Horizons Chronic Graft-Versus-Host-Disease Study

Study Overview
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Brief Summary
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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.

Official Title
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Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

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

Intervention / Treatment
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* Behavioral: Horizons Group Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Horizons Group<br>Participants will receive the Horizons Group intervention for up to 8 weeks. | Behavioral: Horizons Group Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |