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

NCT04605211 | Completed DMC

• 2 other identifiers: 202510NCI-2020-07364
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

BCR-ABL-Negative; Distress Reduction; Tyrosine Kinase Inhibitors; Leukemia

Outcome Measures

Primary Outcomes (14)

• Frequency of Primary Symptoms

  The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.

  Up to 90 days

• Frequency of Participants' Understanding of Hematologic Malignancies

  The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.

  Up to 90 days

• Frequency of Participants' Perception of web-based mindfulness meditation

  The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.

  Up to 90 days

• Frequency of Reported Barriers of Web-Based Mindfulness Meditation

  The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.

  Up to 90 days

• Percentage of patients approached who consent to participate

  Recruitment rate will be reported as a percentage of all patients who were approached by the study team or medical professional whom consented to participate in the active study.

  Up to 90 days

• Frequency of Reasons for Ineligibility

  For potential study candidates who are ineligible, caregiver relationship and reasons for ineligibility will be collected. Reasons for ineligibility will be reported using descriptive statistics.

  Up to 90 days

• Frequency of Reasons for Refusal to Participate

  For potential study candidates who decide not to participate, caregiver relationship and reasons for refusal will be collected. Reasons for refusal will be reported using descriptive statistics.

  Up to 16 weeks

• Frequency of Attrition over time

  The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.

  Up to 16 weeks

• Frequency of Attrition Causes

  Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.

  Up to 16 weeks

• Frequency of meditation practice

  The study team will call participants and conduct a brief interview to gauge current mindfulness meditation practice. Frequency of mediation will be reported using descriptive statistics.

  Up to 16 weeks

• Median duration of meditation practice

  The study team will call participants and conduct a brief interview to gauge current duration of mindfulness meditation practice. Duration of mediation will be reported using descriptive statistics.

  Up to 16 weeks

• Frequency of playing recorded webinars

  The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

  Up to 16 weeks

• Duration of playing recorded webinars

  The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

  Up to 16 weeks

• Measure of Acceptability using semi-structured interviews

  Information about acceptability and the overall intervention experience will come from semi-structured interviews. Audio recordings of the semi-structured interviews will be professionally transcribed and coded using Atlas.ti for categorizing acceptability using qualitative thematic analysis by at least two investigators.

  Up to 16 weeks

Secondary Outcomes (7)

• Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores

  Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total

• Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total

• Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total

• Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

  Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total

• Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)

  Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total

Study Arms (1)

Being Present (Supportive Care)

EXPERIMENTAL

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.

Behavioral: Online Mindfulness Meditation; Other: Internet-Based Webinars

Interventions

Online Mindfulness Meditation BEHAVIORAL

Complete online audio-based mindfulness meditation exercises

Also known as: Online MBSR, Online Mindful Meditation, Web-Based Mindfulness Meditation

Being Present (Supportive Care)

Internet-Based Webinars OTHER

Attend webinars

Being Present (Supportive Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Society of Hematology: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelly Schoenbeck, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: September 18, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)