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

PRIMARY OBJECTIVE:

I. Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner/patient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).

SECONDARY OBJECTIVES:

I. Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.

II. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.

III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.

EXPLORATORY OBJECTIVE:

I. Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.

OUTLINE:

Patients complete group sessions once weekly (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.

• Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection: Undergo blood sample collection
• Mindfulness Relaxation (Behavioral), also known as MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction: Complete group mindfulness sessions
• Mindfulness Relaxation (Behavioral), also known as MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction: Complete individual mindfulness session
• Mindfulness Relaxation (Behavioral), also known as MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction: Complete daily self meditation
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Compliance (feasibility) [Up to 8 weeks]: 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.

Secondary outcomes

• Reason for not starting study activities after signing consent [Up to 8 weeks]: 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 [Up to 8 weeks]: 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 [From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks]: 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 [From baseline to completion of MBI program, up to 8 weeks]: 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

Sex: All, ages: 18 Years to any

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)

• Amandeep Salhotra, Principal investigator, City of Hope Medical Center

NIH grants: P30CA033572