Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HORIZONS Intervention, Minimally enhanced usual care.
- Who it may be relevant to
- Registry conditions: Bone Marrow Transplant Complications, Graft-versus-Host Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Overview
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.
Interventions
- Behavioral HORIZONS Intervention
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions - Behavioral Minimally enhanced usual care
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
Primary outcome measures
- Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire [Time frame: 10 weeks]
Secondary outcome measures (4)
- 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- University of Miami Sylvester Comprehensive Cancer Center — Miami
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06910969 · 24-651