Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Rate of retention
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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
Intervention: Horizon Program (Behavioral)
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
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Rate of retention
Time Frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% of participants remain in study
Rate of Enrollment
Time Frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of adherence
Time Frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
Secondary Outcomes
- Medical Adherence: Medication Adherence Report Scale (MARS-5)(Baseline (pre-randomization) up to 16 week follow up)
- Self-Efficacy: Cancer Self-Efficacy Scale (CASE)(Baseline (pre-randomization) up to 16 week follow up)
- Coping Skills: Measure of Current Status (MOCS)(Baseline (pre-randomization) up to 16 week follow up)
- Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)(Baseline (pre-randomization) up to 16 week follow up)
- Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)(Baseline (pre-randomization) up to 16 week follow up)
- Psychological Distress: Hospital Anxiety and Depression Scale (HADS)(Baseline (pre-randomization) up to 16 week follow up)
- Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)(Baseline (pre-randomization) up to 16 week follow up)
Investigators
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital