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

NCT02601794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-06-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

App-based Mindfulness Training

A commercially available mindfulness training app delivered to smartphone or tablet.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Kristen Rosen, MPH · University of Texas Health Science Center San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601794 on ClinicalTrials.gov