Coping Skills, Graft Vs Host Disease, Quality of Life, Stem Cell Transplant Complications
Conditions
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.
Interventions
BEHAVIORALHorizons 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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participant enrollment | Baseline (pre-intervention) to 10-week follow-up | Participant enrollment will be demonstrated if ≥50% eligible participants enroll |
| Percentage of participant attendance | Baseline (pre-intervention) to 10-week follow-up | Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions |
| Percentage of participant retention | Baseline (pre-intervention) to 10-week follow-up | Participant retention will be demonstrated if ≥80% participants are retained in the study at week 10. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLara Traeger, PhD
University of Miami
Outcome results
None listed