Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT04479995
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).
Detailed Description:
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.
Study:
NCT04479995
Study Brief:
Protocol Section:
NCT04479995