This clinical trial studies ways to improve how patients and oncologists discuss cancer treatment costs through the use of a mobile application, the DISCO app. Information from this study may help researchers better understand how to facilitate discussions between patients and oncologists to reduce the financial burden on patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04766190.
PRIMARY OBJECTIVES:
I. To assess the effectiveness of the DISCO App on short-term outcomes of cost discussion, self-efficacy in managing treatment costs; self-efficacy in physician interactions, and social work/financial navigation (SW/FN) referral between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
II. To assess the effectiveness of the DISCO App on longer-term outcomes of financial toxicity, general adherence, and treatment cost-related adherence between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
SECONDARY OBJECTIVES:
I. To assess the interaction between patient race and the effectiveness of the DISCO App on short-term outcomes of cost discussion, self-efficacy in managing treatment costs, self-efficacy in physician interactions, and SW/FN referral between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
II. To assess the interaction between patient income and the effectiveness of the DISCO App on short-term outcomes of cost discussion, self-efficacy in managing treatment costs, self-efficacy in physician interactions, and SW/FN referral between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
III. To assess the interaction between patient age and the effectiveness of the DISCO App on short-term outcomes of cost discussion, self-efficacy in managing treatment costs, self-efficacy in physician interactions, and SW/FN referral between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
IV. To assess the effectiveness of the DISCO App on short-term outcomes of treatment cost knowledge, perceived financial toxicity, patient active participation, oncologists patient-centered communication, and SW/FN referral uptake between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
V. To assess the interaction between patient race and the effectiveness of the DISCO App on long-term outcomes of financial toxicity, general treatment and clinic appointment adherence, and treatment cost related adherence between patients in the usual care and those in intervention arms (DISCO App and DISCO App + booster).
VI. To assess the effectiveness of the booster on longer-term outcomes of financial toxicity, general treatment and clinic appointment adherence, and treatment cost-related adherence between patients in the usual care and those in each intervention arm (DISCO App and DISCO App + booster).
EXPLORATORY OBJECTIVES:
I. To explore the potential moderators and mediators of the short-term outcomes.
II. To explore the potential moderators and mediators of the longer-term outcomes.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive standard of care.
ARM II: Patients use the DISCO app for 20 minutes viewing a brief educational video followed by a section asking patients to enter their financial information (e.g., employment, insurance status, etc.) and their financial concerns.
ARM III: Patients use the DISCO app as in arm II and receive an email or text message reminder 2 months later about the information viewed in the DISCO app.
After completion of study intervention, patients are followed up at 1, 3, 6, 9, and 12 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorLauren M Hamel