Abstract

Abstract Background: Out-of-pocket (OOP) costs for TCT participation place an undue burden on many patients particularly patients of low socioeconomic status and are a significant root cause of inequitable access to trials. OOP cost may contribute to the historically low minority participation in TCT of only ~ 5%. Broad diversity in TCT is central in identifying racial/ethnic response to new and novel therapies. LCF has undertaken specific efforts to determine best practices for identifying, engaging, evaluating, and efficiently reimbursing OOP TCT costs such as lodging, ground transportation, and airfare. The original program, Lazarex CARE (LC), is an unstructured nationwide FRP enrolling patients by self-referral or healthcare professional referral. LCF recently initiated IMPACT (Improving Patient Access to Cancer Clinical Trials), a structured institutionally based FRP program, to assess if consistent, culturally appropriate, and intentional interactions at the institutional level will further increase enrollment, retention, and diversity among underserved patients in TCT and assess additional social and cultural barriers to TCT participation. Methods: LC and IMPACT FRPs utilized criteria for reimbursement on a sliding scale of up to seven times the US Federal Poverty Guidelines for patients enrolled in a TCT. Data was analyzed for LC over the period 2015-2020 and for IMPACT at UCSF and USC Norris Comprehensive Cancer Centers (CCC’s) over the period January 2018 through August 2020. Results: From January 2015 through August 2020, LC enrolled 1,614 patients and observed 25% minority participation; Black/AA 8%, Latino/Hispanic 12%, Asian 4%, Multi-ethnic 1%, vs. ~5% nationwide. Additionally, 31% of patients reported household income of <$25,000. Comparison of IMPACT patients (n=377) with LC patients (n=655) from January 2018 – August 2020, indicates higher overall minority participation (63% vs 23%) and lower household income (52% less than $25,000 vs 25%). Minority participation was Black/AA 4%, Latino/Hispanic 42%, Asian 14%, Multi-ethnic 1% for IMPACT and Black/AA 10%, Latino/Hispanic 8%, Asian 3%, Multi- ethnic 1% for LC. Conclusions: While racial/ethnic diversity will be dependent upon local catchment areas this preliminary data suggests that more intentional, structured interactions at the institutional level through IMPACT and the use of culturally appropriate facilitators may have a significant influence on enrollment, retention, and diversity for some of the most understudied and underserved populations. IMPACT is expanding to CCC’s with catchment areas that have a higher percentage of Black/AA to identify causes of lower enrollment for Black/AA and increase TCT participation. Both LC and IMPACT data support the conclusion that universal implementation of reimbursement of OOP costs for TCT participation is fundamental to removing a significant barrier to equitable access and to increasing TCT diversity. Citation Format: Dana L. Dornsife, Hala Borno, Darcy Spicer, Robert G. Johnson. Lazarex Cancer Foundation (LCF) financial reimbursement programs (FRP) promote equitable access and inclusion among racial/ethnic minorities in therapeutic cancer clinical trials (TCT) [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-276.

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