Financial Concerns About Participation in Clinical Trials Among Patients With Cancer

Abstract

Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer

“…Minorities are more likely to be underinsured, to seek care at under-resourced hospitals, and to have concerns about the cost of participating in a clinical trial. 29,34 In addition, lack of or inadequate health insurance acts as a barrier to enrollment in clinical trials for several under-represented populations, including racial and ethnic minorities. 29,35 …”

“…33 Similarly, the health care system can also influence patient concerns about the cost of participating in trials and, in turn, their decisions to enroll or not enroll in a clinical trial. 34 Thus, these 2 levels are linked in terms of whether and how health care professionals and minority patients discuss clinical trials and whether minority patients agree to enroll.…”

Relationships Among Financial Distress, Emotional Distress, and Overall Distress in Insured Patients With Cancer

“…If a patient's distress is left unaddressed, it can lead to impaired decision making and poor care selfmanagement. [3][4][5] The rising costs of cancer treatment are increasingly shifted to the patient, which can contribute to financial distress. 6,7 One study found that patients with cancer who experienced unexpected medical costs had increased anxiety and depression and worse quality-of-life (QOL) outcomes over time.…”

Addressing Patients’ Priorities as a Strategy to Improve Value

“…This is particularly important because concerns about treatment-related cost may impact a patient’s ability to make high-quality treatment decisions, such as whether to enroll in a clinical trial [25]. Providers need to be able to guide patients regarding the risks and benefits (including financial toxicity) of alternative treatment options to help them choose treatments that reflect their preferences and values.…”