RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: City of Hope Medical Center • ClinicalTrials.gov ID: NCT07733141

Registry updated: 2026-10-16

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Biospecimen Collection (Procedure)
Undergo blood sample collection
Mindfulness Relaxation (Behavioral)
Complete group mindfulness sessions
Mindfulness Relaxation (Behavioral)
Complete individual mindfulness session
Mindfulness Relaxation (Behavioral)
Complete daily self meditation
Survey Administration (Other)
Ancillary studies

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)

Conditions

Chronic Graft Versus Host Disease Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Locations

City of Hope Medical Center — Duarte, California, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment