Clinical trial NCT02205736: Breast Health Education for Underserved Latino Women
Official title: A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast health education
Latino women
Group education
Breast cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2014-07-31
Enrollment: 329
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 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).
timeFrame: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 3-Month Contact; duration is approximately three months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Carolinas Healthcare System, Levine Cancer Institute
name: Daniel Carrizosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Healthcare System, Levine Cancer Institute
name: Anna Bawtinhimer, BSPH
role: STUDY_DIRECTOR
affiliation: Carolinas Healthcare System - Levine Cancer Institute
name: Jim Symanowski, PhD
role: STUDY_DIRECTOR
References: