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

NCT ID: NCT06910969Sponsor: Massachusetts General HospitalLast updated: 2026-03-03

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.

Detailed description

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.

Arms & 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

Outcome measures

Primary

  • 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

    Time frame: 10 weeks

Secondary

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

    Time frame: Up to 18 weeks post enrollment

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

    Time frame: Up to 18 weeks post enrollment

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

    Time frame: Up to 18 weeks post enrollment

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

    Time frame: Up to 18 weeks post enrollment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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 Criteria: * 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.

Study locations (2)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

Recruiting
Lara Traeger, PhD · Contact
305-243-5302ltraeger@miami.edu
Lara Traeger, PhD · Principal Investigator

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting
Areej El-Jawahri · Contact
617-724-4000ael-jawahri@mgb.org
Areej El-Jawahri, MD · Principal Investigator
Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease | Cancerify