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Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
August 13, 2025
Primary Completion Date
June 1, 2029
Completion Date
February 1, 2030
Last Updated
March 3, 2026
350
ESTIMATED participants
HORIZONS Intervention
BEHAVIORAL
Minimally enhanced usual care
BEHAVIORAL
Lead Sponsor
Massachusetts General Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06660355