Horizons Chronic Graft-Versus-Host-Disease Study

Quality of Life Clinical Trial

Official title:

Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06160986
• Other study ID #: 20230656
• Status: Recruiting
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Lara Traeger, PhD
• Phone: 3052843012
• Email: ltraeger[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Coping Skills
• Graft Vs Host Disease
• Quality of Life
• Stem Cell Transplant Complications

Intervention

Behavioral:
• Horizons Group Intervention
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participant enrollment	Participant enrollment will be demonstrated if =50% eligible participants enroll	Baseline (pre-intervention) to 10-week follow-up
Primary	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
Primary	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