Financial Toxicity Among Patients With Advanced Solid Tumors Participating in Early-Phase Clinical Trials.

Purpose: Financial toxicity (FT) adversely influences patient quality of life and is a barrier to clinical trial enrollment. Early-phase clinical trials (EPCTs) recruit patients who may have high baseline FT and require additional visits and procedures, potentially increasing FT.

Methods: In this prospective survey study, we sought to assess FT at baseline and after 2 months among patients with advanced solid malignancies participating in EPCTs. Participants were age 18 years and older, were English-speaking, and were treated at the Yale Cancer Center (Yale) and the Tisch Cancer Institute at Mount Sinai (Mount Sinai). At the time of consent and 2 months later, patients completed a sociodemographic questionnaire as well as the 11-item validated Comprehensive Score for Financial Toxicity (COST) instrument. Primary outcomes were baseline COST score and change in COST score from baseline to 2 months. Lower score is associated with higher FT.

Results: One hundred forty-six patients completed survey 1. Mean age was 61.5 years and 50.7% were male. The most common histologies were lung (17.8%), colorectal (16.4%), and breast (12.3%) cancers. Mean baseline COST score was 22.12 (standard deviation, 8.01). FT was associated with being a primary wage earner ( = .044) and inversely associated with age ( = .025). Seventy-one patients completed survey 2. Among 71 patients who completed both surveys, there was no significant difference in COST score between surveys 1 and 2 ( = .28). Race, ethnicity, education, and household income were not associated with baseline COST score or change in FT.

Conclusion: Moderate FT was reported at baseline and on trial among EPCT participants. No change in FT was observed between time points. Additional efforts should be made to decrease FT associated with EPCT participation to maximize access to novel therapies.