Study Results
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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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2020-08-02
2027-12-01
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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
Horizon Program
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
Usual Care
Standard medical visits with additional paper or electronic booklet.
Interventions
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Horizon Program
Telehealth videoconferencing sessions and questionnaires.
Usual Care
Standard medical visits with additional paper or electronic booklet.
Eligibility Criteria
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Inclusion Criteria
* 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
* Vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention
21 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
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
Countries
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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.
Other Identifiers
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19-772
Identifier Type: -
Identifier Source: org_study_id
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