Clinical trial NCT04605211: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors
Official title: Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myeloproliferative Neoplasm
Chronic Phase Chronic Myelogenous Leukemia
Chronic Myeloid Leukemia
Keywords: BCR-ABL-Negative
Distress Reduction
Tyrosine Kinase Inhibitors
Leukemia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Society of Hematology
First posted: 2020-10-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Frequency of Primary Symptoms
timeFrame: Up to 90 days
measure: Frequency of Participants' Understanding of Hematologic Malignancies
timeFrame: Up to 90 days
measure: Frequency of Participants' Perception of web-based mindfulness meditation
timeFrame: Up to 90 days
measure: Frequency of Reported Barriers of Web-Based Mindfulness Meditation
timeFrame: Up to 90 days
measure: Percentage of patients approached who consent to participate
timeFrame: Up to 90 days
measure: Frequency of Reasons for Ineligibility
timeFrame: Up to 90 days
measure: Frequency of Reasons for Refusal to Participate
timeFrame: Up to 16 weeks
measure: Frequency of Attrition over time
timeFrame: Up to 16 weeks
measure: Frequency of Attrition Causes
timeFrame: Up to 16 weeks
measure: Frequency of meditation practice
timeFrame: Up to 16 weeks
measure: Median duration of meditation practice
timeFrame: Up to 16 weeks
measure: Frequency of playing recorded webinars
timeFrame: Up to 16 weeks
measure: Duration of playing recorded webinars
timeFrame: Up to 16 weeks
measure: Measure of Acceptability using semi-structured interviews
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC)
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
measure: Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
timeFrame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kelly Schoenbeck, MD
role: PRINCIPAL_INVESTIGATOR
References: