NCT02601794

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

November 4, 2015

Last Update Submit

June 20, 2016

Conditions

Breast Cancer

Keywords

Breast CancermHealthMindfulnessComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Change in breast cancer-related quality of life scores

    Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Change from baseline FACT-B scores at 12 weeks

Secondary Outcomes (2)

  • Change in mindfulness scores

    Change from baseline MAAS scores at 12 weeks

  • Change in spiritual quality of life scores

    Change from baseline FACIT-SP scores at 12 weeks

Other Outcomes (4)

  • Change in pain-related severity and interference

    Change from baseline BPI scores at 12 weeks

  • App usability

    Measured at 5 weeks

  • eHealth literacy scores

    Measured at baseline

  • +1 more other outcomes

Study Arms (2)

App-based Mindfulness Training

EXPERIMENTAL

12 week mindfulness training delivered remotely through mobile app

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

Interventions

App-based Mindfulness TrainingBEHAVIORAL

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

Also known as: AMT
App-based Mindfulness Training

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PMID: 8080219BACKGROUND

  • 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.

    PMID: 12008794BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 9060536BACKGROUND

  • 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.

    PMID: 12703651BACKGROUND

  • 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.

    PMID: 17213046BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kristen Rosen, MPH

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 10, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

US(1)