A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors

Chronic Myeloid Leukemia Clinical Trial

Official title: Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors

Status Completed

Clinical Trial Summary

This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.

Clinical Trial 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 tyrosine kinase inhibitors (TKIs), and CP-CML patients in treatment-free remission (TFR).

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, CP-CML patients on TKIs, CP-CML patients on TKIs, and CP-CML patients in TFR.

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. ;

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Chronic Phase Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm

• NCT number: NCT04605211
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Completion date: September 30, 2022