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Multidisciplinary Intervention for Chronic Graft-versus-Host Disease

This study is testing a program called HORIZONS, which is a group-based telehealth (online video calls) intervention with therapists, to see if it improves the quality of life for adults living with chronic graft-versus-host disease (cGVHD). cGVHD is a complication that can happen after a bone marrow transplant. You would either receive the HORIZONS program, which involves 8 sessions, or a standardized booklet with information on managing cGVHD. The main goal is to see if HORIZONS improves your quality of life after 10 weeks. We are looking for about 350 adults who have had an allogeneic hematopoietic stem cell transplant (a type of bone marrow transplant) and have moderate to severe cGVHD. You must be able to participate in English or Spanish. The study aims to understand how well HORIZONS works and what helps or hinders its use.

Study design
This is a randomized clinical trial involving about 350 adult participants. You would be randomly assigned to one of two groups: the HORIZONS intervention or a group receiving a booklet with information.
What's involved
Participation in this study is expected to last up to 18 weeks after you join. The HORIZONS intervention involves 8 sessions.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured at 10 weeks after joining the study.

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NCT06910969

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

Recruiting
NAAges 18+InterventionalSupportive care
Massachusetts General Hospital
~350 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:HORIZONS InterventionMinimally enhanced usual care

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
Measured over 10 weeks

Conditions

Bone Marrow Transplant Complications
Graft-versus-Host Disease

Explore related trials

Graft Versus Host Disease

Where it's being run

2 sites across 2 states
Florida1
Massachusetts1

Study leadership

  • Areej El-Jawahri MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Lara Traeger PhD
[email protected]
304-284-3012
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire10 weeks

    Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL