Print

Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Behavioral: Horizon Program
    Telehealth videoconferencing sessions and questionnaires.
Experimental
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
  • Behavioral: Usual Care
    Standard medical visits with additional paper or electronic booklet.

More Details

Status
Active, not recruiting
Sponsor
Massachusetts General Hospital

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.