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NCT07733141
Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease
Conditions: Chronic Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 17
Sponsor: City of Hope Medical Center
Location: City of Hope Medical Center Duarte California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative
* Willingness to participate in the study
* Willingness to attend in-person or virtual group sessions
* Ability to read and understand English (required for protocol therapy and planned survey)
* Age: ≥ 18 years
* Confirmed diagnosis of moderate/severe chronic graft-versus-host disease by National Institute of Health (NIH) criteria
* Karnofsky performance status ≥ 80
Exclusion Criteria:
* Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
* An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
* Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
* Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Source: ClinicalTrials.gov (NCT07733141). StuddyBuddy aggregates publicly available trial information.