Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02601794
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2015-11-04
Brief Title:
A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Delivering an Intervention to Accompany Supportive Care
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVAS
Brief 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 apps 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
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 apps 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 n90 or waitlist control WC n90 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
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 n90 or waitlist control WC n90 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None