Breast Health Education for Underserved Latino Women

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205736
• Other study ID #: LCI-BRE-NOS-HEP-001
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: October 6, 2017
• Start date: July 2014
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Carolinas Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Breast Health Education
Small group breast health educational sessions for Latino women in home setting.

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Carolinas Healthcare System	Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline of breast cancer health literacy	Analysis of pre-education and post-education questionnaires administered to subjects.	1 year