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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605211
• Other study ID #: 202510
• Secondary ID: NCI-2020-07364
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• Online Mindfulness Meditation
Complete online audio-based mindfulness meditation exercises

Other:
• Internet-Based Webinars
Attend webinars

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Society of Hematology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Primary Symptoms	The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.	Up to 90 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores	This single-item inventory uses an analog graphic to allow patients to assess their overall distress with a score range of 0 (no distress) to 10 (extreme distress). A score of 4 or higher to differentiate clinically significant distress. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale	The PROMIS anxiety scale is a 8 item scale which measures a participants anxiety based on their response to anxiety related items. Each item response ranges from 1 (never) to 5 (always)Paired t-tests will compare validated survey results. Raw scores ranging from 8 - 40 are converted to scaled scores to determine a standardized anxiety score with higher scores indicating a greater anxiety. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	The EORTC QLQ-C30 has been developed as a quantitative measure of health-related quality of life for use in clinical trials of cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)	The MPN-SAF TSS is 10-item questionnaire is recommended in the NCCN Guidelines for the assessment of symptom burden at baseline and monitoring symptom status during the course of treatment with individual item scores ranging from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)	The EORTC QLQ-CML24 assessment consists of 24 items measuring the following aspects: Symptom Burden, Impact on Daily Life, Impact on Worry/Mood, Body Image Problems, Satisfaction with Care and Satisfaction with Social Life. This scale includes 24 items with responses ranging from a score of 0 (not at all) to 4 (very much). Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC)	The CQOLC is a self-administered scale specifically designed to evaluate cancer patient caregiver quality of life. This scale includes 35 items with responses ranging from a score of 0 (not at all) to 4 (very much). The total possible score is 140, with higher scores representing better quality of life. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Secondary	Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)	The FFMQ-SF assessment measures five facets of mindfulness: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience. The score of each facet is computed by summing the 3 items assigned to the facet which asks the individual to rate which response represents your own opinion of what is generally true for you. Each statement (item) has scores ranging from 1 (never or very rarely true) to 5 (very often or always true), for a total of 15 points per facet. Paired t-tests will compare validated survey results.	Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total