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

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.