Financial toxicity (FT) describes the burden patients face from out-of-pocket costs related to medical care. FT is strongly associated with quality of life and may predict survival. Both direct costs of care and indirect costs such as transportation, child/family care, or lost income may contribute to FT. Patients with low socioeconomic status (SES) and/or members of minority groups (eg, ethnic, racial, religious, linguistic) may be particularly vulnerable to FT. This study aims to measure the change in patient-reported FT (PRFT) during breast cancer treatment among a diverse patient population.
This is a single-arm, single-institution, longitudinal, noninterventional, prospective cohort survey study of patients undergoing curative-intent breast cancer treatment at Maimonides Cancer Center (MMC), a safety-net hospital in Brooklyn, New York, serving a diverse population, with over 45% of MMC patients having Medicaid or no insurance.
Data collection tools include the Comprehensive Score for Financial Toxicity (COST) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) QLQ-C30 questionnaires. Questionnaires are available in English, Arabic, Cantonese, Mandarin, Russian, and Spanish. Patients complete questionnaires prior to beginning curative-intent breast cancer therapy and repeat them 6 months later, with optional completion at 3, 9, and 12 months after enrollment. At 6 months, we will also ask patients “What do you think would help you feel better about the costs of your treatment?”
The primary objective is to evaluate change in PRFT (measured by COST) during breast cancer therapy. Secondary objectives will evaluate correlations between PRFT and outcomes such as missed appointments, hospitalization rates, and survival. We will also evaluate the predictive value of characteristics such as age, gender, primary language, insurance status, SES, cancer stage, and treatment modalities on PRFT. We hypothesize that PRFT will significantly worsen over the initial 6 months of curative-intent treatment for breast cancer.
The study is institutional review board-approved and currently enrolling patients. As of December 15, 2023, 10 patients have been enrolled out of a target of 123. Once complete, this study will measure changes in PRFT among our target population and generate hypotheses on the causes and effects of FT to inform the design of future studies into interventions to ameliorate FT and improve outcomes.