Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Miami
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percentage of participant retention
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •underwent allogeneic hematopoietic stem cell transplant
- •have moderate to severe chronic graft versus host disease
- •currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
- •able to participate in a group intervention in English or Spanish language
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
Arms & Interventions
Horizons Group
Participants will receive the Horizons Group intervention for up to 8 weeks.
Intervention: Horizons Group Intervention (Behavioral)
Outcomes
Primary Outcomes
Percentage of participant retention
Time Frame: Baseline (pre-intervention) to 10-week follow-up
Participant retention will be demonstrated if ≥80% participants are retained in the study at week 10.
Percentage of participant enrollment
Time Frame: Baseline (pre-intervention) to 10-week follow-up
Participant enrollment will be demonstrated if ≥50% eligible participants enroll
Percentage of participant attendance
Time Frame: Baseline (pre-intervention) to 10-week follow-up
Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions
Secondary Outcomes
No secondary outcomes reported
Investigators
Lara Traeger
Associate Professor
University of Miami