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临床试验/NCT03726944
NCT03726944已完成不适用

Feasibility of Using a Consumer-based Mobile App to Improve Fatigue and Emotional Symptoms in Myeloproliferative Neoplasm Patients

Arizona State University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Limited-Efficacy Testing of Meditation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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,

排除标准

  • 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

研究组 & 干预措施

Group 1 - Meditation1+Meditation2

Other

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

干预措施: Unnamed Consumer-Based App Meditation (Behavioral)

Group 2 - Meditation2+Meditation1

Other

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

干预措施: Calm App Meditation (Behavioral)

Group 1 - Meditation1+Meditation2

Other

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

干预措施: Calm App Meditation (Behavioral)

Group 2 - Meditation2+Meditation1

Other

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

干预措施: Unnamed Consumer-Based App Meditation (Behavioral)

Group 3 - Control+Meditation1

Other

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

干预措施: Educational Control (Other)

Group 3 - Control+Meditation1

Other

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

干预措施: Unnamed Consumer-Based App Meditation (Behavioral)

Group 4 - Control+Meditation2

Other

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

干预措施: Calm App Meditation (Behavioral)

Group 4 - Control+Meditation2

Other

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

干预措施: Educational Control (Other)

结局指标

主要结局

Limited-Efficacy Testing of Meditation

时间窗: 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).

Acceptability of Intervention: survey

时间窗: 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.

Demand of Meditation

时间窗: 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).

次要结局

  • Fatigue(Change from Baseline to Week 5 and Change from Baseline to Week 9)
  • Pain Intensity(Change from Baseline to Week 5 and Week 9)
  • MPN Total Symptom Burden (severity and symptomology)(Change from Baseline to Week 5 and Week 9)
  • Anxiety(Change from Baseline to Week 5 and Week 9)
  • Sexual Function(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)
  • Global Health(Change from Baseline to Week 5 and Week 9)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Huberty

Associate Professor

Arizona State University

研究点 (2)

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