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Background Financial hardship is a growing problem among patients with advanced cancer and their spouse caregivers. Previous studies have shown that the cancer treatment related costs may adversely impact not only patient and caregiver financial status but also quality of life, caregiver burden, treatment adherence, and health care utilization. Financial navigation is a potential solution to help patients and families navigate the cost of cancer care. The goal of this study is to investigate whether a comprehensive oncology financial navigation program will decrease the risk of household financial hardship and lead to improvements in patient and spouse caregiver psychosocial outcomes. Methods We will conduct a randomized controlled trial comparing a financial literacy and navigation program (intervention) to financial literacy training alone (control) in patient and spouse caregiver dyads treated at NCI Community Oncology Research Program (NCORP) sites throughout the United States. The intervention will be administered remotely by our community partners, Consumer Education and Training Services (CENTS) and Patient Advocate Foundation (PAF). Eligible patients will be 18 years or older, English- or Spanish-speaking, and be within 120 days of a metastatic solid tumor or advanced hematologic malignancy diagnosis. Spouse caregivers should also be 18 years or older, be residing within the same household as the patient, and be either legally married or filing taxes as “married filing jointly” with the eligible patient. The intervention will be delivered monthly for 6 months. The primary study outcome is risk of financial hardship, as evidenced in patient and spouse credit reports which are collected at baseline and periodically through 12 months. Additional patient and caregiver outcomes will be assessed using questionnaires administered through 12 months. Discussion This is one of the first randomized studies to assess the impact of a remotely administered financial navigation program on dyadic financial and psychosocial outcomes. If the financial navigation intervention is shown to decrease financial hardship, then financial navigation should be considered a key component of high-quality cancer care. In addition, study findings would underscore the need for policy level changes to mitigate the financial impact of cancer diagnosis. Trial registration : ClinicalTrials.gov Identifier: NCT04960787 |
