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

NCT03726944 | Completed

• 1 other identifier: STUDY00006404
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention: survey

  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.

  Change from Baseline to Week 5 and Week 9

• Demand of Meditation

  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).

  Change from Baseline to Week 5 and Week 9

• Limited-Efficacy Testing of Meditation

  Limited-efficacy testing was measured with Cohen's d effect sizes calculated for patient-reported outcomes (described below as secondary outcomes).

  Change from Baseline to Week 5 and Week 9

Secondary Outcomes (8)

• MPN Total Symptom Burden (severity and symptomology)

  Change from Baseline to Week 5 and Week 9

• Fatigue

  Change from Baseline to Week 5 and Change from Baseline to Week 9

• Anxiety

  Change from Baseline to Week 5 and Week 9

• Depression

  Change from Baseline to Week 5 and Week 9

• Sleep Disturbance

  Change from Baseline to Week 5 and Week 9

Study Arms (4)

Group 1 - Meditation1+Meditation2

OTHER

8 weeks in total; 4 weeks of unnamed consumer-based meditation app + 4 weeks of Calm meditation app

Behavioral: Calm App Meditation; Behavioral: Unnamed Consumer-Based App Meditation

Group 2 - Meditation2+Meditation1

OTHER

8 weeks in total; 4 weeks of Calm meditation app + 4 weeks of unnamed consumer-based meditation app

Behavioral: Calm App Meditation; Behavioral: Unnamed Consumer-Based App Meditation

Group 3 - Control+Meditation1

OTHER

8 weeks in total; 4 weeks of educational control + 4 weeks of unnamed consumer-based meditation app

Behavioral: Unnamed Consumer-Based App Meditation; Other: Educational Control

Group 4 - Control+Meditation2

OTHER

8 weeks in total; 4 weeks of educational control + 4 weeks of Calm meditation app

Behavioral: Calm App Meditation; Other: Educational Control

Interventions

Calm App Meditation BEHAVIORAL

The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.

Group 1 - Meditation1+Meditation2; Group 2 - Meditation2+Meditation1; Group 4 - Control+Meditation2

Unnamed Consumer-Based App Meditation BEHAVIORAL

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 1 - Meditation1+Meditation2; Group 2 - Meditation2+Meditation1; Group 3 - Control+Meditation1

Educational Control OTHER

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

Group 3 - Control+Meditation1; Group 4 - Control+Meditation2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• Huberty J, Eckert R, Larkey L, Kurka J, Rodriguez De Jesus SA, Yoo W, Mesa R. Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials. JMIR Form Res. 2019 Apr 29;3(2):e12662. doi: 10.2196/12662.

  PMID: 31033443 DERIVED

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jennifer Huberty, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 1, 2018
• Study Start: July 31, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)