A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The investigators are conducting a web-based study to explore the use of a mindfulness app to
      improve quality of life among women with breast cancer.

      Eligible participants will be asked to provide informed consent to participate and submit a
      data authorization form to obtain information from the app at the end of the project.

      This 12-week project will randomly assign participants to one of two groups:

      Group 1 (AMT) will receive the mindfulness app right away; Group 2 (WC) will receive the
      mindfulness app at the end of 12 weeks.

      All participants will receive a welcome email with group designation. Participants assigned
      to Group 1 (AMT) will also receive app download instructions and pass code. Group 1 will be
      asked to complete the app's first 10-minute mindfulness exercise, at minimum.

      Participants assigned to Group 2 (WC) will be notified that they will receive app download
      instructions and pass code at the end of 12 weeks.

      Regardless of group assignment, all participants will be asked to complete web-based survey
      assessments 4 different times throughout the study (baseline, week 5, week 9, 12-week follow
      up). The surveys will be related to quality of life, mindfulness, mobile technology, health
      literacy, and chronic pain.

      To encourage participation, a member of the study team will send out weekly check-in emails.

      Once all data has been collected, app developers will provide the investigators with app data
      for each participant, including times accessed, length of time using app. This information
      will help the investigators observe which app characteristics are most useful, as well as the
      optimal amount of time needed to obtain benefit from the app.

      The investigators goals are to understand how using the mindfulness app compares to not using
      the mindfulness app. The investigators will also observe whether the app contributes to
      participants' quality of life. The investigators also want to understand more about how women
      use health apps overall. This information may inform issues related to delivery of app-based
      health interventions among women with breast cancer.
    

Detailed description: 
      The proposed project utilizes a randomized controlled trial design to explore the efficacy of
      a commercial app-based mindfulness training (AMT) intervention for women with breast cancer,
      compared to waitlist control (WC).

      Recruitment commenced in August 2015 and will continue until March 2016. Up to 180
      participants will be recruited using a combination recruitment strategy, including social
      media, word of mouth, registries, and informing colleagues of the project. The proposed
      sample size, powered to detect changes in quality of life, is adequate for 70% power, while
      accounting for attrition.

      Eligible participants will be randomly assigned to app-based mindfulness training (AMT; n=90)
      or waitlist control (WC; n=90). Group assignment will be stratified by endorsement of past
      year mind-body complementary or alternative medicine practice indicated at baseline.

      Informed consent will be obtained at baseline, prior to completion of assessments.
      Participants will also be asked to sign a data authorization allowing the research team to
      obtain app metadata at the completion of the study:

      At baseline (pre-group assignment), participants will be required to complete web-based
      survey assessments related to quality of life, mindfulness, health literacy, health apps, and
      chronic pain. A unique web link to a secure data collection website will be emailed to each
      participant. Participants will have up to 7 days to complete assessments. Group assignment
      will be ongoing, as participants enroll.

      All participants completing baseline assessments will receive a welcome email indicating
      group assignment. Participants assigned to AMT will receive app download instructions and
      pass code in the welcome email.

      All participants will receive weekly check-in emails to facilitate engagement and retention.

      At week 5 and week 9, all participants will complete web-based survey assessments related to
      quality of life, mindfulness, and chronic pain. A fidelity check will be completed to
      identify group contamination or new use of other health apps.

      At 12-week follow up, all participants will complete web-based survey assessments related to
      quality of life, mindfulness, and chronic pain. A fidelity check will be completed to
      identify group contamination or new use of other health apps. At this time, participants
      assigned to WC will receive app download instructions and pass code.

      At the study completion, app developers will provide the investigators with app log data at
      the individual level. This information will help the investigators observe which app
      characteristics are most useful, as well as the optimal amount of time needed to obtain
      benefit from the app.
    

Intervention name(s): App-based Mindfulness Training
Intervention type(s): Behavioral
Intervention description(s): A commercially available mindfulness training app delivered to smartphone or tablet.
Other intervention name(s): AMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer; mHealth; Mindfulness; Complementary Therapies