Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease (HORIZONS)

Mass General Brigham

Status: Enrolling

Conditions: Bone Marrow Transplant Complications; Graft-versus-Host Disease

Treatments: Behavioral: HORIZONS Intervention; Behavioral: Minimally enhanced usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06910969

24-651

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

HORIZONS intervention

Experimental group

Description:

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

Treatment:

Behavioral: HORIZONS Intervention

Minimally enhanced usual care

Active Comparator group

Description:

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

Treatment:

Behavioral: Minimally enhanced usual care