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Assessing Patient-Reported Financial, Social, and Time Toxicity in Early-Phase Cancer Clinical Trials in Australia
Udit Nindra1,2,3,4, Joanne Tang3, Jun Hee Hong3,4
1Department of Medical Oncology, Wollongong Hospital, Wollongong, Australia.
JCO Oncology Practice
|November 3, 2025
Summary
Early-phase clinical trials (EP-CTs) offer novel treatments but can cause time, financial, and social toxicity. The PEARLER study found these burdens were generally stable and did not negatively impact quality of life for most participants.
Area of Science:
- Oncology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Early-phase clinical trials (EP-CTs) provide access to novel therapeutics for patients with limited standard treatment options.
- Participants in EP-CTs may face unmeasured toxicities, including time, financial, and social burdens.
Purpose of the Study:
- To assess time toxicity (TT), financial toxicity (FT), and social toxicity (ST) in a prospective, multicenter cohort of patients in EP-CTs.
- To evaluate the impact of these toxicities on patient quality of life.
Main Methods:
- The Patient Experience in Early-Phase Cancer Clinical Trials (PEARLER) study enrolled 122 participants.
- Participants completed surveys on TT and quality of life (EORTC QLQ-C30) across 6 cycles.
- FT and ST were assessed using EORTC criteria and social/role functioning domains, with multilevel models analyzing trends.
Main Results:
- Median objective TT was 26%, with only 16% reporting subjective TT, primarily in early cycles.
- FT was reported by 44% of participants and remained stable over time.
- Social functioning scores were stable, though role functioning declined in participants aged 60 and younger.
Conclusions:
- PEARLER is the first prospective study to assess TT, FT, and ST in Australian EP-CTs.
- Objective time burden was measurable but perceived as problematic by few beyond early cycles.
- FT and ST were common but stable, suggesting EP-CT participation may not negatively affect patient-reported quality-of-life domains.
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