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.
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)
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
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Mindfulness Relaxation
BehavioralComplete group mindfulness sessions
Mindfulness Relaxation
BehavioralComplete individual mindfulness session
Mindfulness Relaxation
BehavioralComplete daily self meditation
Survey Administration
Other interventionAncillary studies
Compliance (feasibility)
Feasibility is defined as 12 or more of 15 evaluable participants meet compliance criteria. Compliance for each participant will be a binary endpoint (yes versus no). If a participant completes 5/7 group sessions, the practitioner/patient 1:1 session, and end of treatment assessments, compliance is defined as yes. Will be summarized using the percentage and 90% confidence intervals.
Reason for not starting study activities after signing consent
For participants who withdraw consent before starting group sessions or do not attend any of the planned group sessions, the reason for not starting study activities after signing consent will be recorded for each patient
Feasibility of daily meditation in patients with a diagnosis of cGVHD
Feasibility of daily meditation will be assessed weekly and will be defined as 4/7 days per week in which the participant logged at least 15 minutes of individual meditation
Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS
Participants will self-report the level of distress they experienced in the previous week for each of the 28-items on a scale of 0 to 4, with 0 representing "not at all", 1 "slightly", 2 "moderately", 3 "quite a bit", and 4 "extremely". Items will be added to create a total score, which can range from 0 to 100, with a higher score indicating a higher overall symptom burden
Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria
Decrease of one full organ stage (e.g., Stage 1 to Stage 2), or a clear functional change like a 2-point P-ROM score shift per 2014 NIH consensus cGVHD grading criteria
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
