Breast CancerDIVASNCT02601794
A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
A study testing App-based Mindfulness Training in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- App-based Mindfulness Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 25
- Breast cancer diagnosis within past 5 years
- Willing to provide locator information for follow-up contact
- Reliable internet access
- 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).
Who cannot join
- Unfamiliar with mobile phones/tablets, including ability to download and register mindfulness app
- Become unable to participate in a fully app and web-based intervention trial
- Unwilling to complete online questionnaires
- Unwilling to use personal phone/tablet to test intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read more
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.
Read the 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; 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
- Breast Cancer
- Being tested
- App-based Mindfulness Training
- Keywords
- Breast Cancer, mHealth, Mindfulness, Complementary Therapies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Mindfulness TrainingBehavioural
Also called AMT
A commercially available mindfulness training app delivered to smartphone or tablet.
| Study group | Role | What they receive |
|---|---|---|
| App-based Mindfulness Training | Experimental | 12 week mindfulness training delivered remotely through mobile app Receives: Behavioral: App-based Mindfulness Training |
| Waitlist Control | No intervention | No intervention provided during study period. 12 week mindfulness training will be delivered through mobile app once all study assessments have been completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast cancer-related quality of life scores
Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Measured: Change from baseline FACT-B scores at 12 weeks
Secondary outcomes (2)
Change in mindfulness scores
Measured by the Mindful Attention Awareness Scale (MAAS)
Measured: Change from baseline MAAS scores at 12 weeks
Change in spiritual quality of life scores
Measured by the Functional Assessment of Chronic Illness Therapy (FACIT-SP)
Measured: Change from baseline FACIT-SP scores at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suyen Warzinski, The University of Texas Health Science Center at San Antonio
- Investigators
- Kristen Rosen, MPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601794
- Sponsor's protocol ID
- HSC20140010H
- Acronym
- DIVAS
- Status last verified
- Jun 2016
- First submitted
- 4 Nov 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Peterman 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.
PubMed 12008794Brooke 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.
PubMed 9060536Brown 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.
PubMed 12703651Norman 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.
PubMed 17213046Haun 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering an Intervention to Accompany Supportive Care
- ClinicalTrials.gov ID
- NCT02601794
- Acronym / sponsor ID
- DIVAS / HSC20140010H
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, mHealth, Mindfulness, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based Mindfulness Training | Experimental | Behavioral: App-based Mindfulness Training12 week mindfulness training delivered remotely through mobile app |
| Waitlist Control | No intervention | –No intervention provided during study period. 12 week mindfulness training will be delivered through mobile app once all study assessments have been completed |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Age ≥ 25
- Breast cancer diagnosis within past 5 years
- Willing to provide locator information for follow-up contact
- Reliable internet access
Key exclusion criteria (4 listed)
- Unfamiliar with mobile phones/tablets, including ability to download and register mindfulness app
- Become unable to participate in a fully app and web-based intervention trial
- Unwilling to complete online questionnaires
- Unwilling to use personal phone/tablet to test intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Mindfulness TrainingAlso: AMTA commercially available mindfulness training app delivered to smartphone or tablet. | Behavioural | App-based Mindfulness Training |
Primary outcome
Change in breast cancer-related quality of life scores
Time frame: Change from baseline FACT-B scores at 12 weeks
Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
2 secondary outcomes
Change in mindfulness scores
Time frame: Change from baseline MAAS scores at 12 weeks
Change in spiritual quality of life scores
Time frame: Change from baseline FACIT-SP scores at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 12008794Peterman 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.
- BackgroundBrooke 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.
- Background: PubMed 9060536Brady 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.
- Background: PubMed 12703651Brown 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.
- Background: PubMed 17213046Norman 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.
- BackgroundHaun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Rosen, MPH principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based Mindfulness Training in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breast cancer-related quality of life scores (time frame: Change from baseline FACT-B scores at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601794, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.