Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease (HORIZONS)

Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Marrow Transplant Complications; Graft-versus-Host Disease
• Intervention / Treatment: Behavioral: HORIZONS Intervention; Behavioral: Minimally enhanced usual care

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 Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara Traeger PhD; Phone Number: 304-284-3012; Email: ltraeger@miami.edu
• Study Contact Backup: Name: Areej El-Jawahri MD; Phone Number: 617-721-4000; Email: ael-jawahri@mgb.org

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Sylvester Comprehensive Cancer Center
      • Principal Investigator: Lara Traeger, PhD
      • Contact: Lara Traeger, PhD; Phone Number: 305-243-5302; Email: ltraeger@miami.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Areej El-Jawahri, MD
      • Contact: Areej El-Jawahri; Phone Number: 617-724-4000; Email: ael-jawahri@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HORIZONS intervention; 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	Behavioral: HORIZONS Intervention; Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Active Comparator: Minimally enhanced usual care; 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	Behavioral: Minimally enhanced usual care; Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire	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	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire	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	Up to 18 weeks post enrollment
Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)	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	Up to 18 weeks post enrollment
Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)	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.	Up to 18 weeks post enrollment
Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale	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	Up to 18 weeks post enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of Miami Sylvester Comprehensive Cancer Center
• Investigators: Principal Investigator: Areej El-Jawahri MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: neoplasms by site; neoplasms; hematologic diseases; graft-versus-host disease; hematologic neoplasms
• Additional Relevant MeSH Terms: Immune System Diseases; Hemic and Lymphatic Diseases; Neoplasms; Hematologic Neoplasms; Hematologic Diseases; Graft vs Host Disease; Neoplasms by Site
• Other Study ID Numbers: 24-651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Areej El-Jawahri (ael-jawahri@mgb.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No