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Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening

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ClinicalTrials.gov Identifier: NCT01972048
Recruitment Status : Withdrawn (PI Left University)
First Posted : October 30, 2013
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date  ICMJE October 24, 2013
First Posted Date  ICMJE October 30, 2013
Last Update Posted Date January 26, 2018
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
Mammogram receipt [ Time Frame: 1 week ]
The receipt of mammogram (or scheduled appointment) will be measured by self-report.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01972048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
  • Breast cancer knowledge [ Time Frame: 1 week ]
    Breast cancer knowledge will be measured by means of McCance, Mooney and Smith's ten-item "Breast Cancer Knowledge" test.
  • Breast cancer health beliefs [ Time Frame: 1 week ]
    Change in health beliefs will be measured using Champion's Health Belief Model scales.
  • Culture specific attitudes toward breast cancer [ Time Frame: 1 week ]
    Culture-specific attitudes toward breast cancer screening, such as modesty, will be measured utilizing six items from Tang and colleagues and fatalistic attitudes toward breast cancer will be measured by means of three items from Taylor and colleagues.
  • Participant intent to undergo screening [ Time Frame: 1 week ]
    We will measure participant intent to undergo screening by use of an adapted version of the transtheoretical model.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
Official Title  ICMJE Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Brief Summary Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.
Detailed Description Specific aims over the three-year period include the following: (1) The first year will be devoted to intervention and protocol development. A major emphasis in year 1 will be developing the community advisory board (CAB), conducting a series of pre-intervention focus groups, and working with pertinent persuasive technology consultants to develop and pilot-test the intervention. (2) The second year and the first half of the third year will focus on delivery of the intervention. (3) the second half of the third year will be devoted to data analysis and dissemination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Behavioral: mMammogram
    Text messages delivered via mobile app to participants designed to inform them about breast cancer screening and encourage them to schedule a mammogram.
  • Other: Print brochure
    Mailed print brochure about breast cancer screening and community resources.
Study Arms  ICMJE
  • Active Comparator: Control group
    Participants in the control group will receive the mailed print brochure about breast cancer screening and community resources.
    Intervention: Other: Print brochure
  • Experimental: Intervention group
    Participants will receive the mMammogram intervention.
    Intervention: Behavioral: mMammogram
Publications * Lee H, Ghebre R, Le C, Jang YJ, Sharratt M, Yee D. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Nov 7;5(11):e154. doi: 10.2196/mhealth.7091.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2013)
150
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Korean American immigrant women
  • Aged 40-79
  • Residence in Minnesota
  • Possession of mobile phone with text-message function
  • Possession of active email account

Exclusion Criteria:

  • Mammogram receipt within the past 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972048
Other Study ID Numbers  ICMJE 2013NTLS063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hee Y Lee, PhD University of Minnesota - Clinical and Translational Science Institute
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP