Breast Health Education for Underserved Latino Women
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Health Education
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast health education, Latino women, Group education, Breast cancer
Eligibility Criteria
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
Sites / Locations
- Levine Cancer Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Living Room Visit participants
Arm Description
Latino women who received breast health education while attending a Living Room Visit.
Outcomes
Primary Outcome Measures
Change in baseline of breast cancer health literacy
Analysis of pre-education and post-education questionnaires administered to subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT02205736
First Posted
July 29, 2014
Last Updated
October 6, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
Atrium Health Levine Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02205736
Brief Title
Breast Health Education for Underserved Latino Women
Official Title
A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Atrium Health Levine Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast health education, Latino women, Group education, Breast cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Living Room Visit participants
Arm Type
Other
Arm Description
Latino women who received breast health education while attending a Living Room Visit.
Intervention Type
Other
Intervention Name(s)
Breast Health Education
Intervention Description
Small group breast health educational sessions for Latino women in home setting.
Primary Outcome Measure Information:
Title
Change in baseline of breast cancer health literacy
Description
Analysis of pre-education and post-education questionnaires administered to subjects.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Carrizosa, MD
Organizational Affiliation
Carolinas Healthcare System, Levine Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Bawtinhimer, BSPH
Organizational Affiliation
Carolinas Healthcare System, Levine Cancer Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jim Symanowski, PhD
Organizational Affiliation
Carolinas Healthcare System - Levine Cancer Institute
Official's Role
Study Director
Facility Information:
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Breast Health Education for Underserved Latino Women
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