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

Part of paid clinical trials in Miami, Florida.

Sponsor
Massachusetts General Hospital
Study ID
NCT06910969
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HORIZONS Intervention — BEHAVIORAL
    Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
  • Minimally enhanced usual care — BEHAVIORAL
    Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
Mar 2026
Primary completion
Jun 1, 2029
Completion
Feb 1, 2030

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire [ Time Frame: 10 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Lara Traeger, PhD
[email protected]
305-243-5302
Lara Traeger, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Areej El-Jawahri
[email protected]
617-724-4000
Areej El-Jawahri, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FLMassachusetts General Hospital· Boston, MA

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