Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Transplant Complications | — | UNRESOLVED | — |
| Graft-versus-Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HORIZONS Intervention | Behavioral | — | UNRESOLVED |
| Minimally enhanced usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HORIZONS intervention
- 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
- interventionNames
- Behavioral: HORIZONS Intervention
- type
- ACTIVE_COMPARATOR
- label
- Minimally enhanced usual care
- 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
- interventionNames
- Behavioral: Minimally enhanced usual care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available