Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Compliance (feasibility)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Compliance (feasibility)
Time Frame: 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)
- Feasibility of daily meditation in patients with a diagnosis of cGVHD(Up to 8 weeks)
- 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)
- Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria(From baseline to completion of MBI program, up to 8 weeks)