Multidisciplinary Intervention In Chronic GVHD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD

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

Intervention / Treatment
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* Behavioral: Horizon Program
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Horizon Program<br>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<br>* Telehealth videoconferencing sessions and questionnaires.<br>|
| Experimental: Usual Care<br>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<br>* Standard medical visits with additional paper or electronic booklet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Enrollment | Feasibility will be demonstrated if ≥50% eligible participants enroll | Baseline (pre-randomization) to 8 week follow up | 
| Rate of adherence | Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions | Baseline (pre-randomization) to 8 week follow up | 
| Rate of retention | Feasibility will be demonstrated if 80% of participants remain in study | Baseline (pre-randomization) to 8 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) | We will use linear mixed models to investigate longitudinal differences in quality of life between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life). | Baseline (pre-randomization) up to 16 week follow up | 
| Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD) | We will use linear mixed models to investigate longitudinal differences in symptom burden between study groups (Lee cGVHD score range 0-56, with higher scores indicating worse symptom burden). | Baseline (pre-randomization) up to 16 week follow up | 
| Psychological Distress: Hospital Anxiety and Depression Scale (HADS) | We will use linear mixed models to investigate longitudinal differences in psychological distress between study groups (HADS score range 0-21, with higher scores indicating greater distress). | Baseline (pre-randomization) up to 16 week follow up | 
| Medical Adherence: Medication Adherence Report Scale (MARS-5) | We will use linear mixed models to investigate longitudinal differences in medical adherence self management between study groups (MARS-5 score range 5-25, with higher scores indicating greater adherence). | Baseline (pre-randomization) up to 16 week follow up | 
| Social Support: Medical Outcomes Study Social Support Survey (MOS SSS) | We will use linear mixed models to investigate longitudinal differences in social support self management between study groups (MOS SSS score range 0-100, with higher scores indicating greater support). | Baseline (pre-randomization) up to 16 week follow up | 
| Self-Efficacy: Cancer Self-Efficacy Scale (CASE) | We will use linear mixed models to investigate longitudinal differences in cancer self-efficacy between study groups (CASE score range 0-170, with higher scores indicating greater self-efficacy). | Baseline (pre-randomization) up to 16 week follow up | 
| Coping Skills: Measure of Current Status (MOCS) | Using to compare Coping Skills self management target between study groups We will use linear mixed models to investigate longitudinal differences in coping skills between study groups (CASE score range 0-52, with higher scores indicating greater coping skill). | Baseline (pre-randomization) up to 16 week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cell Transplant Complications, Graft Vs Host Disease, Coping Skills, Quality of Life