Clinical trial NCT03726944: The Feasibility of Delivering Consumer-based Meditation Applications to Myeloproliferative Neoplasm Patients
Official title: Feasibility of Using a Consumer-based Mobile App to Improve Fatigue and Emotional Symptoms in Myeloproliferative Neoplasm Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myeloproliferative Neoplasm
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This was a four-group, randomized controlled trial with a cross-over design. Patients were enrolled into one of four groups with varying order of receiving two consumer-based meditation smartphone (i.e., unnamed consumer-based app \[CB app\], Calm app) apps in 4-week increments over eight weeks. Group #1 received the CB App followed by the Calm app; Group #2 received the Calm app followed by the CB app; Group #3 received educational control followed by the CB app and Group #4 received educational control followed by the Calm app.

MPN patients were recruited online through MPN organizational partners with a single page, broad overview of the study and its requirements. The study was advertised as a smartphone app meditation study. MPN patients interested in the study were asked to complete an online eligibility questionnaire administered via Qualtrics. Researchers then checked completed eligibility questionnaires as they were completed and emailed patients with their eligibility status.

If ineligible, patients received an email stating their ineligibility status as well as links to both consumer-based apps used in the study in case the ineligible participant was interested in trying meditation. Eligible patients were invited to participate in a 20-minute phone appointment in which the study details and informed consent were described in detail. MPN patients who completed the intake appointment were then sent an informed consent electronically via Qualtrics that included a place for their electronic signature.

Upon receipt of the completed informed consent, participants were randomly assigned to one of four groups. A group assignment list was generated prior to study commencement with randomizer.org. This pre-generated list was then used by research personnel to place eligible, consented MPN patients into their group assignment (i.e., Group #1, Group #2, Group #3, Group #4; described below) in the order in which they consented to participate. Randomized participants were provided with a "welcome email" that contained a) a welcome letter introducing them to the study, b) a calendar detailing important study dates, c) instructions specific to the first assigned condition (i.e., CB app, Calm app, or educational control) to be introduced for the first four weeks. After participants completed the first of their two, four-week conditions (i.e., CB App, Calm, or control), they were provided with another email that included instructions specific to their final condition (i.e., CB app, Calm app, or educational control).

Unnamed Consumer-Based (CB) App The CB app was an already existing consumer-based smartphone app. The first and second week consisted of meditation that was basic introductory, and educational for those new to meditation. Weeks three and four consisted of a new and unique daily meditation that study participants could select from a library of meditations within the app. Each of the daily meditations had a different focus (e.g., grief, gratitude, choice, letting go, etc.) and were \~10-12 minutes in length.

Description of Conditions

Calm App The Calm app was an already-existing, consumer-based meditation app. The first week of the intervention included the "7 Days of Calm", which consists of seven days of introductory meditations that incorporated basic, educational information for those new to meditation while introducing brief experiential practices within that short period of time. Weeks two through four consisted of the "Daily Calm", which is a new and unique daily guided meditation that was provided by the app. Each of the daily meditations had a different focus (e.g., practicing patience, loving-kindness, gratitude, etc.) and were \~10-12 minutes in length.

Educational Control The control condition was provided with educational material handout that was developed by the research team prior to the study. The handout addressed MPN patient fatigue (e.g., What causes fatigue?) as well as examples of and information related to evidence-based fatigue-management strategies.

Description of Groups

Group #1 (CB App + Calm) Group #1 was assigned the CB App (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the CB App via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could.

Group #2 (Calm APP + CB App) Group #2 was assigned the Calm app (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could.

Group #3 (Control + CB App) Group #3 was assigned educational control (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could.

Group #4 (Control + Calm) Group #4 was assigned educational control (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., \~70 min/week) but encouraged to do more if they could.

All study participants completed patient-reported outcomes measures via an online questionnaire at baseline (week 0), mid-point (week 5), and post-intervention (week 9).

Eligibility 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

Primary outcomes:
measure: Acceptability of Intervention: survey
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Demand of Meditation
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Limited-Efficacy Testing of Meditation
timeFrame: Change from Baseline to Week 5 and Week 9
Secondary outcomes:
measure: MPN Total Symptom Burden (severity and symptomology)
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Fatigue
timeFrame: Change from Baseline to Week 5 and Change from Baseline to Week 9
measure: Anxiety
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Depression
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Sleep Disturbance
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Sexual Function
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Pain Intensity
timeFrame: Change from Baseline to Week 5 and Week 9
measure: Global Health
timeFrame: Change from Baseline to Week 5 and Week 9
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.