Skip to main content
OpenTrials
Completed

NCT Number: NCT02205736

Breast Health Education for Underserved Latino Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Health Education

Other

Small group breast health educational sessions for Latino women in home setting.

Primary outcomes

  1. 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

  1. 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)

    Time frame: Baseline to 3-Month Contact; duration is approximately three months

    Participants completed 25-item questionnaires requiring True/False responses to evaluate breast health knowledge at Baseline and 3-Month Contact. 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 3-Month Contact questionnaires.

    Questions are listed below as Row Titles.

    Abbreviations to note include:

    Question: Q Mammography, Mammogram: MAM Breast cancer: BC True/False: T/F

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 31, 2014
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.