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OpenTrials
Active, Not Recruiting

NCT Number: NCT06160986

Horizons Chronic Graft-Versus-Host-Disease Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Graft vs Host Disease Coping Skills Immune System Diseases Quality of Life Stem Cell Transplant Complications

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of participant enrollment

    Time frame: Baseline (pre-intervention) to 10-week follow-up

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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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