Assessing Patient-Reported Financial, Social, and Time Toxicity in Early-Phase Cancer Clinical Trials in Australia Through a Prospective Multicenter Nonrandomized Cohort Study

Abstract

Purpose: Early-phase clinical trials (EP-CTs) provide access to novel therapeutics for patients with limited standard treatment options. Beyond drug-related risks, participants may experience hidden toxicities, including time, financial, and social burdens that often go unmeasured.

Methods: The Patient Experience in Early-Phase Cancer Clinical Trials (PEARLER) study aimed to assess time, financial, and social toxicity (ST) in a prospective, multicenter cohort. Participants completed a time toxicity (TT) survey and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 on day 1 of cycles 1-6. Financial toxicity (FT) was assessed using the EORTC scoring manual; ST was evaluated using the social and role functioning domains. Multilevel models examined trends over time.

Results: A total of 122 participants (median age 62 years, range, 25-83) were enrolled. Median objective TT was 26%. Only 16% (20/122) reported subjective TT, most commonly during cycles 1-2 (85%). FT was reported by 44% (54/122), but did not significantly change over time (P = .136). Although 71% (87/122) reported some reduction in social function, social functioning scores remained stable throughout trial participation. Role functioning declined in participants age 60 years and younger but was maintained in those older than 60 years.

Conclusion: To our knowledge, PEARLER is the first prospective study to assess TT, FT, and ST in Australian EP-CTs. Although objective time burden was measurable, few patients perceived it as problematic beyond early cycles. FT and ST were commonly reported but remained stable over time. These findings suggest that EP-CT participation may not negatively affect patient-reported quality-of-life domains and provide reassurance for both clinicians and patients considering enrollment.