Utilization of a multisite financial reimbursement program to promote racial/ethnic diversity and inclusion in therapeutic cancer clinical trials: The iMPACT Study.

Abstract

85 Background: A lack of racial/ethnic diversity among cancer therapeutic clinical trial (TCT) participants remains a critical problem. The significance of costs, both direct and indirect, associated with cancer TCT participation are increasingly understood. Here, we report findings observed in the IMproving Patient Access to Cancer clinical Trials (IMPACT) study, a pilot feasibility study investigating the feasibility and efficacy of offering a financial reimbursement program (FRP) during cancer TCT discussion with or without additional outreach in improving enrollment and diversity. Methods: Participants for this study were recruited at two Comprehensive Cancer Centers (CCCs) from April to September 2019. Patients were randomized 1:1 to receive a brochure about a FRP at time of consent for a TCT or receive brochure and outreach through a scripted follow-up phone call regarding the FRP. Results: No difference in TCT enrollment was observed between study arms. Among 170 patients approached to participate, 132 (78%) provided consent. The participant mean age was 57 years old (std dev = 14 years). Among participants 57% were male and 49% were white. The remaining major racial/ethnic groups were Black (5%) Asian (13%) and Hispanic (26%). The proportion of non-whites was greater among IMPACT study (43%) compared to CCC TCT (28%) participants. Among FRP participants, 24% reported a household income < $25,000 and 14% from $25,001 to $56,000. Conclusions: This study observed that offering an FRP as part of TCT discussion is feasible and effective at CCCs. An outreach phone call is not required in order to influence enrollment in TCT. FRP recipients are racially/ethnically diverse and low socioeconomic status.