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

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ClinicalTrials.gov Identifier: NCT04605211
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
American Society of Hematology
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Myeloproliferative Neoplasm Chronic Phase Chronic Myelogenous Leukemia Chronic Myeloid Leukemia Behavioral: Online Mindfulness Meditation Other: Internet-Based Webinars Not Applicable

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 TKIs.

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, and CP-CML patients on TKIs.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: 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.
Behavioral: Online Mindfulness Meditation
Complete online audio-based mindfulness meditation exercises
Other Names:
  • Online MBSR
  • Online Mindful Meditation
  • Web-Based Mindfulness Meditation

Other: Internet-Based Webinars
Attend webinars




Primary Outcome Measures :
  1. Frequency of Primary Symptoms [ Time Frame: Up to 90 days ]
    The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.

  2. Frequency of Participants' Understanding of Hematologic Malignancies [ Time Frame: Up to 90 days ]
    The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.

  3. Frequency of Participants' Perception of web-based mindfulness meditation [ Time Frame: Up to 90 days ]
    The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.

  4. Frequency of Reported Barriers of Web-Based Mindfulness Meditation [ Time Frame: Up to 90 days ]
    The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.

  5. Percentage of patients approached who consent to participate [ Time Frame: Up to 90 days ]
    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.

  6. Frequency of Reasons for Ineligibility [ Time Frame: Up to 90 days ]
    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.

  7. Frequency of Reasons for Refusal to Participate [ Time Frame: Up to 16 weeks ]
    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.

  8. Frequency of Attrition over time [ Time Frame: Up to 16 weeks ]
    The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.

  9. Frequency of Attrition Causes [ Time Frame: Up to 16 weeks ]
    Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.

  10. Frequency of meditation practice [ Time Frame: Up to 16 weeks ]
    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.

  11. Median duration of meditation practice [ Time Frame: Up to 16 weeks ]
    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.

  12. Frequency of playing recorded webinars [ Time Frame: Up to 16 weeks ]
    The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

  13. Duration of playing recorded webinars [ Time Frame: Up to 16 weeks ]
    The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics

  14. Measure of Acceptability using semi-structured interviews [ Time Frame: Up to 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  2. Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  3. Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  4. Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  5. Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24) [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  6. Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC) [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.

  7. Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [ Time Frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
  • PATIENT: CML patients must be actively treated with a TKI during the study period
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605211


Contacts
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Contact: Kate Rafanova (415) 502-4751 Kate.Rafanova@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Kate Rafanova       Kate.Rafanova@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Kelly Schoenbeck, MD         
Sub-Investigator: Chloe Atreya, MD         
Sponsors and Collaborators
University of California, San Francisco
American Society of Hematology
Investigators
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Principal Investigator: Kelly Schoenbeck, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04605211    
Other Study ID Numbers: 202510
NCI-2020-07364 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
BCR-ABL-Negative
Distress Reduction
Tyrosine Kinase Inhibitors
Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases