Factors related to enrollment in the breast cancer prevention trial at a comprehensive cancer center during the first year of recruitment.

Background: Using an a priori theoretic model of behavior change, factors predicting enrollment in a randomized chemoprevention trial during the first year of recruitment were assessed prospectively.

Methods: Eligible participants were asked to complete a 90-item semistructured questionnaire after attendance at an informational meeting. Components of the Health Belief Model (including perceived susceptibility, perceived severity, perceived benefits and barriers, cues to action, and health motivation), health status, preventive health behaviors, and social influence were assessed in relation to enrollment.

Results: Overall, 331 women attended one of the meetings, and 73% completed a questionnaire; 45% enrolled on the trial and 55% did not. In bivariate analyses, all but one of the perceived barriers were associated negatively with enrollment; however, items assessing perceived susceptibility, perceived severity, and perceived benefits were not. Nonparticipants also were more likely to be over 49 years of age, to be currently or to have been on estrogen replacement therapy, and to have had hot flashes. In logistic regression analysis, not being able to take estrogen replacement therapy was the strongest predictor of nonparticipation (odds ratio [OR], 12.13, 95% confidence interval [CI], 3.63, 40.60). Other factors associated with nonparticipation were concern about side effects of tamoxifen (OR, 5.06; CI, 2.37, 10.80); the possibility of getting a placebo (OR, 7.75; CI, 1.51, 39.67); the costs associated with the trial (OR, 3.21; CI, 1.12, 9.24); and absence of concern that significant others would be reassured if the respondent was taking tamoxifen (OR, 2.58; CI, 1.04, 6.41).

Conclusions: These findings support the view that recruitment efforts for chemoprevention trials should address barriers specific to their circumstances. In addition, increasing the support available from personal social networks may enhance recruitment to chemoprevention trials for breast cancer.