Feasibility, acceptability, and potential effects of a digital oral anticancer agent intervention: A pilot randomized controlled trial protocol (Preprint)

Abstract

BACKGROUND Individuals on oral anticancer agents (OAAs) often face important challenges requiring timely informational support, monitoring, and medication management. OBJECTIVE This study aims to assess the feasibility, acceptability and potential effects of a comprehensive digital OAA intervention. METHODS A 2-arm, mixed-method pilot randomized controlled trial (RCT) is taking place at a large university-affiliated cancer centre in Montreal, Quebec, Canada. Participants (N=52) complete baseline online self-report e-questionnaires, then are randomized to the experimental group (intervention plus usual care, n = 26) or control group (usual care only, n = 26). The study intervention includes: 1) OAA informational videos, 2) OAA-related eHandouts and other supportive resources, 3) nurse-led phone call follow-ups, and 4) e-reminders to take OAAs. Study e-questionnaires are completed once a week for the first month, and every two weeks for subsequent four months, or until OAA treatment is completed. A subset (n = 20) will participate in semi-structured interviews once they complete the study requirements. Study feasibility is assessed using recruitment, retention, and response rates, as well as intervention uptake. Through e-questionnaires and exit interviews, intervention acceptability is assessed prospectively at baseline and retrospectively upon study completion. Potential effects will be assessed via medication adherence self-efficacy, medication adherence self-report, and symptom distress. RESULTS Data collection will be complete December 2023. Results are expected in early 2024. CONCLUSIONS This study relies on a theory-based multimodal OAA digital intervention that is tailored to the needs of participants. Using both quantitative and qualitative data collection approaches enhances insights into study purpose. Following participants over the course of treatment captures potential changes in processes and outcomes. CLINICALTRIAL NCT04984850.