DISCO App: Study Protocol for a Randomized Controlled Trial to Test the Effectiveness of a Patient Intervention to Reduce the Financial Burden of Cancer In a Diverse Patient Population
Abstract Background: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30-50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are <65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently1-4. Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups. Methods: Patients diagnosed with breast, lung, colorectal or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, Michigan will be randomized to intervention or usual care arms. Intervention patients will receive the DISCO App before the second interaction with their oncologist, and some patients will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status, etc.) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions, and at 1, 3, 6 and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. Discussion: If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity. Trial registration: Clinicaltrials.gov - NCT04766190. Registered February 23, 2021