HORIZONS Telehealth Program for Graft-versus-Host Disease

(HORIZONS Trial)

Recruiting at 1 trial location

Overseen By Lara Traeger PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Mild cGVHD, Untreated psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program called HORIZONS, designed to assist individuals who have undergone a stem cell transplant and are managing chronic graft-versus-host disease (cGVHD). The researchers aim to determine if this program can improve condition management and enhance quality of life compared to standard care. Participants will either engage in this new program alongside their usual care or receive educational materials with their usual care. The trial seeks individuals who have had a stem cell transplant, experience moderate to severe cGVHD, and can participate in English or Spanish group telehealth sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could improve quality of life for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the HORIZONS telehealth program is safe for HSCT survivors?

Research has shown that the HORIZONS program, a telehealth service for individuals with chronic graft-versus-host disease (GVHD), aims to help participants manage their condition more effectively and improve their quality of life. This program integrates various types of support, including medical and psychological assistance.

Although specific safety data for the HORIZONS program is not available, its classification as "Not Applicable" in terms of trial phase suggests a low-risk profile. Programs of this nature, which do not involve new medications, typically focus on providing support rather than introducing treatments with potential safety concerns. Additionally, as a telehealth program, it likely poses no physical risks.

For those considering participation in this trial, it may be reassuring to know that such programs are generally well-received, as they aim to enhance care and support without introducing new medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HORIZONS Telehealth Program for graft-versus-host disease (GVHD) because it offers a unique, multidisciplinary approach that combines medical and psychosocial support to improve self-management and quality of life for patients. Unlike traditional treatments, which typically focus on medication and local clinical care, HORIZONS incorporates an eight-session intervention that leverages telehealth to provide ongoing support and resources directly to patients at home. This approach not only enhances accessibility but also empowers patients with chronic GVHD by integrating comprehensive care into their daily lives, potentially improving outcomes beyond what standard care alone can achieve.

What evidence suggests that the HORIZONS telehealth intervention is effective for improving self-management and quality of life in chronic graft-versus-host disease?

Research has shown that the HORIZONS program, which participants in this trial may receive, might help people with chronic graft-versus-host disease (GVHD) manage symptoms and improve quality of life. Studies have found that approaches involving different types of care, like HORIZONS, can help patients better understand and cope with their condition. Early results suggest that combining medical advice with support for mental and emotional health can help people manage chronic GVHD more effectively. While these findings are encouraging, more research is needed to confirm them. ^{1 2 3 6 7}

Who Is on the Research Team?

Areej El-Jawahri MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults who have had a bone marrow transplant and are now dealing with chronic graft-versus-host disease, which can cause complications like Bronchiolitis Obliterans Syndrome. Participants should be able to manage their condition and participate in telehealth sessions.

Inclusion Criteria

I am 18 or older and have had a stem cell transplant from a donor.

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

I can join group calls in English or Spanish.

Exclusion Criteria

Patients with mild cGVHD based on their self-report

Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believe interferes with the capacity to provide informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HORIZONS intervention for up to 8 weeks, which includes 8 sessions focused on enhancing self-management and quality of life

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, week 10, and week 18

10 weeks

3 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• HORIZONS Intervention

Trial Overview The study is testing a new group-based telehealth program called HORIZONS against the standard care that patients usually receive after a transplant. The goal is to see if HORIZONS helps improve how patients handle their own health and quality of life.

How Is the Trial Designed?

Group I: HORIZONS intervention Experimental Treatment 1 Intervention

Participants randomized to HORIZONS plus usual care will complete the following: * Questionnaires at baseline, and weeks 10 and 18 * Receive the HORIZONS intervention from enrollment and for up to 8 weeks. HORIZONS is an 8-session multidisciplinary, patient-centered intervention that combines medical and psychosocial expertise to enhance self-management and quality of life. * Receive usual care as determined by their local clinicians

Group II: Minimally enhanced usual care Active Control 1 Intervention

Participants randomized to usual care will complete the following * Questionnaires at baseline, and weeks 10 and 18 after enrollment * Receive a standardized booklet containing evidence-based information on chronic GVHD management and HCT survivorship recommendations as well as receive care as determined by their local oncologists

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Miami Sylvester Comprehensive Cancer Center

Collaborator

Trials

11

Recruited

2,700+

Published Research Related to This Trial

Changes in chronic graft-versus-host disease (cGVHD) symptoms, specifically in the eyes, joints, and mouth, from baseline to 6 months can provide insights into longer-term treatment outcomes, but their predictive accuracy is currently insufficient for clinical trials.

The study, which analyzed data from two multicenter observational studies, found that only 45% of patients achieved failure-free survival within two years, highlighting the need for better biomarkers to improve predictions of long-term outcomes in cGVHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Chronic Graft-versus-Host Disease Failure-Free Survival (cGVHD-FFS) Index. Pidala, JA., Hamilton, BK., Martin, PJ., et al.[2021]

In a survey of 1377 allogeneic hematopoietic cell transplant survivors, those with moderate to severe chronic graft-versus-host disease reported significantly worse quality of life and higher symptom burden compared to those whose condition had resolved or who never had it.

A notable percentage (26.7-39.4%) of patients with active chronic graft-versus-host disease were unable to work due to health issues, highlighting the need for improved prevention and treatment strategies to enhance survivorship after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. Lee, SJ., Onstad, L., Chow, EJ., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-bronchiolitis-obliterans-syndrome-5-2025-ef794

HORIZONS Telehealth Program for Graft-versus-Host ... The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04479995

Multidisciplinary Intervention In Chronic GVHD This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11735584/

perceptions of a group coping skills intervention in patients ... Graft-versus-host disease (GVHD) is an inflammatory syndrome that attacks organs in the body and is a major cause of morbidity and impaired ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/590375

Multidisciplinary Intervention for Adults With Chronic Graft- ... The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced ...

5. trial.medpath.com trial.medpath.com/clinical-trial/d99b216648905a4a/nct05690971-randomized-trial-psychosocial-app-chronic-gvhd

Psychosocial Mobile App for Chronic Graft-Versus-Host Disease The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, ...

6. trialx.com trialx.com/clinical-trials/listings/224662/psychosocial-mobile-app-for-chronic-graft-versus-host-disease/

Psychosocial Mobile App for Chronic Graft-Versus-Host ... Overview. The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality ...

7. astctjournal.org astctjournal.org/article/S2666-6367(24)00670-5/fulltext

Establishing a Graft-Versus-Host Disease (GVHD) A telehealth platform with multidisciplinary approach was developed for GVHD care. Female patients had increased visits via telehealth, reducing gender ...