RecruitingNot ApplicableNCT06910969

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

Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease


Sponsor

Massachusetts General Hospital

Enrollment

350 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

BEHAVIORALHORIZONS Intervention

Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions

BEHAVIORALMinimally enhanced usual care

Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations


Locations(2)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06910969


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