Recruitment and retention results for a population-based cervical cancer biobehavioral clinical trial

Objective.Minority and low-income cancer patients are underrepresented in clinical trials, contributing to diminished access to state-of-the-art care and disparities in cancer outcomes including survivorship issues. In cervical cancer, there is a disproportionate disease burden among minority and underserved women and persistent quality of life disruption. We encountered significant challenges in both recruitment and retention in a randomized biobehavioral clinical trial for cervical cancer survivors, identified through California Cancer Registries, leading to this investigation.Methods.To determine differential rates of accrual and retention, data from our trial are analyzed using descriptive statistics, logistic regression and multivariate analysis of variance. Ethnic differences in associations between covariables and attrition rates were tested by interaction factors. Process evaluation and focus group data were obtained to inform improvement strategies.Results.Of eligible subjects with viable phone numbers, 29% enrolled and 71% actively or passively refused. Enrolled Hispanic women were more likely to have less education (p < 0.001), lower income (p = 0.003), and more children (p = 0.028). The dropout rate was associated with less education (p = 0.012), foreign-birth (p = 0.061), speaking Spanish in the home (p = 0.012). Reported reasons for active refusal were ‘too busy’ for all women, ‘too emotional’ for non-Hispanic women, ‘too ill’ and phlebotomy for Hispanic women. Subsequent focus groups identified specific strategies to improve study materials.Conclusion.Although population-based recruitment of minority and underserved cancer patients continues to be a challenge, specific sociodemographic and disease variables can predict accrual difficulties. The information herein, taken together with disease and culturally relevant strategies, can be useful when recruiting underserved cancer survivors.

Research Highlights
► Minority and low-income cancer patients are underrepresented in clinical trials.
► Sociodemographic factors can predict accrual & retention in cervical cancer studies.
► Culturally relevant strategies are useful when recruiting minority cancer survivors.