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

20 Participants Needed

Trial Summary

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

The research highlights the importance of social support and coping strategies in improving quality of life and reducing psychological distress in patients with graft-versus-host disease. Group therapy, like the Horizons Group Intervention, may provide social support and help patients develop effective coping strategies, potentially improving their overall well-being. ^{1 2 3 4 5}

How does group therapy differ from other treatments for graft-versus-host disease?

Group therapy for graft-versus-host disease is unique because it focuses on providing social support and psychological coping strategies, which are crucial for improving quality of life and managing the emotional and psychological challenges associated with the condition. Unlike traditional medical treatments that target physical symptoms, group therapy addresses the mental and emotional well-being of patients, helping them to better adhere to healthcare recommendations and reduce distress. ^{1 3 6 7 8}

What is the purpose of this trial?

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 with chronic graft-versus-host disease.

Research Team

Lara Traeger, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

What else do I need to worry about when treating graft-versus-host disease? [2022]

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

Quality of Life in the Chronic GVHD Consortium Cohort: Lessons Learned and the Long Road Ahead. [2018]

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

Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors. [2022]

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

Coping and Modifiable Psychosocial Factors are Associated with Mood and Quality of Life in Patients with Chronic Graft-versus-Host Disease. [2020]

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

Health-related quality of life in patients with steroid-refractory acute graft-versus-host disease. [2023]

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

Ancillary therapy and supportive care of chronic graft-versus-host disease: national institutes of health consensus development project on criteria for clinical trials in chronic Graft-versus-host disease: V. Ancillary Therapy and Supportive Care Working Group Report. [2007]

7. Germany pubmed.ncbi.nlm.nih.gov

[Second Survey on Patient-centred Care of Ocular Graft-versus-Host Disease in Germany]. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Allogeneic hematopoietic stem cell transplantation and treatment with CAR-T cells - identification of psycho-social vulnerability factors: Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)]. [2023]