Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease
NCT ID: NCT06910969
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2025-08-13
2030-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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HORIZONS intervention
Participants randomized to HORIZONS plus usual care will complete the following:
* Questionnaires at baseline, and weeks 10 and 18
* Receive the HORIZONS intervention from enrollment and for up to 8 weeks. HORIZONS is an 8-session multidisciplinary, patient-centered intervention that combines medical and psychosocial expertise to enhance self-management and quality of life.
* Receive usual care as determined by their local clinicians
HORIZONS Intervention
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Minimally enhanced usual care
Participants randomized to usual care will complete the following
* Questionnaires at baseline, and weeks 10 and 18 after enrollment
* Receive a standardized booklet containing evidence-based information on chronic GVHD management and HCT survivorship recommendations as well as receive care as determined by their local oncologists
Minimally enhanced usual care
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
Interventions
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HORIZONS Intervention
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Minimally enhanced usual care
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
Eligibility Criteria
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Inclusion Criteria
* 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 a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
18 Years
ALL
No
Sponsors
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University of Miami Sylvester Comprehensive Cancer Center
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
Professor of Medicine
Principal Investigators
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Areej El-Jawahri MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-651
Identifier Type: -
Identifier Source: org_study_id
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