A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
| End Date: | May 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Kristen Rosen, MPH
Phone: 210-562-5418
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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