A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer (DIVAS)

June 20, 2016 updated by: Suyen Warzinski, The University of Texas Health Science Center at San Antonio

Delivering an Intervention to Accompany Supportive Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female
  2. Age ≥ 25
  3. Breast cancer diagnosis within past 5 years
  4. Willing to provide locator information for follow-up contact
  5. Reliable internet access
  6. Ownership of smartphone or tablet with following specifications: wireless capability, running on iOS or Android operating system, current software (4.4 Android; 8.0 iOS or later), and adequate memory to run the mindfulness app (43M Android; 30.2M iOS).

Exclusion Criteria:

  1. Unfamiliar with mobile phones/tablets, including ability to download and register mindfulness app
  2. Become unable to participate in a fully app and web-based intervention trial
  3. Unwilling to complete online questionnaires
  4. Unwilling to use personal phone/tablet to test intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App-based Mindfulness Training
12 week mindfulness training delivered remotely through mobile app
Behavioral: App-based Mindfulness Training
A commercially available mindfulness training app delivered to smartphone or tablet.
Other Names:
  • AMT
No Intervention: Waitlist Control
No intervention provided during study period. 12 week mindfulness training will be delivered through mobile app once all study assessments have been completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in breast cancer-related quality of life scores
Time Frame: Change from baseline FACT-B scores at 12 weeks
Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Change from baseline FACT-B scores at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mindfulness scores
Time Frame: Change from baseline MAAS scores at 12 weeks
Measured by the Mindful Attention Awareness Scale (MAAS)
Change from baseline MAAS scores at 12 weeks
Change in spiritual quality of life scores
Time Frame: Change from baseline FACIT-SP scores at 12 weeks
Measured by the Functional Assessment of Chronic Illness Therapy (FACIT-SP)
Change from baseline FACIT-SP scores at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain-related severity and interference
Time Frame: Change from baseline BPI scores at 12 weeks
Measured by the Brief Pain Inventory (BPI)
Change from baseline BPI scores at 12 weeks
App usability
Time Frame: Measured at 5 weeks
Measured by the Systems Usability Scale
Measured at 5 weeks
eHealth literacy scores
Time Frame: Measured at baseline
Measured by the eHealth Literacy Scale (eHEALS)
Measured at baseline
Health literacy scores
Time Frame: Measured at baseline
Measured by the Brief Health Literacy Screen
Measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Kristen Rosen, MPH, University of Texas Health Science Center San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20140010H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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