Social Determinants of Health, Disease, and Treatment Related Characteristics of Access Clinical Trial Participants

Disparities exist in clinical trials participation. ACCESS (NCT04904588) is a multi-center, phase II trial primarily to determine overall survival at one year following transplantation of peripheral blood stem cells from mismatched unrelated donors (MMUD) using post-transplantation Cyclophosphamide for patients with hematologic malignancies. Using MMUD expands access for ethnically diverse (ED) patients to HCT. We sought to understand whether there were disparities in ACCESS participants compared to mismatched unrelated donors from a real-world sample and in the intersectionality of race/ethnicity and social determinants of health (SDOH).This descriptive cross-sectional study included all adult enrollees in ACCESS and in the CIBMTR Protocol for the Collection of Patient Reported Outcomes Data (PRO Protocol) who had unrelated donor HCT between 2020 to date. We described and compared baseline SDOH [including COmprehensive Score for financial Toxicity (COST) and Social Vulnerability Index (SVI)], disease, and treatment characteristics of ACCESS and PRO protocol enrollees and between ED and non-ED ACCESS enrollees. ED enrollees were defined as all races other than non-Hispanic Whites. COST is a 12-item measure evaluating financial hardship producing a score ranging from 0-44 validated among cancer patients with lower scores indicating more financial hardship. SVI is a 15-item measure assessing where vulnerable populations exist producing a score from 0-1 with higher values showing greater vulnerability. Kruskal-Wallis test and Pearson chi-square test were used to determine statistically significant differences between groups (defined as <0.05).153 ACCESS and 60 PRO adult participants were analyzed. Of ACCESS enrollees, 73 (47%) were ED and 74 (48%) non-ED (5%= not reported) from 21 and 20 centers, respectively. Compared to patients enrolled on the PRO protocol, ACCESS participants were significantly younger (59 v. 65 years), lower educational attainment (26% v. 7%), lower personal income (21% v. 37%), and closer to transplant centers (28 miles v. 48miles) (Table 2). Within the ACCESS patients, the ED patients were significantly younger (55 v. 64 years), experienced more financial toxicity (22 v. 29.5) and higher social vulnerability (53% v. 18%) (Table 3).Our findings revealed that ACCESS and PRO protocol enrollees differ significantly on specific SDOH, disease, and treatment characteristics and within ACCESS clinical trial, access to HCT is not only expanded to ED patients, but also to those with additional social vulnerabilities compared to those reported to CIBMTR database. These PRO data add significant additional context to that routinely collected in the clinical trial setting. Additional value is added by comparing them to registry patients receiving standard of care transplants. Future analyses will explore outcomes related to these factors.