Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease

Not Applicable

Not yet recruiting

• Conditions: Bone Marrow Transplant Complications; Graft-versus-Host Disease

• Registration Number: NCT06910969
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Start: 2025-06-01
• Primary Completion: 2029-06-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire	10 weeks	Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL

Secondary Outcome Measures

Name	Time	Method
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire	Up to 18 weeks post enrollment	Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)	Up to 18 weeks post enrollment	Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms
Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)	Up to 18 weeks post enrollment	Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse depression symptoms.
Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale	Up to 18 weeks post enrollment	Compare chronic graft versus host disease symptoms as measured by the Lee Symptom Scale. The Lee Symptom Scale ranges from 0 -100 with higher scores indicating worse symptomatology

Trial Locations

Locations (2)

University of Miami Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States