Clinical trial NCT04479995: Multidisciplinary Intervention In Chronic GVHD
Official title: Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stem Cell Transplant Complications
Graft Vs Host Disease
Coping Skills
Quality of Life
Keywords: Stem Cell Transplant Complications
Graft Vs Host Disease
Coping Skills
Quality of Life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Enrollment
timeFrame: Baseline (pre-randomization) to 8 week follow up
measure: Rate of adherence
timeFrame: Baseline (pre-randomization) to 8 week follow up
measure: Rate of retention
timeFrame: Baseline (pre-randomization) to 8 week follow up
Secondary outcomes:
measure: Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Psychological Distress: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Medical Adherence: Medication Adherence Report Scale (MARS-5)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Self-Efficacy: Cancer Self-Efficacy Scale (CASE)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
measure: Coping Skills: Measure of Current Status (MOCS)
timeFrame: Baseline (pre-randomization) up to 16 week follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: