Breast Health Education for Underserved Latino Women
October 6, 2017 updated by: Daniel Carrizosa, Wake Forest University Health Sciences
A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
Subjects will be recruited from the participants in the Union and Mecklenburg County Living Room Visits.
Participants in the Living Room Visit will have been recruited using community event flyers.
During the Living Room Visits, the Health Educator will provide a general overview of the study.
Individuals who are interested in participating in the study will then be generally screened for eligibility by the Protocol Coordinator who will then proceed to provide informed consent to potential subjects.
Study Overview
Detailed Description
In an effort to increase early detection of breast cancer our program is designed to remove some of the most common barriers faced by uninsured Latino women including lack of breast health knowledge and inability to pay for screening.
The Levine Cancer Institute offers breast cancer education and screening in the growing Latino populations of both Mecklenburg and Union Counties through educational programs known as "Living Room Visits."
Living Room Visits are educational sessions hosted at a participant's house that will be led by a Carolinas Healthcare System (CHS) certified bilingual health educator.
At least 250 women will participant in the educational sessions between both counties with each session hosting 12-15 participants.
Of those women participating in Living Room Visits, those interested will be individually informed of the research opportunity and provided informed consent before being asked to take a pre-test survey.
After the educational session, subjects who consented to the study will also complete a post-test survey.
Three months after each Living Room Visit, subjects will also be called to complete another post-test survey to assess educational retention.
Phone calls and post-test surveys will be administered by Collaborative Institutional Training Initiative (CITI) trained CHS certified bilingual employees only.
Analysis of the pre and post-intervention surveys will be administered by a CHS statistician using de-identified data.
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Latino
- Female
- At least 18 years old
- Resident of Union County or Mecklenburg County, North Carolina
Exclusion Criteria:
- Non-Latino
- Male
- Less than 18 years old
- Not a resident of Union County or Mecklenburg County, North Carolina
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Living Room Visit participants
Latino women who received breast health education while attending a Living Room Visit.
|
Small group breast health educational sessions for Latino women in home setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline of breast cancer health literacy
Time Frame: 1 year
|
Analysis of pre-education and post-education questionnaires administered to subjects.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel Carrizosa, MD, Carolinas Healthcare System, Levine Cancer Institute
- Study Director: Anna Bawtinhimer, BSPH, Carolinas Healthcare System, Levine Cancer Institute
- Study Director: Jim Symanowski, PhD, Carolinas Healthcare System - Levine Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
July 29, 2014
First Submitted That Met QC Criteria
July 30, 2014
First Posted (Estimate)
July 31, 2014
Study Record Updates
Last Update Posted (Actual)
October 9, 2017
Last Update Submitted That Met QC Criteria
October 6, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCI-BRE-NOS-HEP-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.