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

NCT06910969 | Recruiting DMC

• 1 other identifier: 24-651
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Graft-versus-Host Disease; Bone Marrow Transplant Complications

Keywords

neoplasms; hematologic diseases; neoplasms by site; hematologic neoplasms; graft-versus-host disease

Outcome Measures

Primary Outcomes (1)

• Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

  Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL

  10 weeks

Secondary Outcomes (4)

• Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

  Up to 18 weeks post enrollment

• Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)

  Up to 18 weeks post enrollment

• Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)

  Up to 18 weeks post enrollment

• Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale

  Up to 18 weeks post enrollment

Study Arms (2)

HORIZONS intervention

EXPERIMENTAL

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

Behavioral: HORIZONS Intervention

Minimally enhanced usual care

ACTIVE COMPARATOR

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

Behavioral: Minimally enhanced usual care

Interventions

HORIZONS Intervention BEHAVIORAL

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

HORIZONS intervention

Minimally enhanced usual care BEHAVIORAL

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

Minimally enhanced usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Miami Sylvester Comprehensive Cancer Center: collaborator

Study Sites (2)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease; Neoplasms; Hematologic Diseases; Neoplasms by Site; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Immune System Diseases; Hemic and Lymphatic Diseases

Study Officials

• Areej El-Jawahri MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Traeger PhD

CONTACT

304-284-3012; ltraeger@miami.edu

Areej El-Jawahri MD

CONTACT

617-721-4000; ael-jawahri@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)