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

University of California, San Francisco47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of Primary Symptoms

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to 16 weeks

Secondary Outcomes

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.