- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267110
Engaging Diverse Underserved Communities to Bridge the Mammography Divide
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If you decide to participate in the program, your participation will last 4 months. You will complete the Healthy Living Kansas-Breast Health survey by computer. The survey will take about 20 minutes to complete. You will be randomly assigned (like flipping a coin) to one of two groups. The groups will receive different breast health information. After completing the survey, you agree to be contacted by telephone in 4 months to answer questions. You will be asked for your name, home address, and phone number.
You will be given information about breast cancer and mammography. You may or may not benefit from the information provided. Care will be taken to safeguard the information you provide but under rare circumstances confidentiality breaches may occur.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Latina or AI/AN woman residing in one of participating communities
- Aged ≥40 years of age
- Not up to date on mammography screening
- Home address & access to a working telephone
- Responded to 120-day post randomization follow-up call
Exclusion Criteria:
- Receipt of mammogram within past year
- Acute medical illness, history of breast cancer, 1st
- Cognitive impairment or inappropriate affect or behavior
- Another household member enrolled in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
For persons who are randomized to the MI2 intervention arm, the HLK-BH program will guide participants through a series of questions to fully delineate step-by-step breast cancer screening intentions of participants the when, where and how of screening)and encourage follow through on these intentions.
|
Active Comparator: Control
|
Each participant in the C intervention arm will receive the same brief one-on-one breast cancer screening education information delivered in person by a CHW as MI2 participants.
In additional participants will go through the Healthy Living Kansas-Breast Health computerized screening and intervention program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
120-day post randomization mammography screening completion
Time Frame: day 120
|
To compare the 120-day post randomization mammography screening completion rates of individuals who receive a computerized mammography "implementation intentions" (MI2) intervention, versus a comparison computerized condition of general breast cancer prevention health education (C).
|
day 120
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the screening mammography self-reported barriers after 120-days post randomization
Time Frame: day 120
|
To compare the screening mammography self-reported barriers after 120-days post randomization between those receiving a mammography "implementation intentions" intervention (MI2) and those receiving only a general breast cancer prevention health education intervention (C).
|
day 120
|
To compare changes in mammography screening Precaution Adoption Process Model
Time Frame: day 120
|
To compare changes in mammography screening Precaution Adoption Process Model decisional stage from baseline to 120 days post randomization between individuals in the MI2 and C study arms.
|
day 120
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberly Engelman, PhD, University of Kansas Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12371
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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