CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
App-based Mindfulness Trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02601794
NCT02601794N/ACompleted

Delivering an Intervention to Accompany Supportive Care

The University of Texas Health Science Center at San Antonio·interventional·Posted Nov 10, 2015·Updated Jun 22, 2016

In Brief

A clinical study evaluating App-based Mindfulness Training for Breast Cancer. Completed, enrolled 112 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartAug 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.6 years ago

Interventions

App-based Mindfulness Trainingbehavioral

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