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Horizon Program for Graft-versus-Host Disease

N/A

Waitlist Available

Led By Areej El-Jawahri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with moderate to severe chronic GVHD

Adult patients (≥ 21 years) who underwent allogeneic HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-randomization) up to 16 week follow up

Awards & highlights

Study Summary

This trial is testing whether a new, multidisciplinary approach to care can improve quality of life, symptoms, and psychological distress for people who have developed GVHD after a stem cell transplant.

Who is the study for?

Adults over 21 who had a stem cell transplant, developed moderate to severe chronic GVHD, and are treated at the MGH Blood and Marrow Transplant Clinic. Participants must understand English for group activities. Those with conditions or cognitive impairments that affect consent or participation, as well as prisoners and pregnant women, cannot join.Check my eligibility

What is being tested?

The study compares two approaches: the Horizons Program—a multidisciplinary intervention aimed at improving life quality, reducing symptoms and psychological distress—and usual care given to patients with chronic GVHD after stem cell transplants.See study design

What are the potential side effects?

Since this trial focuses on supportive interventions rather than medications, it does not directly involve drug side effects. However, participants may experience varying levels of emotional discomfort during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe chronic graft-versus-host disease.

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I am 21 or older and have had a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-randomization) up to 16 week follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-randomization) up to 16 week follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-randomization) up to 16 week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Enrollment

Rate of adherence

Rate of retention

Secondary outcome measures

Coping Skills: Measure of Current Status (MOCS)

Medical Adherence: Medication Adherence Report Scale (MARS-5)

Psychological Distress: Hospital Anxiety and Depression Scale (HADS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 Intervention

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

Group II: Horizon ProgramExperimental Treatment1 Intervention

Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes. Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,937 Previous Clinical Trials

13,198,970 Total Patients Enrolled

Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital

18 Previous Clinical Trials

4,432 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the hoped-for results of this experiment?

"This study will span a Baseline period to an 8 week follow up, with the primary evaluation criteria being adherence. Secondary objectives include assessing medical adherence via the Medication Adherence Report Scale (MARS-5), cancer self-efficacy through the Cancer Self-Efficacy Scale (CASE), and coping skills with Measure of Current Status (MOCS). Linear mixed models will be used to compare differences in these areas between groups, as indicated by their respective score range - MARS-5 5-25; CASE 0–170; MOCS 0–52 - where higher scores indicate greater success."

Answered by AI

Is this research project presently recruiting participants?

"According to clinicaltrials.gov, this particular trial is not presently accepting participants. Originally posted on August 2nd 2020 and last updated on the 23rd of August 2022, there are currently 461 other medical studies in need of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multidisciplinary Intervention In Chronic GVHD

El-Jawahri, Areej,M.D. 2020. "Multidisciplinary Intervention In Chronic GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479995.

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