A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myeloid Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients. II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on TKIs...
PRIMARY OBJECTIVES: I. To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients. II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on TKIs. III. To determine the acceptability of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on TKIs. SECONDARY OBJECTIVE: I. To evaluate the preliminary efficacy of the intervention. EXPLORATORY OBJECTIVES: I. To evaluate for differences in the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars: Ia. Based on demographic or clinicopathologic factors. Ib. In patients versus caregivers. II. To evaluate for differences in the preliminary efficacy an 8-week web-based mindfulness meditation program with live webinars: IIa. Based on demographic or clinicopathologic factors. IIb. In BCR-ABL-negative patients versus caregivers. IIc. In BCR-ABL-negative patient-caregiver pairs versus unpaired patients. IId. Based on level of adherence to the practice instructions. OUTLINE: Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week. After completion of study, patients and caregivers are followed up at 8 weeks.
Tracking Information
- NCT #
- NCT04605211
- Collaborators
- American Society of Hematology
- Investigators
- Principal Investigator: Kelly Schoenbeck, MD University of California, San Francisco
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