Financial and time toxicity among patients with cancer enrolled in pharmacotherapy clinical trials: Systematic reviews.

Abstract

e24053 Background: Financial and time toxicity are increasingly described as burdens of cancer care, yet their magnitude among patients enrolled in pharmacotherapy clinical trials is poorly characterized. We conducted two systematic reviews to quantify the financial and time burdens experienced by cancer trial participants. Methods: We searched MEDLINE, Embase, and CENTRAL (through June 2025) for studies reporting financial or time toxicity among cancer patients enrolled in pharmacotherapy trials. Studies were included if they reported >=1 toxicity outcome. Financial toxicity outcomes included direct medical and indirect non-medical (ie housing, transportation, and lodging) out-of-pocket costs (adjusted to 2025 USD). Time toxicity was defined as days per month with any healthcare contact, including planned (protocol-specified) and unplanned encounters. Data were synthesized descriptively. Results: Three studies reported on financial toxicity, all from the US. Direct expenses ranged from $256–$301/month, while indirect expenses exceeded $828/month, with some patients incurring $3,367–$6,857/month. Total toxicity is multi-fold higher than non-trial participants. Four studies (from Canada, US, Australia and Italy) reported on time toxicity. Patients spent 7.6 days/month in healthcare contact, approximately twice that of non-trial participants. Planned days averaged 2.2/month and unplanned days 2.0/month; the highest burden occurred in the first month of trial enrollment. Higher time toxicity was associated with worse physical function, disease progression, and reduced overall survival. Conclusions: Cancer patients in pharmacotherapy trials experience financial and time burdens, far greater than non-participants. Incorporating standardized measurement and transparent reporting of toxicity into trial design and informed consent can better support equitable participation, improve patient-centered decisions, and guide interventions that meaningfully reduce avoidable burden.