Hybrid-delivered cognitive behavioral symptom management and activity coaching intervention for patients undergoing hematopoietic stem cell transplant: Findings from intervention development and a pilot randomized trial

Abstract

Objective Develop and pilot test a mobile health (mHealth) cognitive behavioral coping skills training and activity coaching protocol (HCT Symptoms and Steps) for hematopoietic stem cell transplant (HCT) patients. Design Two-phase, mixed methods study. Sample HCT patients and healthcare providers. Methods Phase I was patient (n = 5) and provider (n = 1) focus groups and user testing (N = 5) to develop the HCT Symptoms and Steps protocol. Phase II was a pilot randomized trial (N = 40) to evaluate feasibility, acceptability, and pre-to-post outcomes (e.g., physical disability, pain, fatigue, distress, physical activity, symptom self-efficacy) compared to an education control. Findings Qualitative feedback on symptoms, recruitment strategies, coping skills, and mHealth components (e.g., Fitbit, mobile app) were integrated into the protocol. HCT Symptoms and Steps were feasible and acceptable. Pre-post changes suggest physical disability and activity improved while symptoms (e.g., fatigue, distress) decreased. Conclusions HCT Symptoms and Steps have strong feasibility and acceptability and shows promise for benefits. Larger, fully-powered randomized trials are needed to examine intervention efficacy. Implications HCT Symptoms and Steps may reduce physical disability and improve health outcomes post-transplant. Clinical Trial Registration Number NCT03859765