Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials

The oncologist

article

Ryan W. Huey¹  Vivek Subbiah²  Apostolia M. Tsimberidou²  Shubham Pant²  Timothy A. Yap²  Jordi Rodon²  Funda Meric-Bernstam²  Ya-Chen Tina Shih³  David S. Hong²  Goldy C. George⁴  Penny Phillips⁵  Revenda White⁵  Siqing Fu²  Filip Janku²  Daniel D. Karp²  Aung Naing²  Sarina Piha-Paul² 

[1] Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center;Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center;Department of Health Services Research, The University of Texas MD Anderson Cancer Center;Department of Symptom Research, The University of Texas MD Anderson Cancer Center;Clinical Center for Targeted Therapy, The University of Texas MD Anderson Cancer Center

关键词: Economic burden of disease;    Clinical trials as topic;    Oncology;    Medical;    Clinical trial;    Phase I;    Out-of-pocket costs;   

DOI  :  10.1002/onco.13767

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background Clinical trials are an important therapeutic option for patients with cancer. Although financial burden in cancer treatment is well documented, the financial burden associated with clinical trials is not well understood. Patients and Methods We conducted a survey regarding economic burden and financial toxicity in patients with cancer enrolled in phase I clinical trials for >1 month. Financial toxicity score was assessed using the Comprehensive Score for Financial Toxicity survey. Patients also reported monthly out-of-pocket (OOP) costs. Results Two hundred and thirteen patients completed the survey (72% non-Hispanic White; 45% with annual income ≤$60,000; 50% lived >300 miles from the clinic; 37% required air travel). Forty-eight percent of patients had monthly OOP costs of at least $1,000. Fifty-five percent and 64% of patients reported unanticipated medical and nonmedical expenses, respectively. Worse financial toxicity was associated with yearly household income p = .008), having unanticipated medical costs (OR: 3.2; p = .024), and living >100 miles away from the clinical trial hospital (OR: 2.3; p = .043). Non-White or Hispanic patients (OR: 2.5; p = .011) and patients who were unemployed or not working outside the home (OR: 2.5; p = .016) were more likely to report high unanticipated medical costs. Conclusion Among patients with cancer participating in clinical trials, economic burden is high, and most of patients’ OOP costs were nonmedical costs. Financial toxicity is disproportionally higher in patients with lower income and those who travel farther, and unexpected medical costs were more common among non-White or Hispanic patients. OOP costs can be substantial and are often unexpected for patients. Implications for Practice The financial burden of cancer treatment is well documented, but there are limited data regarding the financial burden associated with cancer clinical trials. This study surveyed 213 patients enrolled in early-phase clinical trials. Monthly out-of-pocket costs were at least $1000 for nearly half of patients. Worse financial toxicity was associated with income

【 授权许可】

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