Factors that Influence a Woman's Decision to Enroll in Breast Cancer Clinical Trials – Implications on How to Improve Minority Enrollment and Retention

Abstract

<h3>Purpose/Objective(s)</h3> Black women with breast cancer often present with more advanced and aggressive disease when compared to White women, resulting in a relative increased risk of mortality. Despite this disparity, Black women remain severely underrepresented in breast cancer clinical trials. We aimed to characterize the important psychosocial factors that influence a woman's decision to enroll in a radiation oncology clinical trial. <h3>Materials/Methods</h3> With IRB approval, a questionnaire adapted from two pre-validated surveys investigating psychosocial factors influencing clinical trial enrollment was administered to women with curable breast cancer treated with radiation therapy at four different sites within a university medical system where all patients are screened for clinical trial eligibility and offered enrollment. Eligible participants were administered the survey during a single follow-up visit. Chi-square tests and a Mann-Whitney U test were used to assess associations or differences between the populations. <h3>Results</h3> From August 2020-February 2022, 148 women completed the survey, the majority of which were located at community sites (77%) and were diagnosed with early-stage disease (I:57%; II:32%). Over half (58%) of the women were employed, had some collegiate-level education (82%) and the median income of the entire cohort was $98,845. Thirty-six women (24.3%) self-identified as being Black. When compared to non-Black (predominantly White, 70%) patients, Black women had a lower median income (p<0.001) and a lower median Charlson Comorbidity Index (CCI; p=0.024). On the survey, Black women reported they were less likely to have been asked to participate in a clinical trial (p=0.005), were more likely to agree with statements regarding research harming minorities (p<0.001), hiding information from participants (p=0.024) or research providing unwanted health information (p<0.001). In this patient population, religious beliefs have an important influence in Black women choosing to participate in a clinical trial when compared to White women (p=0.002). <h3>Conclusion</h3> This data suggests a level of distrust among Black women against research that may hinder enrollment into clinical trials. We are further characterizing these important factors through focus groups, with a goal of designing interventions to help with clinical trial recruitment, particularly in patients of color.