Group telehealth program to help adults with chronic graft-versus-host disease
Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
This program tests whether the HORIZONS group telehealth sessions help adults with moderate to severe chronic graft-versus-host disease manage symptoms and improve quality of life compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06910969 on ClinicalTrials.gov |
What this trial studies
HORIZONS is a multidisciplinary, group-based telehealth program designed for adults living with moderate to severe chronic graft-versus-host disease. In this randomized trial, about 350 allogeneic hematopoietic cell transplant survivors will be assigned to HORIZONS plus usual care or to minimally enhanced usual care and followed for up to 18 weeks. The intervention delivers structured group sessions in English or Spanish that target self-management, symptom coping, and psychosocial support. Investigators will measure quality of life, psychosocial distress, and identify barriers and facilitators to implementing HORIZONS.
Who should consider this trial
Good fit: Adults (≥18) who received allogeneic hematopoietic cell transplants, report moderate to severe chronic GVHD, can participate in English or Spanish group telehealth sessions, and do not have active relapsed disease or untreated severe psychiatric/cognitive conditions are ideal candidates.
Not a fit: Patients with only mild cGVHD, active relapsed disease requiring therapy, major untreated psychiatric or cognitive conditions that interfere with consent or participation, or inability to use telehealth are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, HORIZONS could improve symptom self-management, reduce psychosocial distress, and raise quality of life for adults with chronic GVHD while offering a scalable telehealth approach.
How similar studies have performed: Prior psychosocial and self-management programs for HSCT survivors have shown quality-of-life benefits, but group-based telehealth specifically tailored to chronic GVHD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years) who have undergone allogeneic HCT * Have moderate to severe cGVHD based on patient-report * Have ability to participate in English or Spanish language group telehealth intervention. Exclusion Criteria: * Patients with mild cGVHD based on their self-report. * Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent. * Patients with active relapsed disease requiring therapy.
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Areej El-Jawahri MD — Massachusetts General Hospital
- Study coordinator: Lara Traeger PhD
- Email: ltraeger@miami.edu
- Phone: 304-284-3012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.