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

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.

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.

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.