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

NCT ID: NCT04605211

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2022-09-30

Brief 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.

Detailed 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.

Conditions

Myeloproliferative Neoplasm; Chronic Phase Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Being Present (Supportive Care)

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.

Group Type: EXPERIMENTAL

Online Mindfulness Meditation

Intervention Type: BEHAVIORAL

Complete online audio-based mindfulness meditation exercises

Internet-Based Webinars

Intervention Type: OTHER

Attend webinars

Interventions

Online Mindfulness Meditation

Complete online audio-based mindfulness meditation exercises

Intervention Type: BEHAVIORAL

Internet-Based Webinars

Attend webinars

Intervention Type: OTHER

Other Intervention Names

Online MBSR; Online Mindful Meditation; Web-Based Mindfulness Meditation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Society of Hematology

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Schoenbeck, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2020-07364

Identifier Type: REGISTRY

Identifier Source: secondary_id

202510

Identifier Type: -

Identifier Source: org_study_id