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

Trial Summary

What is the purpose of this trial?

The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.

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 data supports the effectiveness of the HORIZONS Intervention treatment for graft-versus-host disease?

The research highlights the need for better prevention and treatment of chronic graft-versus-host disease to improve quality of life and survivorship, suggesting that interventions like the HORIZONS Telehealth Program could be beneficial. Although specific data on the HORIZONS Intervention is not provided, the studies emphasize the importance of managing symptoms and improving patient outcomes, which telehealth programs can potentially address. ^{1 2 3 4 5}

How does the HORIZONS Intervention treatment for graft-versus-host disease differ from other treatments?

The HORIZONS Intervention is unique because it uses telehealth videoconferencing to manage symptoms and treatment compliance for patients who are geographically remote, allowing them to receive care in their home communities rather than traveling frequently to a hospital. ^{2 4 6 7 8}

Research Team

Areej El-Jawahri MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Chronic Graft-versus-Host Disease Failure-Free Survival (cGVHD-FFS) Index. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Predicting chronic GVHD outcomes: are we there yet? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors for Permanent Discontinuation of Systemic Immunosuppression in Severely Affected Chronic Graft-Versus-Host Disease Patients. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Patient-reported symptom burden of chronic graft versus host disease: a systematic literature review. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

E-Clinic: an innovative approach to complex symptom management for allogeneic blood and stem cell transplant patients. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

Oral chronic GVHD outcomes and resource utilization: a subanalysis from the chronic GVHD consortium. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and staging of chronic graft-versus-host disease in the clinical practice. [2011]