Offering a financial reimbursement program (FRP) during therapeutic clinical trial (TCT) discussions was feasible in encouraging a diverse patient population to consider trial participation. These findings, from a pilot randomized clinical trial, were published in JCO Oncology Practice.
The lack of patient diversity in clinical trials remains a problem in cancer research. Despite widespread acknowledgement of this, little research has been done on ways to mitigate the issue. The Improving Patient Access to Cancer Clinical Trials (IMPACT) study aimed at assessing the feasibility of an FRP intervention with or without a follow-up phone call to improve diversity in clinical trial enrollment. At 2 National Cancer Institute comprehensive cancer centers (CCCs), 170 patients with a cancer diagnosis were approached about participating in an FRP during TCT a discussion from April 2019 to September 2019. Patients were randomly assigned 1:1 to receive usual care (given a brochure) or usual care plus the intervention (contacted by follow-up telephone call).
Most approached patients consented to enroll in the study (78%). Those who declined to participate were not interested or knew they would not qualify for the FRP.
Among the 132 patients who signed the IMPACT consent form, 67 were not eligible for the clinical trial (51%) or were not eligible for the FRP (11%). The proportion of patients who ultimately participated in TCTs did not differ between the cohorts (70% vs 70%).
Patients who participated were mean age 57 years (standard deviation, 14), 57% were women, 49% White, 26% Hispanic, 12% Asian, and 5% Black. The most common diagnoses were gastrointestinal (36%), breast (24%), and genitourinary (17%) cancers. Income was reported by 50% of participants, and most were in the lowest household income brackets: earning less than $25,000 (24%) or $25,000 to $55,999 (14%) annually.
This study may have included selection bias for patients already seeking cancer care at the CCCs.
These data indicated that an FRP intervention at CCCs was feasible and associated with high TCT enrollment overall but the telephone call did not increase participation.
Borno HT, Zhang L, Zhang S, et al. Implementation of a multisite financial reimbursement program in cancer clinical trials integrated with patient navigation: a pilot randomized clinical trial. JCO Oncol Pract. Published online February 23, 2022. doi:10.1200/OP.21.00328