Multidisciplinary Intervention In Chronic GVHD

NCT ID: NCT04479995

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-02

Study Completion Date

2027-12-01

Brief Summary

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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).

Detailed Description

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This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding of chronic GVHD and treatment, coping, and quality of life.

Randomization means that participants will be put into one of two groups by chance:

* Horizons Program

--Individuals who receive the Horizons Program will attend 8 weekly 90-minute group sessions using a secure TeleHealth videoconferencing system
* Usual care --Individuals who receive usual care will also receive an educational booklet.

The research study procedures include:

* screening for eligibility
* a brief test of videoconferencing software
* completion of three study assessments (after signing consent but before randomization and at 8 weeks and 16 weeks after the start of the Horizons Program)
* Individuals who receive usual care will also receive an educational booklet. It is anticipated 80 people will take part in this research study.

The MGH BMT Survivorship Program is supporting this research study by providing funding for this project.

Conditions

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Stem Cell Transplant Complications Graft Vs Host Disease Coping Skills Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Horizon Program

Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes.

Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions

Group Type EXPERIMENTAL

Horizon Program

Intervention Type BEHAVIORAL

Telehealth videoconferencing sessions and questionnaires.

Usual Care

Standard 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

Group Type EXPERIMENTAL

Usual Care

Intervention Type BEHAVIORAL

Standard medical visits with additional paper or electronic booklet.

Interventions

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Horizon Program

Telehealth videoconferencing sessions and questionnaires.

Intervention Type BEHAVIORAL

Usual Care

Standard medical visits with additional paper or electronic booklet.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39814942 (View on PubMed)

Other Identifiers

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19-772

Identifier Type: -

Identifier Source: org_study_id

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