Actively Recruiting
Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Led by Massachusetts General Hospital · Updated on 2026-03-03
350
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
University of Miami Sylvester Comprehensive Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multidisciplinary group-based telehealth program called HORIZONS to improve self-management and quality of life in adults living with chronic graft-versus-host disease after hematopoietic stem cell transplant. The study aims to compare this intervention to minimally enhanced usual care and identify key factors that help or hinder its use. About 350 adults with moderate to severe chronic graft-versus-host disease are expected to participate. Participants will be randomly assigned to one of two groups. One group will receive the HORIZONS intervention, which includes 8 weekly therapist-led sessions combining medical and psychosocial support, alongside their usual care. The other group will receive minimally enhanced usual care, which involves a standardized informational booklet about managing chronic graft-versus-host disease and survivorship recommendations, plus their usual clinical care. The study lasts up to 18 weeks after enrollment. Participants will complete questionnaires at the start, 10 weeks, and 18 weeks to measure quality of life, depression, anxiety, and chronic graft-versus-host disease symptoms. Researchers will monitor how well participants manage their condition and their overall wellbeing throughout the study, aiming to understand the benefits and challenges of the telehealth program.
CONDITIONS
Brief Title
Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older who have undergone allogeneic hematopoietic cell transplant
- Have moderate to severe chronic graft-versus-host disease based on patient report
- Able to participate in English or Spanish language group telehealth intervention
You will not qualify if you...
- Patients with mild chronic graft-versus-host disease based on self-report
- Patients with a major untreated psychiatric or cognitive condition that interferes with informed consent
- Patients with active relapsed disease requiring therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 8 weeks
Participants randomized to the HORIZONS group receive an 8-session multidisciplinary group-based telehealth intervention over 8 weeks, while participants in the usual care group receive a standardized informational booklet and routine care.
8 telehealth sessions or 1 informational booklet distribution visit
Duration - Up to 18 weeks after enrollment
Participants complete questionnaires to assess quality of life, depression, anxiety, and chronic graft-versus-host disease symptoms at baseline, 10 weeks, and 18 weeks after enrollment.
3 assessment visits (baseline, week 10, and week 18)
Trial Site Locations
Total: 2 locations
1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Lara Traeger PhD
A
Areej El-Jawahri MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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