NCT04479995

Multidisciplinary Intervention In Chronic GVHD

Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).

Detailed description

This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding of chronic GVHD and treatment, coping, and quality of life. Randomization means that participants will be put into one of two groups by chance: * Horizons Program --Individuals who receive the Horizons Program will attend 8 weekly 90-minute group sessions using a secure TeleHealth videoconferencing system * Usual care --Individuals who receive usual care will also receive an educational booklet. The research study procedures include: * screening for eligibility * a brief test of videoconferencing software * completion of three study assessments (after signing consent but before randomization and at 8 weeks and 16 weeks after the start of the Horizons Program) * Individuals who receive usual care will also receive an educational booklet. It is anticipated 80 people will take part in this research study. The MGH BMT Survivorship Program is supporting this research study by providing funding for this project.

Conditions

• Stem Cell Transplant Complications
• Graft Vs Host Disease
• Coping Skills
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Horizon Program	Telehealth videoconferencing sessions and questionnaires.
BEHAVIORAL	Usual Care	Standard medical visits with additional paper or electronic booklet.

Timeline

• Start date: 2020-08-02
• Primary completion: 2022-04-01
• Completion: 2027-12-01
• First posted: 2020-07-21
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States