Horizons Chronic Graft-Versus-Host-Disease Study

NCT06160986 | Active Not Recruiting

• 1 other identifier: 20230656
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Vs Host Disease; Coping Skills; Quality of Life; Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (3)

• Percentage of participant enrollment

  Participant enrollment will be demonstrated if ≥50% eligible participants enroll

  Baseline (pre-intervention) to 10-week follow-up

• Percentage of participant attendance

  Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions

  Baseline (pre-intervention) to 10-week follow-up

• Percentage of participant retention

  Participant retention will be demonstrated if ≥80% participants are retained in the study at week 10.

  Baseline (pre-intervention) to 10-week follow-up

Study Arms (1)

Horizons Group

EXPERIMENTAL

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

Behavioral: Horizons Group Intervention

Interventions

Horizons Group Intervention BEHAVIORAL

The Horizons Group intervention in English or Spanish language (per participant preference) contains 8 weekly group sessions delivered via video conference by a bone marrow transplant clinician and behavioral health specialist, over approximately 8 weeks, approximately 1.5 hours per session every week. The intervention pairs state-of-the-science information about survivorship and chronic graft versus host disease with self-management strategies. Intervention sessions will be delivered via video conference (Zoom), which participants may access by computer, laptop, tablet, or smart phone. As part of the intervention, participants will have access to an intervention manual and audio-recorded relaxation exercises to support learning and skills practice.

Horizons Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Lara Traeger, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 27, 2023
• Primary Completion: December 12, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)