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

Abstract

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. The Oncologist 2021;9999:• • 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.

Assessment of self-reported financial toxicity among patients with nasopharyngeal carcinoma undergoing radiotherapy: A cross-sectional study in western China

“…Regarding disease characteristics, advanced cancer and receiving targeted therapy are both risk factors for FT. Advanced nasopharyngeal cancer requires more systemic treatments, such as innovative drugs and diagnostic methods, thereby directly increasing the medical costs ( 33 ). Nevertheless, several studies ( 11 , 34 , 35 ) have suggested that indirect medical costs for cancer treatment, such as transportation, accommodation, and time expenditure can also contribute to the FT of cancer survivors, but we did not observe significant association between travelling distance to the hospital and FT levels. The impact of indirect costs is limited probably due to the current convenience in transportation, as well as coverage of high-speed railway and subway in the areas where we conducted our survey.…”

Financial toxicity and psychological distress in adults with cancer: A treatment-based analysis

“…The studies of psychological distress have focused on emotional problems (eg, anxiety, depression) and physical problems (eg, fatigue), and studies on financial toxicity are mostly based on demographic factors such as age, with little attention to treatment-related factors. 18 , 19 , 20 , 21 , 22 The above topics are less frequently researched in China. Approximately 85% of patients choose public hospitals for treatment, and cancer patients prefer high-level public hospitals in China.…”

Implementation of an educational intervention to improve medical student cost awareness: a prospective cohort study

“…Furthermore, existing evidence suggests that increased socioeconomic diversity of the physician workforce improves the quality of patient care; our findings may reflect that diversity among clinical trainees and faculty is associated with greater cost conscicousness and advocacy for patients [ 35 ]. As financial burden disproportionately impacts minority patient populations, ensuring diversity in trainee socioeconomic backgrounds may ultimately help to mitigate outcomes disparities [ 6 , 36 ]. Unfortunately, a significant socioeconomic diversity gap persists in medical education, perpetuated both by substantial increases in the costs of medical school attendance and inherent difficulties in assessing socioeconomic background as a less visible form of diversity in the applications process [ 37 – 39 ].…”