Clinical trial NCT06910969: Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease
Official title: Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Marrow Transplant Complications
Graft-versus-Host Disease
Keywords: neoplasms
hematologic diseases
neoplasms by site
hematologic neoplasms
graft-versus-host disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Miami Sylvester Comprehensive Cancer Center
First posted: 2025-04-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Primary outcomes:
measure: Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
timeFrame: Up to 18 weeks post enrollment
measure: Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
timeFrame: Up to 18 weeks post enrollment
measure: Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
timeFrame: Up to 18 weeks post enrollment
measure: Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale
timeFrame: Up to 18 weeks post enrollment
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri MD
role: PRINCIPAL_INVESTIGATOR
References: