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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:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Breast Cancer Other: Breast Health Education

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
Study Start Date : July 2014
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Living Room Visit participants
Latino women who received breast health education while attending a Living Room Visit.
Other: Breast Health Education
Small group breast health educational sessions for Latino women in home setting.


Outcome Measures

Primary Outcome Measures :
  1. Change in baseline of breast cancer health literacy [ Time Frame: 1 year ]
    Analysis of pre-education and post-education questionnaires administered to subjects.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205736


Locations
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Levine Cancer Institute
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
More Information

Responsible Party: Daniel Carrizosa, PI, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02205736     History of Changes
Other Study ID Numbers: LCI-BRE-NOS-HEP-001
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Carrizosa, Carolinas Healthcare System:
Breast health education
Latino women
Group education
Breast cancer