NCT06910969

Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease

Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.

Detailed description

This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease. Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care. Participation in this study is expected to last up to 18 weeks after enrollment. The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.

Conditions

• Bone Marrow Transplant Complications
• Graft-versus-Host Disease

Interventions

Type	Name	Description
BEHAVIORAL	HORIZONS Intervention	Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
BEHAVIORAL	Minimally enhanced usual care	Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations

Timeline

• Start date: 2025-08-13
• Primary completion: 2029-06-01
• Completion: 2030-02-01
• First posted: 2025-04-04
• Last updated: 2026-03-03

Locations

2 sites across 1 country: United States