Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
City of Hope Medical Center
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.
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. III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD. EXPLOR…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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)/…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- BehavioralMindfulness Relaxation
Complete group mindfulness sessions
- BehavioralMindfulness Relaxation
Complete individual mindfulness session
- BehavioralMindfulness Relaxation
Complete daily self meditation
- OtherSurvey Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California