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Breast Health Education for Underserved Latino Women

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ClinicalTrials.gov Identifier: NCT02205736
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
Levine Cancer Institute
Information provided by (Responsible Party):
Daniel Carrizosa, Carolinas Healthcare System

July 29, 2014
July 31, 2014
October 9, 2017
July 2014
November 2016   (Final data collection date for primary outcome measure)
Change in baseline of breast cancer health literacy [ Time Frame: 1 year ]
Analysis of pre-education and post-education questionnaires administered to subjects.
Same as current
Complete list of historical versions of study NCT02205736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Breast Health Education for Underserved Latino Women
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Breast Cancer
Other: Breast Health Education
Small group breast health educational sessions for Latino women in home setting.
Living Room Visit participants
Latino women who received breast health education while attending a Living Room Visit.
Intervention: Other: Breast Health Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Same as current
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02205736
LCI-BRE-NOS-HEP-001
Yes
Not Provided
Plan to Share IPD: No
Daniel Carrizosa, Carolinas Healthcare System
Carolinas Healthcare System
Levine Cancer Institute
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
Carolinas Healthcare System
October 2017

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