Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT07733141
- Status
- Not Yet Recruiting
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Conditions
- Chronic Graft Versus Host Disease
- Hematopoietic and Lymphatic System Neoplasm
- Malignant Solid Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Mindfulness Relaxation — BEHAVIORALComplete group mindfulness sessions
- Mindfulness Relaxation — BEHAVIORALComplete individual mindfulness session
- Mindfulness Relaxation — BEHAVIORALComplete daily self meditation
- Survey Administration — OTHERAncillary studies
Study Details
This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.
Key Dates
- First listed
- Jul 29, 2026
- Start date
- Mar 1, 2027
- Status verified
- Jul 2026
- Primary completion
- Mar 1, 2029
- Completion
- Mar 1, 2029
Study Design
- Enrollment
- 17 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Supportive care (mindfulness based intervention)Patients complete group sessions QW, on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.
Primary Outcome Measure
Compliance (feasibility) [ Time Frame: Up to 8 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Amandeep Salhotra (PRINCIPAL_INVESTIGATOR) |
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