Horizons Chronic Graft-Versus-Host-Disease Study

February 1, 2024 updated by: Lara Traeger, University of Miami

Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Lara Traeger, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Horizons Group
Participants will receive the Horizons Group intervention for up to 8 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participant enrollment
Time Frame: Baseline (pre-intervention) to 10-week follow-up
Participant enrollment will be demonstrated if ≥50% eligible participants enroll
Baseline (pre-intervention) to 10-week follow-up
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
Baseline (pre-intervention) to 10-week follow-up
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.
Baseline (pre-intervention) to 10-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Lara Traeger, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230656

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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