Group Therapy for Graft-versus-Host Disease

Overseen By Milan Pasic, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Cognitive impairment, Prisoners, Pregnant women, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new group therapy program to improve the quality of life for people with chronic graft-versus-host disease, a condition where donated cells attack the patient's body after a stem cell transplant. The therapy, called the Horizons Group Intervention, will be offered for up to 8 weeks and aims to support patients emotionally and mentally. Ideal candidates for this trial have undergone a stem cell transplant, experience moderate to severe symptoms, and receive care at the Sylvester Comprehensive Cancer Center. Participants must feel comfortable in a group setting and speak either English or Spanish.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emotional and mental support for similar patients.

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

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

What prior data suggests that this group-based behavioral intervention is safe for patients with chronic graft-versus-host disease?

Research shows that the Horizons Group Intervention, a program where people meet in groups, is being studied to help those with chronic graft-versus-host disease (GVHD). Studies have found that joining a group like Horizons is manageable for patients and may improve their quality of life.

Available data does not report any harmful side effects from participating in this type of group program, suggesting that patients tolerate it well. Since the program focuses on behavior rather than medication, it emphasizes coping skills and support, which usually have fewer safety concerns.

In summary, current research indicates that the Horizons Group Intervention appears safe. Participants are likely to find it manageable and beneficial for their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Horizons Group Intervention for graft-versus-host disease (GVHD) because it uses a unique group therapy approach. Unlike standard treatments that often rely on immunosuppressive drugs to manage symptoms, this intervention focuses on psychological support to improve patients' emotional well-being and coping strategies. The novelty of this method lies in its potential to enhance quality of life and complement existing medical treatments by addressing the mental health aspects of living with GVHD.

What evidence suggests that the Horizons Group Intervention is effective for enhancing quality of life in patients with chronic graft-versus-host disease?

Research has shown that the Horizons Group Intervention, which participants in this trial will receive, could benefit people with chronic graft-versus-host disease (GVHD). Earlier studies found that joining this group program can enhance quality of life and improve mood. Participants reported feeling less isolated in their challenges when part of a group. The program teaches coping skills to help manage the emotional and mental effects of living with chronic GVHD. While more research is needed, early results suggest it may improve overall well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Lara Traeger, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for patients who had a stem cell transplant and are now dealing with moderate to severe chronic graft-versus-host disease. They must be getting care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program and able to join group sessions in English or Spanish. Pregnant women, prisoners, or those with conditions that affect understanding or participation are excluded.

Inclusion Criteria

I have moderate to severe chronic graft versus host disease.

I can participate in group activities in English or Spanish.

I am currently a patient at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Horizons Group intervention

8 weeks

8 sessions (group-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Horizons Group Intervention

Trial Overview The Horizons Program, a group-based behavioral intervention designed to improve life quality for patients suffering from chronic graft-versus-host disease after stem cell transplantation, is being tested for its practicality.

How Is the Trial Designed?

Group I: Horizons Group Experimental Treatment 1 Intervention

Participants will receive the Horizons Group intervention for up to 8 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39814942/

perceptions of a group coping skills intervention in patients ... "They knew the same struggles": perceptions of a group coping skills intervention in patients with chronic graft-versus-host disease · Authors.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06160986

Horizons Chronic Graft-Versus-Host-Disease Study | ... This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38394783/

Group Coping Intervention in Patients With Chronic Graft ... Conclusions: Participation in a multidisciplinary group intervention study was feasible for patients with chronic GVHD, with promising signals for improving QoL ...

4. jnccn.org jnccn.org/abstract/journals/jnccn/22/1/article-p34.xml

Group Coping Intervention in Patients With Chronic Graft ... Participation in a multidisciplinary group intervention study was feasible for patients with chronic GVHD, with promising signals for improving QoL and mood.

5. 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 ...

6. 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 ...

7. 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 ...