Multidisciplinary Intervention In Chronic GVHD

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04479995
• Other study ID #: 19-772
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Horizon Program
Telehealth videoconferencing sessions and questionnaires.
• Usual Care
Standard medical visits with additional paper or electronic booklet.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Enrollment	Feasibility will be demonstrated if =50% eligible participants enroll	Baseline (pre-randomization) to 8 week follow up
Primary	Rate of adherence	Feasibility will be demonstrated if 80% complete =4 of 8 sessions	Baseline (pre-randomization) to 8 week follow up
Primary	Rate of retention	Feasibility will be demonstrated if 80% of participants remain in study	Baseline (pre-randomization) to 8 week follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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