This trial has been completed.

Condition breast cancer
Treatment breast health education
Sponsor Carolinas Healthcare System
Collaborator Levine Cancer Institute
Start date July 2014
End date November 2016
Trial size 250 participants
Trial identifier NCT02205736, LCI-BRE-NOS-HEP-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Latino women who received breast health education while attending a Living Room Visit.
breast health education
Small group breast health educational sessions for Latino women in home setting.

Primary Outcomes

Change in baseline of breast cancer health literacy
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
Principal investigator Daniel Carrizosa, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Carolinas Healthcare System.