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

a study on Myeloproliferative Neoplasms Leukemia Chronic Myeloid Leukemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Kelly Schoenbeck, MD
Headshot of Kelly Schoenbeck
Kelly Schoenbeck

Description

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.

Official Title

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

Details

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.

Keywords

Myeloproliferative Neoplasm, Chronic Phase Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, BCR-ABL-Negative, Distress Reduction, Tyrosine Kinase Inhibitors, Leukemia, Myeloid Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase, Myeloproliferative Disorders, Online Mindfulness Meditation, Internet-Based Webinars

Eligibility

You can join if…

Open to people ages 18 years and up

  • PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
  • PATIENT: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
  • PATIENT: Be able to speak and read English
  • PATIENT: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
  • PATIENT: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
  • PATIENT: Be able to provide informed consent
  • CAREGIVER: Be a spouse/partner, other family member, or a close friend of a BCR-ABL-negative patient who consented to participate in the Being Present-MPN study
  • CAREGIVER: Be able to speak and read English
  • CAREGIVER: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
  • CAREGIVER: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
  • CAREGIVER: Be able to provide informed consent

You CAN'T join if...

  • PATIENT: Have had their BCR-ABL-negative MPN transform into acute leukemia
  • PATIENT: Have had their CP-CML transform into blast phase
  • PATIENT: Be post-allogeneic stem cell transplantation
  • PATIENT AND CAREGIVER: Have extensive hearing loss such that ability to participate in the study would be impaired

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Kelly Schoenbeck, MD
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04605211
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated
Contact us about this trial