Financial toxicity among patients engaged in clinical research: Prevalence, disparities, and variation by study type.

Abstract

34 Background: Financial toxicity (FT), defined as the objective and subjective financial burden of cancer care, is associated with worse quality of life, decreased treatment adherence, and increased mortality. Although clinical research participation is an essential component of oncology care, racial, ethnic, language, and socioeconomic disparities in enrollment persist, and financial concerns represent an important barrier to participation. We evaluated the prevalence and distribution of FT among patients enrolled in different categories of oncology clinical research protocols. Methods: We conducted a retrospective review of a quality improvement project using routine FT screening data at our institution from March 2023 to December 2024. Patients receiving outpatient oncology care were screened using the COST tool and health-related social risk (HRSR) measures. Research protocol enrollment was categorized as genetics/specimen banking, therapeutic, diagnostic, epidemiologic, or quality-of-life. Baseline FT assessments were defined as screening completed within 3 months prior to consent through 1 week after enrollment. FT was defined as any of the following: COST score <16, unmet essential need (food, housing, medication, or transportation), or borrowing/loans related to cancer care. Results: Among 33,672 screened patients, 5,070 consented to a single research protocol, and 1,629 completed a baseline FT survey within the enrollment timeframe. Overall, 37% of research participants experienced FT at baseline, with similar rates among respective protocol types, including genetics/specimen banking (37%), therapeutic (40%), diagnostic (38%), quality-of-life studies (32%), and epidemiologic (8%) (overall p=0.2). Marked disparities were observed across sociodemographic groups in this cohort: FT affected 57% of Black patients, 42% of Asian patients, and 32% of White patients; patients whose primary language was not English had higher FT rates than English-speaking patients (59% vs 36%); FT was also higher among Medicaid beneficiaries (71%) and dual Medicaid/Medicare enrollees (69%) versus patients with commercial insurance (33%); (all p<0.001). Conclusions: FT is common among oncology clinical research participants, affecting more than one-third of patients at study enrollment. Persistent racial, language, and insurance-related disparities in FT among enrolled research participants highlight ongoing structural inequities affecting patients engaged in clinical research. Routine FT screening at trial enrollment may help identify vulnerable patients and support targeted interventions to improve equitable access to clinical trials.