A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
NCT ID: NCT02601794
Last Updated: 2016-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2015-08-31
2016-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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App-based Mindfulness Training
12 week mindfulness training delivered remotely through mobile app
App-based Mindfulness Training
A commercially available mindfulness training app delivered to smartphone or tablet.
Waitlist Control
No intervention provided during study period. 12 week mindfulness training will be delivered through mobile app once all study assessments have been completed
No interventions assigned to this group
Interventions
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App-based Mindfulness Training
A commercially available mindfulness training app delivered to smartphone or tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
25 Years
70 Years
FEMALE
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Suyen Warzinski
Research Scientist
Principal Investigators
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Kristen Rosen, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio
Locations
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University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Countries
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References
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Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.
Brooke J. SUS: a "quick and dirty" usability scale. In Jordan PW, Thomas B, McClelland IL, Weerdmeester B, eds. Usability Evaluation In Industry. Boca Raton: CRC Press; 1996:189-94.
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
Haun J, Noland-Dodd V, Varnes J, Graham-Pole J, Rienzo B, Donaldson P. Testing the BRIEF health literacy screening tool. Federal Practitioner 26(12): 24-31, 2009.
Other Identifiers
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HSC20140010H
Identifier Type: -
Identifier Source: org_study_id
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