Using SMART design to improve symptom management among cancer patients: A study protocol

Abstract

In this in-progress sequential multiple assignment randomized trial (SMART), dyads of solid tumor cancer patients and their caregivers are initially randomized to 4 weeks of reflexology ormeditative (mindfulness) practices provided by/with their caregiver in the patient's home or to a control group. After 4 weeks, intervention group dyads in which patients do not show improvement in fatigue (non-responders) are re-randomized to either receive additional time with the same therapy during weeks 5-8 or to add the other therapy. The aims are (1) to compare reflexology and meditative practices groups during weeks 1-4 on patients' fatigue severity, summed symptom inventory score, depressive symptoms, and anxiety, so as to determine the relative effectiveness of these therapies and the characteristics of responders and non-responders to each therapy. (2) Among reflexology non-responders based on fatigue score at week 4, to determine patient symptom outcomes when meditative practices are added during weeks 5-8, versus continuing with reflexology alone. (3) Among meditative practices non-responders based on fatigue score at week 4, to determine patient symptom outcomes when reflexology is added during weeks 5-8, versus continuing with meditative practices alone. (4) To compare improvements in patient symptom outcomes among the three groups created by the first randomization. (5) To explore which dyadic characteristics are associated with optimal patient symptom outcomes, to determine tailoring variables for decision rules of future interventions. The trial has a target of 331 dyads post-attrition and has 150 dyads enrolled. We are overcoming challenges with dyadic recruitment and retention while maintaining fidelity.