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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02601794

Run by

The University of Texas Health Science Center at San Antonio

People needed

112

Starts

2015-08-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-22

Who can join

Age: 25 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Age ≥ 25
• Breast cancer diagnosis within past 5 years
• Willing to provide locator information for follow-up contact
• Reliable internet access
• 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).

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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