Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Massachusetts General Hospital
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy 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.
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 CenterMiami, Florida
- Massachusetts General HospitalBoston, Massachusetts