Horizons Chronic Graft-Versus-Host-Disease Study

Not Applicable

Active, not recruiting

• Conditions: Coping Skills; Graft Vs Host Disease; Quality of Life; Stem Cell Transplant Complications
• Interventions: Behavioral: Horizons Group Intervention

• Registration Number: NCT06160986
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Study Start: 2023-12-27
• Primary Completion: 2024-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of participant retention	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	Baseline (pre-intervention) to 10-week follow-up	Participant enrollment will be demonstrated if ≥50% eligible participants enroll
Percentage of participant attendance	Baseline (pre-intervention) to 10-week follow-up	Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States