Protocol for a feasibility trial (EXPRESS-C-GVHD) for an expressive helping intervention within a support group for cutaneous graft-versus-host-disease

Abstract

Background Cutaneous graft-versus-host disease (cuGVHD) is a complication of allogeneic hematopoietic stem cell transplantation that presents with varying severity and can significantly affect one’s quality of life (QOL). No trials have yet tested nonpharmacologic interventions to improve the QOL of patients with cuGVHD. The primary objective of the Expressive Helping in Support Groups for Cutaneous GVHD (EXPRESS-C-GVHD) Trial is to evaluate the effect of a support group that employs expressive writing on cutaneous and systemic GVHD symptoms, general distress, and QOL immediately after the intervention. Secondary objectives include evaluating the impact of the intervention on QOL at 1 month post intervention, as well as willingness to participate, compliance, feasibility, and satisfaction. Methods The EXPRESS-C-GVHD Trial will include patients with chronic cuGVHD who are at least 18 years old and able to use a writing utensil, have access to Zoom, an online video conference platform, and attend all four live support group sessions. Subjects will be recruited from the Department of Dermatology, Northwestern University, Chicago, IL and will participate in a 4-week program via Zoom. Program activities will be 1 hour long and consist of 40 minutes of participant-led verbal reflection and discussion in a group setting in response to prompts, and 20 minutes of expressive writing. Participants will fill out a baseline willingness survey, follow-up surveys after every session, and post-intervention surveys at 2 weeks and 1 month after intervention. Discussion The EXPRESS-C-GVHD Trial is a pilot trial and will assess whether a Zoom-based expressive writing intervention within the framework of a support group is feasible and can improve QOL outcomes among individuals with cuGVHD. Trial Registration The trial is registered under number NCT05694832