Evaluating the impact of financial toxicity among cancer clinical trial participants

Introduction

Cancer precision medicine as part of standard of care (SOC) or clinical trials (CT) requires access to high-cost advanced diagnostics and therapeutics.¹ The difference in out-of-pocket (OOP) costs associated with cancer treatment as part of SOC versus CTs remains limited. This study sought to evaluate the varying financial burden and toxicity among cancer patients receiving treatment at an academic medical center as part of a CT versus SOC.

Methods

Patients presenting to medical oncology clinic at an academic medical center for a new or follow-up visit, who were English-speaking and able to provide informed consent, were approached for a one-time survey from July 2018 to August 2020. Study participants provided demographic, clinical, financial, and patient reported outcomes data.² Financial toxicity was measured using the Comprehensive Score for financial Toxicity (COST) patient reported outcome measure (supplement Table 1).³ The data was summarized using descriptive statistics, with t-tests and Chi-squared tests were performed to identify differences between SOC versus CT participants for continuous and categorical variables, respectively.

Results

As shown in Table 1, a total of 67 participants completed the survey. In the study, CT participants were significantly younger than SOC participants (CT, mean 57 years, SD=13.5; SOC, mean 67, SD=10.7; p=0.002). The mean time since diagnosis was significantly longer among SOC participants at 7.9 years (SD=7.3) compared to CT participants at 2.7 years (SD=3.9) (p=0.001). All study participants had solid tumors, except for 4 CT participants with hematologic malignancies. The majority of participants had metastatic disease (SOC, 78%; CT, 74%). Most participants were non-Hispanic white (SOC, 78%; CT 71%). The household income was significantly higher among SOC participants compared to CT participants, with a larger proportion reporting an income of $100,000 or more (SOC, 52%; CT, 19%; p<0.001). A larger proportion of SOC participants were retired (56%) compared to CT (26%) participants (p=0.01). A significantly higher proportion of CT participants reported OOP cost exceeding $1,000 in the prior 30 days compared to SOC participants (SOC, 8.3%; CT, 16.1%, p<0.001). The estimated monthly OOP cost was $742 (SD=$1214) among CT participants compared to $278 (SD=$370) among SOC participants (p=0.05). Significantly more SOC participants felt very comfortable discussing cost with their cancer doctor compared to CT participants (SOC, 69%; CT, 35%; p=0.02). As shown in Supplement Table 1, a higher level of financial toxicity was observed among CT participants (COST PROM score = 16.86, SD=10.31) compared to SOC participants (COST PROM score = 19.77, SD=4.91) (p=0.03). As shown in Figure 1, the participants insured with Medicare/Medicaid reported similar level of financial toxicity whether they were offered SOC versus enrolled in a CT. However, participants with private insurance enrolled in CTs reported a lower COST score, as compared to SOC participants, indicating higher financial toxicity; due to the small sample, this pattern is purely descriptive.

Figure 1.Boxplots of Financial Toxicity (COST PROM) for Standard of Care versus Clinical Trial participants stratified by insurance type

Discussion

This study observed significantly higher OOP cost and financial toxicity among participants receiving treatment within a CT compared to SOC. These differences in self-reported OOP cost and financial toxicity may be attributed to increased frequency of CT appointments, longer duration of clinic visits, additional CT required labs and scans, or greater distances traveled to CT site.^4–7 Coupled with variable increases in cost-sharing by insurance type, these may contribute to the growing financial burden on patients enrolled in CTs. Despite this observation, CT participants in this study were less likely to feel comfortable bringing up healthcare cost related issues with their cancer doctor.

Conclusion

While this study is limited by a small sample size, large and meaningful differences were identified between the two groups, suggesting that there is a critical need to further examine the added financial toxicity placed on patients receiving cancer treatment in the context of a CT. Given the racial/ethnic disparities observed in oncology CTs,⁸ the financial burden associated with participation must be closely examined and addressed to promote equity in access to CTs.

Conflict of Interest

None

Funding information

HTB and CJR received funding from the Prostate Cancer Foundation. HTB, SZ, and TKL received funding from the Lazarex Cancer Foundation.

Ethical statements

N/A

Acknowledgement

N/A

Author contributions

i. All authors: conception and design,
ii. All authors: data collection and assembly
iii. All authors: data analysis, manuscript writing

All authors have approved the manuscript.