Multidisciplinary Intervention In Chronic GVHD

Mass General Brigham

Status: Active, not recruiting

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

Treatments: Behavioral: Usual Care; Behavioral: Horizon Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04479995

19-772

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Horizon Program

Experimental group

Description:

Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes. Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions

Treatment:

Behavioral: Horizon Program

Usual Care

Experimental group

Description:

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

Treatment:

Behavioral: Usual Care