Design and implementation of a study assessing financial outcomes in cancer patients and their informal caregivers

From the Hutchison Institute for Cancer Outcomes Research (HICOR) and Southwest Oncology Group (SWOG) Statistics & Data Management Center at Fred Hutch

Current literature suggests that cancer patients who endure financial hardships are at greater risk for poorer quality of life, worse survival, and more intense end of life care. A term has been coined to describe a spectrum of financial hardships that cancer patients experience -- "financial toxicity."  Caregivers of cancer patients may have difficulty performing duties such as medication management and outpatient symptom assessment because of the depletion of shared household assets, out-of-pocket spending, and limited income. There is a lack of understanding regarding financial hardship in newly diagnosed cancer patients. This is because many patients are ashamed, overwhelmed, and fear lesser treatment because of their debt or poor credit.  A recent prospective study from investigators in HICOR and SWOG (Public Health Sciences), led by Dr. Veena Shankaran, focused on cancer patients and the caregiver experience and was recently published in Contemporary Clinical Trials.

The prospective study assessed the financial outcomes in patients with metastatic colorectal cancer (mCRC) and their caregivers at multiple points over 12 months. Over the past decade, multiple drugs have been approved for mCRC. Because study patients are seen and treated at community practices, this study (the first national cooperative group-led study) presented a unique opportunity to address financial hardship in cancer patients.

Patients completed financial questionnaires every 3 months and caregivers completed The Caregiver Strain Index, a validated survey of cancer caregiver burden every six months. The patients’ credit reports at baseline and 12 months were linked with clinical and financial questionnaire data. Credit reports represent an objective measurement of financial status that can change over time. According to the investigators, "credit status may correlate with psychosocial distress in patients with cancer and other health conditions." The study team partnered with TransUnion, a credit report agency, to obtain individuals’ credit scores. A secure file transfer protocol (FTP) site was created to obtain credit reports. The goal was to obtain 320 eligible patients over 3 years of enrollment. Factors that influence financial hardship will be adjusted for in a multivariate logistic regression analysis to determine the association between baseline characteristics and self-reported financial hardship. There were initial concerns about accrual and the ability to collect complicated and sensitive information from patients and caregivers. One potential barrier was physician and research coordinator discomfort while discussing the purpose of the study to participants. Nonetheless, a total of 380 patients were enrolled across 120 sites by early 2019. An estimated 40% of patients had a caregiver who concurrently participated (n=152). Credit reports were obtained on about 80% of enrolled patients. Importantly, there was also strong minority and low-income patient representation in the study.

Preliminary study results, presented at ASCO 2020, show that financial hardship (at least one of the following: accrual of debt, income decline of 20% or more, selling/refinancing primary home, or taking out loans to pay for cancer treatment) accumulates progressively over time -- by 12 months, nearly 75% of enrolled patients experienced some form of financial hardship, despite access to health insurance. "Our findings suggest that financial hardship is pervasive. Clinical and policy interventions are needed to protect cancer patients from financial devastation during and after treatment," said Dr. Shankaran. Additional analyses are in progress and will be reported in the coming months.

This study is groundbreaking in nature. According to the authors, "this study prioritized financial toxicity as a major survivorship issue for patients and caregivers." More work should be done to address barriers to prevent patients, physicians, and oncology practices from communicating about financial hardships and cost of care. Once these barriers are fully understood by provider groups, families in hardship can be given resources and treatment decision-making aids. 

This research was supported in part by a Conquer Cancer Foundation Career Development Award, SWOG Hope Foundation Charles Coltman Jr. Award, and the National Cancer Institute.

UW/Fred Hutch Cancer Consortium member Veena Shankaran, Joseph M. Unger, and Scott D. Ramsey contributed to this work.

Shankaran V, Unger JM, Darke AK, Hershman DL, Ramsey SD. Design, data linkage, and implementation considerations in the first cooperative group led study assessing financial outcomes in cancer patients and their informal caregivers. Contemporary Clinical Trials. 2020 May 30:106037.