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The Feasibility of Delivering Consumer-based Meditation Applications to Myeloproliferative Neoplasm Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726944
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Huberty, Arizona State University

Brief Summary:

This study was a four-group randomized pilot trial in myeloproliferative neoplasm (MPN) patients. Patients were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into one of four groups, two of which received varying orders of two consumer-based apps (unnamed consumer-based [CB] app and Calm App) and two that received one of the apps alone for the second four weeks of the eight week intervention after an educational control condition. Participants were asked to perform 10 min/day of smartphone-based meditation irrespective of the app and/or the order in which they received the apps. Feasibility outcomes were measured at week five and nine with an online survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. The purpose of this study was to examine the feasibility of the use of two different consumer-based meditation smartphone applications (i.e., apps) in MPN patients.

Specific aim #1: Examine the feasibility of daily meditation delivered using a consumer-based mobile app. Hypothesis: It will feasible to deliver smartphone-based meditation to MPN patients.

Exploratory Aim: Explore the preliminary effects of daily meditation delivered using a consumer-based mobile app on MPN self-report fatigue, anxiety, depression, pain intensity, sleep disturbance, sexual function, global health, quality of life, and total symptom burden. Hypothesis: There will be demonstrated preliminary effects on patient-reported outcomes in MPN patients.


Condition or disease Intervention/treatment Phase
Myeloproliferative Neoplasm Behavioral: Calm App Meditation Behavioral: Unnamed Consumer-Based App Meditation Other: Educational Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study was a 4-group randomized trial design in which participants were randomly assigned to 4 unique groups that lasted for 8 weeks in total. Each group received two 4-week conditions involving one of three different conditions/arms.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Using a Consumer-based Mobile App to Improve Fatigue and Emotional Symptoms in Myeloproliferative Neoplasm Patients
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1 - Meditation1+Meditation2
8 weeks in total; 4 weeks of unnamed consumer-based meditation app + 4 weeks of Calm meditation app
Behavioral: Calm App Meditation
The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.

Behavioral: Unnamed Consumer-Based App Meditation
The unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app.

Group 2 - Meditation2+Meditation1
8 weeks in total; 4 weeks of Calm meditation app + 4 weeks of unnamed consumer-based meditation app
Behavioral: Calm App Meditation
The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.

Behavioral: Unnamed Consumer-Based App Meditation
The unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app.

Group 3 - Control+Meditation1
8 weeks in total; 4 weeks of educational control + 4 weeks of unnamed consumer-based meditation app
Behavioral: Unnamed Consumer-Based App Meditation
The unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app.

Other: Educational Control
The educational control consisted of an educational handout that was provided to participants. This control lasted for 4 weeks.

Group 4 - Control+Meditation2
8 weeks in total; 4 weeks of educational control + 4 weeks of Calm meditation app
Behavioral: Calm App Meditation
The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.

Other: Educational Control
The educational control consisted of an educational handout that was provided to participants. This control lasted for 4 weeks.




Primary Outcome Measures :
  1. Acceptability of Intervention: survey [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    Acceptability was measured with a satisfaction survey. Benchmarks for acceptability included ≥70% response to the following questions in the survey: 1) satisfaction with the apps' content, 2) intending to continue using the app, 3) enjoying using the apps, and 4) recommending it for other MPN patients. The % of participants indicating responses to the four prior questions will be considered "acceptable" if all four questions are responded to with a ≥70% response rate.

  2. Demand of Meditation [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    Demand was measured using adherence to the meditation intervention. Meditation participation was tracked by the smartphone app developers and reported to the Principal Investigator. Adherence benchmarks were defined as an average of ≥49 min/week of meditation across all participants (i.e., ≥70% of prescribed meditation).

  3. Limited-Efficacy Testing of Meditation [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    Limited-efficacy testing was measured with Cohen's d effect sizes calculated for patient-reported outcomes (described below as secondary outcomes).


Secondary Outcome Measures :
  1. MPN Total Symptom Burden (severity and symptomology) [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    A 10-item, validated form that calculates total symptom burden score (MPN Symptom Assessment Form Total Symptom Score). A higher score indicates a worse MPN-specific symptom burden; scores range from 0-100

  2. Fatigue [ Time Frame: Change from Baseline to Week 5 and Change from Baseline to Week 9 ]
    A single-item fatigue question taken from the MPN Symptom Assessment Form; scores can range from 0-10

  3. Anxiety [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Anxiety Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 36.3-82.7

  4. Depression [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Depression Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 41.0-79.4

  5. Sleep Disturbance [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Sleep Disturbance Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 32.0-73.3

  6. Sexual Function [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Sexual Function consisting of five sub-scales; these scales consist of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; the five sub-scales include vaginal discomfort (score range of 33.2-77.08), lubrication (score range of 30.99-69.26), erectile function (score range of 30.72-68.47), satisfaction with sex life (score range of 29.59-72.01), and interest in sexual activity (score range of 32.02-76.17)

  7. Pain Intensity [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Pain Intensity Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 30.7-71.8

  8. Global Health [ Time Frame: Change from Baseline to Week 5 and Week 9 ]
    National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Global Health consisting of Physical Health and Mental Health sub-scales; these scales consist of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; score ranges for physical health are 16.2-67.7 and score ranges for mental health are 21.1-67.6



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • had a diagnosis of MPN (i.e., essential thrombocythemia, polycythemia vera, or myelofibrosis) identified by treating physician
  • owned a mobile smartphone and were willing to download and use a meditation app (i.e., CB or Calm)
  • could read and understand English
  • were age 18 years or older
  • were willing to be randomized to one of four groups: 1) CB 4 wks/Calm 4 wks, 2) Calm 4 wks/CB 4 wks, 3) educational material 4 wks/CB 4 wks, and 4) educational material 4 wks/Calm 4 wks,

Exclusion Criteria:

  • engaged in ≥10 min/day of meditation on ≥5 days/week for the past 6 months
  • engaged in ≥60 min/week of tai chi, qigong, or yoga each week
  • utilized either App #1 or Calm
  • resided outside of the United States of America

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): NCT03726944


Locations
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United States, Arizona
Arizona Biomedical Collaborative
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Investigators
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Principal Investigator: Jennifer Huberty, PhD Arizona State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Huberty, Associate Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03726944    
Other Study ID Numbers: STUDY00006404
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Neoplasms
Bone Marrow Diseases
Hematologic Diseases