Coping Skills, Graft Vs Host Disease, Quality of Life, Stem Cell Transplant Complications
Conditions
Keywords
Stem Cell Transplant Complications, Graft Vs Host Disease, Coping Skills, Quality of Life
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: * 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.
Interventions
BEHAVIORALHorizon Program
Telehealth videoconferencing sessions and questionnaires.
BEHAVIORALUsual Care
Standard medical visits with additional paper or electronic booklet.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of retention | Baseline (pre-randomization) to 8 week follow up | Feasibility will be demonstrated if 80% of participants remain in study |
| Rate of Enrollment | Baseline (pre-randomization) to 8 week follow up | Feasibility will be demonstrated if ≥50% eligible participants enroll |
| Rate of adherence | Baseline (pre-randomization) to 8 week follow up | Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Psychological Distress: Hospital Anxiety and Depression Scale (HADS) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Medical Adherence: Medication Adherence Report Scale (MARS-5) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Social Support: Medical Outcomes Study Social Support Survey (MOS SSS) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Self-Efficacy: Cancer Self-Efficacy Scale (CASE) | Baseline (pre-randomization) up to 16 week follow up | 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). |
| Coping Skills: Measure of Current Status (MOCS) | Baseline (pre-randomization) up to 16 week follow up | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAreej El-Jawahri, MD
Massachusetts General Hospital
Outcome results
None listed