Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
University of Miami Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Lara Traeger PhD
ltraeger@miami.edu
304-284-3012
Backup
Areej El-Jawahri MD
ael-jawahri@mgb.org
617-721-4000
Time Frame
Start Date: 2025-08-13
Estimated Completion Date: 2030-02-01
Participants
Target number of participants: 350
Treatments
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: University of Miami Sylvester Comprehensive Cancer Center