Breast Health Education for Underserved Latino Women

NCT ID: NCT02205736

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Living Room Visit participants

Latino women who received breast health education while attending a Living Room Visit.

Group Type: OTHER

Breast Health Education

Intervention Type: OTHER

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

Interventions

Breast Health Education

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atrium Health Levine Cancer Institute

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Carrizosa, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Healthcare System, Levine Cancer Institute

Anna Bawtinhimer, BSPH

Role: STUDY_DIRECTOR

Carolinas Healthcare System, Levine Cancer Institute

Jim Symanowski, PhD

Role: STUDY_DIRECTOR

Carolinas Healthcare System - Levine Cancer Institute

Locations

Levine Cancer Institute

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

LCI-BRE-NOS-HEP-001

Identifier Type: -

Identifier Source: org_study_id