Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mMammogram
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Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, breast cancer screening, mammogram
Eligibility Criteria
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
Sites / Locations
- University of Minnesota Masonic Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
Participants in the control group will receive the mailed print brochure about breast cancer screening and community resources.
Participants will receive the mMammogram intervention.
Outcomes
Primary Outcome Measures
Mammogram receipt
The receipt of mammogram (or scheduled appointment) will be measured by self-report.
Secondary Outcome Measures
Breast cancer knowledge
Breast cancer knowledge will be measured by means of McCance, Mooney and Smith's ten-item "Breast Cancer Knowledge" test.
Breast cancer health beliefs
Change in health beliefs will be measured using Champion's Health Belief Model scales.
Culture specific attitudes toward breast cancer
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
We will measure participant intent to undergo screening by use of an adapted version of the transtheoretical model.
Full Information
NCT ID
NCT01972048
First Posted
October 24, 2013
Last Updated
January 24, 2018
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01972048
Brief Title
Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
Official Title
Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI Left University
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, breast cancer screening, mammogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive the mailed print brochure about breast cancer screening and community resources.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will receive the mMammogram intervention.
Intervention Type
Behavioral
Intervention Name(s)
mMammogram
Intervention Description
Text messages delivered via mobile app to participants designed to inform them about breast cancer screening and encourage them to schedule a mammogram.
Intervention Type
Other
Intervention Name(s)
Print brochure
Intervention Description
Mailed print brochure about breast cancer screening and community resources.
Primary Outcome Measure Information:
Title
Mammogram receipt
Description
The receipt of mammogram (or scheduled appointment) will be measured by self-report.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Breast cancer knowledge
Description
Breast cancer knowledge will be measured by means of McCance, Mooney and Smith's ten-item "Breast Cancer Knowledge" test.
Time Frame
1 week
Title
Breast cancer health beliefs
Description
Change in health beliefs will be measured using Champion's Health Belief Model scales.
Time Frame
1 week
Title
Culture specific attitudes toward breast cancer
Description
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.
Time Frame
1 week
Title
Participant intent to undergo screening
Description
We will measure participant intent to undergo screening by use of an adapted version of the transtheoretical model.
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Y Lee, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29113961
Citation
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.
Results Reference
derived
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Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening
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