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Clinical Trials/NCT02205736
NCT02205736
Completed
Not Applicable

A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County

Wake Forest University Health Sciences1 site in 1 country250 target enrollmentJuly 2014
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Wake Forest University Health Sciences
Enrollment
250
Locations
1
Primary Endpoint
The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention).
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
November 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Carrizosa

PI

Wake Forest University Health Sciences

Eligibility Criteria

Inclusion Criteria

  • At least 18 years old
  • Resident of Union County or Mecklenburg County, North Carolina

Exclusion Criteria

  • Non-Latino
  • Less than 18 years old
  • Not a resident of Union County or Mecklenburg County, North Carolina

Outcomes

Primary Outcomes

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention).

Time Frame: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.

Participants completed 25-item questionnaires requiring True/False responses to evaluate breast health knowledge at Baseline and Post-Intervention. True/False responses were recoded as being correct or incorrect, resulting in 25 unique 2x2 contingency tables of paired, dichotomous survey responses. Reported here are the frequencies of paired subject responses for each question on the Baseline and Post-Intervention questionnaires. Questions are listed below as Row Titles. Abbreviations to note include: Question: Q Mammography, Mammogram: MAM Breast cancer: BC True/False: T/F

Secondary Outcomes

  • The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Three Months After the Intervention to Assess Retention (i.e., 3-Month Contact)(Baseline to 3-Month Contact; duration is approximately three months)

Study Sites (1)

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