Translating Evidence‐Based Self‐Management Interventions Using a Stepped‐Care Approach for Patients With Cancer and Their Caregivers: A Pilot Sequential Multiple Assignment Randomized Trial Design

ABSTRACT Background Self‐directed interventions are cost‐effective for patients with cancer and their family caregivers, but barriers to use can compromise adherence and efficacy. Aim Pilot a Sequential Multiple Assignment Randomized Trial (SMART) to develop a time‐varying dyadic self‐management intervention that follows a stepped‐care approach in providing different types of guidance to optimize the delivery of Coping‐Together, a dyadic self‐directed self‐management intervention. Methods 48 patients with cancer and their caregivers were randomized in Stage 1 to: (a) Coping‐Together (included a workbook and 6 booklets) or (b) Coping‐Together + lay telephone guidance. At 6 weeks, change in distress level was assessed, and non‐responding dyads were re‐randomized in Stage 2 to (a) continue with their Stage 1 intervention or (b) be stepped‐up. Benchmarks for acceptability, feasibility, and clinical significance (anxiety and quality of life (QOL)) were assessed via surveys and study logs. Results Feasibility was supported by a low refusal rate at ≤ 30% and < 10% missing data. Men and women were enrolled in at least a 40:60 ratio for caregivers, but less for patients. Recruitment was slow at 1 dyad/week. Acceptability was supported by a low attrition rate (12.5%) and with 87% of participants finding the booklets helpful. Telephone guidance in Stage 1 increased adherence to Coping‐Together; however, in Stage 1, participants benefited more from the self‐directed format than the guidance. All patients who were stepped‐up in Stage 2 benefited from their new assignment; this trend was less clear for caregivers. Significance Findings suggest a 3‐step approach to dyadic self‐management support that warrants further testing. Trial Registration Clinical Trials Registration #: NCT04255030.