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

This article was originally published here

Oncologist. 2021 Mar 29. doi: 10.1002/onco.13767. Online ahead of print.


BACKGROUND: Clinical trials are an important therapeutic option for cancer patients. 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 cancer patients enrolled in Phase I clinical trials for >1 month. Financial Toxicity Score (FTS) was assessed using the Comprehensive Score for Financial Toxicity (COST) survey. Patients also reported monthly out-of-pocket (OOP) costs.

RESULTS: 213 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). 48% of patients had monthly OOP costs of at least $1000. 55% and 64% of patients reported unanticipated medical and non-medical expenses, respectively. Worse financial toxicity was associated with yearly household income <$60,000 (OR: 2.7, P=0.008), having unanticipated medical costs (OR: 3.2, P=0.024), and living >100 miles away from the clinical trial hospital (OR: 2.3, P=0.043). Nonwhite or Hispanic patients (OR: 2.5, P=0.011) and patients who were unemployed or not working outside the home (OR: 2.5, P=0.016) were more likely to report high unanticipated medical costs.

CONCLUSION: Among cancer patients participating in clinical trials, economic burden is high, and most of patients’ OOP costs were non-medical costs. Financial toxicity is disproportionally higher in patients with lower income and those who travel farther, and unexpected medical costs were more common among nonwhite 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 is limited data regarding the financial burden associated with cancer clinical trials. We surveyed 213 patients enrolled on early-phase clinical trials. Monthly out-of-pocket non-medical expenses were $1,075 and medical expenses were $475. Worse financial toxicity was associated with income <$60,000 and living farther away from the hospital. Racial/ethnic minorities had higher rates of unanticipated medical costs. These data help to quantify the high financial burden for patients and may reveal a cause of disparities in clinical trial enrollment for underrepresented populations.

PMID:33783054 | DOI:10.1002/onco.13767