disclaimers:
None

ABSTRACT 
Purpose
Poor enrollment into prevention trials is a major obstacle to the conduct of clinical investigations. This study focuses on cognitive and affective influences on the decision to participate in a clinical trial aimed at reducing biomarkers of breast cancer risk.
Patients and Methods
Following a decision to participate or not in a clinical trial focused on reduction of breast cancer risk, women were recruited into the present study. In a telephone survey, they provided information about the perceived costs and benefits of participation in the trial, emotions involved in the decision, speed and difficulty of the decision, and satisfaction and regret following the decision.
Results
One hundred healthy women took part in the current study, 72 of whom had participated in the clinical trial, and 28 of whom had declined participation. Relative to nonparticipants, women who decided to enroll perceived more benefits and fewer costs, and they experienced more positive emotions and fewer negative emotions. Women who had enrolled in the clinical trial also made the decision more quickly, more easily, were more satisfied with it, and had fewer regrets than women who declined participation in the clinical trial.
Conclusion
The findings show participants to this clinical trial differ from nonparticipants in terms of antecedents, process, and outcomes of the decision to enroll. The results also highlight avenues to improve recruitment.
KEYWORDS: recruitment; accrual; enrollment; decision making; emotion; satisfactionINTRODUCTION 
Clinical trials are the gold standard for evaluating options for treatment and/or prevention of cancer. While there are many challenges to conducting a valid clinical trial, perhaps the single biggest obstacle is recruitment of participants. Although as many as 20% of patients are eligible to participate in clinical research, only 2-7% actually choose to do so.1-2 Recruitment is particularly problematic in prevention trials which include healthy subjects who fear toxicity from the intervention more than they appreciate the reduction in cancer risk3 Low rates of participation create serious problems for health care delivery. Under-enrolled trials take longer than they otherwise would, which delays the introduction of new regimens and postpones rejection of ineffectual alternatives. Poor accrual to trials also endangers medical science at a fundamental level. Low enrollment may produce non-representative samples, thereby constraining the generalizability of the findings and threatening the validity of the trial's conclusions. 
Improved understanding of how individuals decide to enter a trial could lead to strategies for increasing enrollment.4 In this project, we sought to deepen our understanding of the participation decisions along several lines. First, rational models of decision making emphasize the costs and benefits associated with different options.  In a study of enrollment into breast cancer treatment trials, Avis, Smith, Link, Hortobagyi, and Rivera5 asked participants and nonparticipants to evaluate seven perceived benefits and fifteen perceived drawbacks of joining a trial. We sought to test the utility of the same set of predictors in a breast cancer prevention trial.
One limitation to rational models of decision making is that they do not readily accommodate non-rational influences on decision making, such as emotion. Given research showing that emotions can have important effects on decision making,6-8 we included measures of both positive and negative emotions associated with the enrollment decision. Evidence of the unique effects of discrete emotions on judgment led us to maintain the measures as separate indices, rather than collapse them into the broader categories of positive and negative.9
Enrollment decisions are binary: participate or not. However, other features of the decision can be examined in more nuanced ways.10 For example, analysis of the speed and difficulty of the decision may yield insight into processes that undergird enrollment.11 Post-decision phenomena, such as satisfaction and regret12-13 index psychologically important outcomes14 that could influence subsequent decisions.15
We expected that studying the decision process broadly might contribute to a fuller understanding of the problem of accrual. Hence, we examined antecedents of the decision, aspects of the process itself, and outcomes of the choice to enroll versus not enroll.
RESEARCH PARTICIPANTS AND METHODS
	Sample. A clinical trial is conducted at Hershey Medical Center under the direction of one of us (AM) to assess the efficacy of combining Raloxifene with Lovaza (the FDA approved formulation of the omega-3 fatty acids docosahexaenoic acid [DHA] and eicosapentaenoic acid [EPA]) as a means of reducing breast density, a biomarker of breast cancer risk.16   The details of the clinical trial (NCT00723398) have been recently published by us.17  Briefly, the trial targeted healthy, postmenopausal women deemed to be at high risk of breast cancer based on breast density in excess of 25% at their yearly routine screening mammogram. Additional inclusion/exclusion criteria are detailed in our report17 Consistent with the demographics of the catchment area, 98% of the sample was white and 2% were of African descent.
	Within a year of being offered the opportunity to enroll in the clinical trial, 305 women were contacted by mail and invited to participate in the current study about their decision regarding enrollment in the clinical trial. This included 100% of the trial nonparticipants. Ultimately, 72 trial participants and 28 nonparticipants agreed to provide data about their enrollment decision. The response rate was 54% for trial participants and 16% for nonparticipants, which gave an overall response rate of 32% for the current study. Data were collected via telephone interview. Because inclusion/exclusion criteria combined with the catchment area produced a homogeneous sample, no additional demographic data were collected for the decision study.
Measures
	The primary variable of interest was measured with a single item What decision did you make concerning the preventive breast cancer trial (Yes, to participate vs. No, not to participate)? Other outcome measures included speed and difficulty of decision making, satisfaction with the decision, and regrets following the decision. The exact wording of these and all other measures appears in the text and tables of the Results section. Single items designed to measure a variety perceived costs and benefits were taken directly from Avis et al.,4 although some items were excluded because they were not relevant to this preventive trial (e.g., �too much blood drawn�). The emotion measures were single items whose validity was established in previous studies.18
Statistical Analyses
	Multiple imputation was used to estimate the 0.8% of the data that were missing.
Bivariate analyses utilized t or �2 statistics as appropriate to ordinal or categorical data. Given the difference in group sizes (72 vs. 28), equality of variances was not assumed when estimating t values. A forward step logistic regression model was used to estimate the multivariate associations with enrollment decision. 
RESULTS
Perceived Costs of Participation
	Respondents made judgments of the importance of 13 possible costs to participation in the clinical trial using a three-point response scale: (1 =) Not at all important, (2 =) Somewhat important, and (3 =) Very important. Table 1 summarizes mean responses broken by participants and nonparticipants. The means are ordered from highest to lowest in the participant group; standard deviations appear in parentheses. Significant differences at p < .05 were observed on three of the thirteen items: Nonparticipants reported higher perceived costs regarding (a) the possibility of side effects, (b) riskiness of the trial, and (c) the amount of time required by the trial. 
Table 1
Perceived Costs of the Decision to EnrollParticipantsNonparticipantstpThe possibility of side effects 1.99 (0.70)    2.57 (0.57)4.29.0001Didn't know what to expect 1.54 (0.60)    1.86 (0.84)1.83.07Might get less effective treatment 1.42 (0.66)    1.44 (0.82)0.34.73It was too risky1.31 (0.57)    2.00 (0.90)3.78.001Might not get the best treatment1.18 (0.48)    1.40 (0.80)1.20.23It disrupted your daily routine1.14 (0.38)    1.38 (0.62)1.78.083It took too much time1.14 (0.38)    1.45 (0.70)2.21.030Medical research can't be trusted  1.12 (0.44)    1.08 (0.38)0.57.56You would have felt like a guinea pig 1.11 (0.39)    1.14 (0.35)0.38.70Researchers care more about research than people 1.10 (0.38)    1.07 (0.26)0.35.72Transportation was a problem 1.08 (0.32)    1.19 (0.55)0.89.37Might have changed your relationship with a health care provider 1.08 (0.27)    1.13 (0.32)0.44.65Lack of privacy 1.04 (0.26)    1.20 (0.40)1.77.08Note. The participant and nonparticipant columns contain means and, in parentheses, standard deviations.
Perceived Benefits of Participation
	The importance of 7 possible benefits to participation was assessed on a three-point response scale: (1 =) Not at all important, (2 =) Somewhat important, and (3 =) Very important. Table 2 summarizes mean responses broken down by participants and nonparticipants. Three of the eight items showed significant differences at p < .05. Participants saw more benefit in trial enrollment as: (a) a way of helping others, (b) a way of doing something positive, and (c) a way of being involved in new treatments. 
Table 2
Perceived Benefits of the Decision to EnrollParticipantsNonparticipantstpIt was a way to help others 2.96 (0.20)    2.71 (0.46)2.70.011It was a way of doing something positive 2.92 (0.27)    2.61 (0.56)2.76.009It was a way of being involved in new preventive treatments 2.76 (0.48)    2.14 (0.84)3.64.001It allowed you to get more information 2.42 (0.70)    2.15 (0.86)1.44.15It was a way of reducing your chances of getting breast cancer 2.27 (0.81)    2.14 (0.84)0.66.50It was a way of having your health observed more closely 1.99 (0.83)    2.11 (0.89)0.63.53It meant access to the best medical care 1.76 (0.81)    2.11 (0.89)1.76.084It allowed you to see a health care provider more often 1.51 (0.69)    1.67 (0.73)0.93.35Note. The participant and nonparticipant columns contain means and, in parentheses, standard deviations.

Emotions Associated with the Participation Decision
	For six emotions, respondents were asked When you were deciding about the trial, did you ever feel [emotion]? Respondents who replied No were coded as 0 for that emotion. Respondents who replied Yes were asked Would you say that you were (1 =) a little [emotion], (2 =) moderately [emotion], or (3 =) Very [emotion]. Means responses partitioned on trial participation are in Table 3. Significant differences were found on four of the six items. Relative to nonparticipants, participants reported higher levels of hope, contentment, and happiness, as well as lower levels of sadness.
Table 3
Emotions Associated with the Decision to EnrollParticipantsNonparticipantstpHopeful 1.93 (1.05)    1.11 (0.95)3.75.0001Content 1.86 (1.13)    1.00 (1.24)3.18.003Happy 1.64 (1.21)    0.54 (1.03)4.55.0001Fearful 0.19 (0.43)    0.43 (0.87)1.34.187Sad 0.10 (0.38)    0.39 (0.68)2.15.038Angry 0.01 (0.11)    0.04 (0.18)0.57.573Note. The participant and nonparticipant columns contain means and, in parentheses, standard deviations.

Decision Features and Sequelae
	With regard to how quickly respondents made their decision to enroll in the trial or not, 43% reported that they did so before they left the doctor�s office (=1), 26% within a couple of days (=2), 16% within a week (=3), 7% within 2 weeks (=4), and 9% within a month (=5). Participants made a decision more quickly than nonparticipants (see Table 4, row 1).
	When asked How hard was it for you to make your decision about the trial? 78% chose Not hard at all (=1), 19% selected Somewhat hard (=2), and 3% chose A very hard decision (=3). Participants judged the decision as significantly less difficult than nonparticipants (see Table 4, row 2).
	Satisfaction was assessed by asking How satisfied are you with your decision overall? Responses in the full sample were: (1=) Not at all satisfied (4%), (2=) Somewhat satisfied (5%), (3=) Moderately satisfied (11%), and (4=) Very satisfied (80%). Trial participants were significantly more satisfied than nonparticipants (see Table 4, row 3).
	Eleven percent of the total sample responded affirmatively to the question Do you have any regrets about your decision? Non-participants reported post-decisional regret more frequently than participants (see Table 4, row 4).
Table 4
Features & Outcomes of the Decision to EnrollParticipantsNonparticipantsStatistic/ValuepSpeed 1.84 (1.31)    2.81 (1.48)    t =    3.18.003Difficulty 1.14 (0.38)    1.54 (0.62)    t =    3.08.004Satisfaction 3.86 (0.41)    3.18 (1.10)    t =    3.12.004Regrets (Yes) 1%    36%  �2 =  24.26.0001Note. Except for the row labeled Regrets, the participant and nonparticipant columns contain means and, in parentheses, standard deviations.
Multivariate Analyses
	A binary logistic regression used enrollment decision as the dependent measure, where 0 = not participate and 1 = participate. All other available variables were treated as statistical predictors. Thus, the set of independent variables included measures thought to be antecedents of the decision, such as perceived benefits and risks and emotions. It also included satisfaction and regret, which are properly conceived as outcomes of the decision. This set of variables was justified given that the goal of the analysis was to maximize discrimination between the two groups. 
	The forward step analysis, with an entry criterion of p < .05, yielded �2 (6) = 38.26, p < .0001, Nagelkerke R2 = .66 and included five substantive predictors plus the constant. Significance tests for individual terms were based on the Wald test. Attention to the odds ratios revealed significant effects for three types of benefits: Access, information, and a way to be involved. Information and involvement each increased the odds of enrollment by a factor of 5 or more. Judgments about access operated against expectations: Higher access judgments reduced the likelihood of enrollment. When happiness was associated with the decision to enroll, the odds of participation more than doubled. The experience of regret was high among women who declined participation. In sum, the multivariate analysis showed that a mix of cost, benefit, and emotion measures collectively predicted enrollment very well. 
Table 5
Predictors of Decision to Enroll   BSEOdds Ratio  pConstant-2.841.31     ----.001Happy 0.930.33    2.54.005Access to best medical care-2.340.72    0.09.001Allowed you to get more information 1.610.75    5.00.033Way of being involved 1.740.54    5.74.001Regrets-3.261.19    0.03.007

DISCUSSION
	The data show a multi-faceted profile of the decision by healthy subjects to enroll in a clinical trial aimed at reducing breast cancer risk. Participants were more favorable toward the trial in several distinct ways. For example, in cost/benefit terms they saw advantages to enrollment, the most important of which were helping others and doing something positive. Relative to nonparticipants, they also experienced higher levels of hope, contentment, and happiness. In addition, participants made the decision more easily and more rapidly than did nonparticipants. Following the decision, they were more satisfied and did not experience regrets. The overall pattern of data suggests an optimism that manifests itself across different aspects of the decision process.
	In contrast, nonparticipants focused on the potential costs of enrollment, especially side effects, risk, and loss of time. These barriers have been observed in previous studies of phase I-III clinical trials.5,19-20 There was no indication, however, that this sensitivity to risk produced strong negative emotions around the decision to participate. In fact, only a small fraction of the sample reported feeling even very low levels of fear and sadness. Nonparticipants also took longer to make the enrollment decision and reported more difficulty with it. Furthermore, they were less satisfied with the decision after having made it and were thirty six times more likely to report regret (1% vs. 36%). Overall, these results imply ambivalence about the decision to participate and suggest the potential of unforeseen costs to the psychological well-being of trial decliners.
	The multivariate analysis revealed an unexpected negative association between reporting that the trial would access to better medical care and the decision to participate. This finding may indicate misunderstanding of the item on the part of respondents.  Alternatively, it may be a marker for knowledge about medicine and clinical trials; that is, it is doubtful that participation in the clinical trial would give participants access to the best medical care and higher ratings on this benefit may reflect less knowledge about medicine and this particular clinical trial.  Knowledge relevant to medical decision-making has been shown to increase immediacy of decision-making. For example, nurses who were breast cancer patients made faster breast cancer treatment decisions than patients without this medical background.21 Additionally, participants with higher test scores on knowledge of breast cancer treatments made quicker breast cancer treatment decisions than participants who were lower test scores about breast cancer treatments. 10 In the current study, participants who volunteered for clinical trial were quicker to make their decision about whether or not to enroll in the study and also tended to have more knowledgeable/realistic views about access to the best medical care as a benefit for participation in the clinical trial (i.e., lower ratings on seeing access to the best medical care as a benefit of participation). 
	There are several implications for increasing enrollment into clinical trials. Reducing objective obstacles such as time and disruption would likely enhance accrual. In addition, perceived concerns about risk and trial side effects may be responsive to physician counseling. Of course, recruitment efforts must align with realistic estimates of the intrusiveness and riskiness of any trial. Prior research indicates that lack of information may influence the enrollment decision.22, 23 The current findings suggest that accrual might be enhanced by a stronger focus on specific types information, including the benefits of involvement and action (vs. inaction). Emphasis on enrollment as a way to help others is another potentially effective argument for enhancing trial participation. Finally, the data suggest value in informing potential participants that trial accepters experience higher satisfaction and fewer regrets. Providing potential participants with this information also aligns with the ethics of informed consent.
	There are both strengths and limitations to the study. For example, the study is unique in its focus on prevention, rather than treatment as in Phase I, II, or III trials. But, the results are limited by our examination of only one trial and by the demographic make-up of the catchment area. Differential response rate was observed between trial participants and nonparticipants. This can be viewed both as a weakness in our sample and as a substantive finding, in that individuals who declined to participate in the clinical trial were also more likely to decline to participate in this study. Another limitation is our use of retrospective data, which are constrained in their ability to capture dynamic, �on-the-spot� aspects of decision making. Furthermore, because the data are cross-sectional, they preclude inferences of causality.
	In sum, the study enables valuable insights into decisions about enrollment in a preventive clinical trial. Participants, relative to nonparticipants, approach the decision differently, manage the process differently, and experience the outcomes of their choice differently. Efforts to solve the problem of accrual should be informed by this multidimensional perspective on decision making.
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	3. Fagerlin A, Dillard AJ, Smith DM, et al. Women's interest in taking tamoxifen and raloxifene for breast cancer prevention: response to a tailored decision aid. Breast cancer research and treatment: 681-688, 2011.
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	23. Biedrzycki, BA: Decision making for cancer clinical trial participation: A systematic review. Onc Nursing Forum 37: E387-E399, 2010.
Acknowledgments:  This work is supported in part by the Susan G. Komen for the Cure grant KG081632.









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