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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Telehealth videoconferencing sessions and questionnaires.
Standard medical visits with additional paper or electronic booklet.
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Rate of Enrollment
Feasibility will be demonstrated if ≥50% eligible participants enroll
Time frame: Baseline (pre-randomization) to 8 week follow up
Rate of adherence
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
Time frame: Baseline (pre-randomization) to 8 week follow up
Rate of retention
Feasibility will be demonstrated if 80% of participants remain in study
Time frame: Baseline (pre-randomization) to 8 week follow up
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (pre-randomization) up to 16 week follow up
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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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (pre-randomization) up to 16 week follow up