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Group Therapy for Graft-versus-Host Disease
N/A
Waitlist Available
Led By Lara Traeger, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have moderate to severe chronic graft versus host disease
Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention) to 10-week follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a group therapy program can improve quality of life for people with GvHD.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this study focuses on a behavioral intervention rather than medication, traditional side effects like you'd see with drugs aren't expected. However, participants may experience emotional discomfort discussing their condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe chronic graft versus host disease.
Select...
I am currently a patient at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program.
Select...
I have had a stem cell transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-intervention) to 10-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention) to 10-week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participant attendance
Percentage of participant enrollment
Percentage of participant retention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Horizons GroupExperimental Treatment1 Intervention
Participants will receive the Horizons Group intervention for up to 8 weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments aimed at improving Quality of Life, such as those studied in the Horizons Program, include cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and group-based behavioral interventions. These therapies function by helping patients develop effective coping mechanisms, reduce stress, and improve emotional regulation.
This is essential for Quality of Life patients as it enhances their ability to manage symptoms, boosts mood, and overall well-being, thereby significantly improving their daily functioning and life satisfaction.
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Who is running the clinical trial?
University of MiamiLead Sponsor
950 Previous Clinical Trials
428,373 Total Patients Enrolled
Lara Traeger, PhDPrincipal InvestigatorUniversity of Miami
4 Previous Clinical Trials
423 Total Patients Enrolled