Psychosocial factors that influence a woman's decision to enroll in a clinical trial – implications on how to improve clinical trial enrollment among Black women

ABSTRACT

Purpose

Black women with breast cancer often present with more aggressive disease when compared to other races, contributing to an increased risk of cancer mortality. Despite this inequity, Black women remain severely underrepresented in breast cancer clinical trials. We aim to characterize factors that influence a woman's decision to enroll in a clinical trial, with the goal of identifying clinical interventions to aid in the recruitment of vulnerable groups.

Methods and materials

A cross-sectional, descriptive study was conducted using a questionnaire adapted from two pre-validated surveys investigating factors influencing clinical trial enrollment. The survey was administered to women with curable breast cancer during a single follow-up visit at four different sites within a university medical system where all patients are screened for clinical trial eligibility. Chi-square tests and Mann-Whitney U test were used to assess associations or differences between the populations.

Results

One hundred ninety-four out of 209 women completed the survey, giving a compliance rate of 93%. Twenty-six percent of women self-identified as Black, most women were located at community sites (67.1%), diagnosed with early-stage disease (I: 57.7%, II: 29.4%), and 81% of women had some collegiate level education. Black women were younger at diagnosis (p=0.005), less likely to be married (p=0.012), but more often lived with family members (p=0.003) and had a lower median income (p<0.001). On the survey, Black women were less likely to trust their care team (p=0.032), more likely to believe that research ultimately harms minorities (p<0.001) and had a stronger belief in God's will determining illness and wellness (p<0.001). Recurring themes of trust in the healthcare team, patient education and advancement of cancer treatments were discussed in the focus groups.

Conclusion

Failure to offer clinical trials and mistrust in research institutions may pose the greatest hindrances to the enrollment of Black women on to clinical trials. Empowering women through education and fostering trustworthy relationships can encourage greater clinical trial participation.