Multidisciplinary Intervention In Chronic GVHD
1 other identifier
interventional
80
1 country
1
Brief Summary
This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedStudy Start
First participant enrolled
August 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedJanuary 20, 2026
January 1, 2026
1.7 years
July 17, 2020
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of Enrollment
Feasibility will be demonstrated if ≥50% eligible participants enroll
Baseline (pre-randomization) to 8 week follow up
Rate of adherence
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
Baseline (pre-randomization) to 8 week follow up
Rate of retention
Feasibility will be demonstrated if 80% of participants remain in study
Baseline (pre-randomization) to 8 week follow up
Secondary Outcomes (7)
Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Baseline (pre-randomization) up to 16 week follow up
Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)
Baseline (pre-randomization) up to 16 week follow up
Psychological Distress: Hospital Anxiety and Depression Scale (HADS)
Baseline (pre-randomization) up to 16 week follow up
Medical Adherence: Medication Adherence Report Scale (MARS-5)
Baseline (pre-randomization) up to 16 week follow up
Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)
Baseline (pre-randomization) up to 16 week follow up
- +2 more secondary outcomes
Study Arms (2)
Horizon Program
EXPERIMENTALEight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes. Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions
Usual Care
EXPERIMENTALStandard medical visits to address chronic GVHD, with an additional standardized booklet, in electronic or paper format, containing information on the management of chronic GVHD and stem cell transplant survivorship recommendations. Questionnaire assessment at 8 weeks and 16 weeks after Horizons Program group starts
Interventions
Eligibility Criteria
You may qualify if:
- adult patients (≥ 21 years) who underwent allogeneic HCT
- have moderate to severe chronic GVHD
- are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
- have the ability to participate in an English language group intervention
You may not qualify if:
- Patients with comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
- Vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Related Publications (1)
Centracchio JA, Yang DG, Jagielo AD, Greer JA, El-Jawahri A, Traeger L, Nelson AM. "They knew the same struggles": perceptions of a group coping skills intervention in patients with chronic graft-versus-host disease. Support Care Cancer. 2025 Jan 16;33(2):102. doi: 10.1007/s00520-025-09153-x.
PMID: 39814942DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areej El-Jawahri, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 21, 2020
Study Start
August 2, 2020
Primary Completion
April 1, 2022
Study Completion (Estimated)
December 1, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.