Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease | NCT07733141

NCT07733141

Overview

NCT ID: NCT07733141
Lead Sponsor: City of Hope Medical CenterOTHER
Official Title: Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
Brief 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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)