Multidisciplinary Intervention In Chronic GVHD

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Coping Skills; Graft Vs Host Disease; Stem Cell Transplant Complications
• Intervention / Treatment: Behavioral: Horizon Program; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Horizon Program; 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; Telehealth videoconferencing sessions and questionnaires.
Experimental: Usual Care; 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; Standard medical visits with additional paper or electronic booklet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Coping Skills; Graft Vs Host Disease; Stem Cell Transplant Complications
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 19-772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No