Breast Health Education for Underserved Latino Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Carolinas Healthcare System
Sponsor:
Collaborator:
Levine Cancer Institute
Information provided by (Responsible Party):
Daniel Carrizosa, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT02205736
First received: July 29, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Breast Health Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Change in baseline of breast cancer health literacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Analysis of pre-education and post-education questionnaires administered to subjects.


Estimated Enrollment: 250
Study Start Date: July 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Living Room Visit participants
Latino women who received breast health education while attending a Living Room Visit.
Other: Breast Health Education
Small group breast health educational sessions for Latino women in home setting.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02205736

Contacts
Contact: Anna Bawtinhimer (980) 442-3056 Anna.Bawtinhimer@carolinashealthcare.org
Contact: Magbis Love (980) 442-6362 Magbis.Love@carolinashealthcare.org

Locations
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Anna Bawtinhimer    980-442-3056    Anna.Bawtinhimer@carolinashealthcare.org   
Contact: Magbis Love       Magbis.Love@carolinashealthcare.org   
Principal Investigator: Daniel Carrizosa, MD         
Sub-Investigator: Magbis Love         
Sub-Investigator: Nury Steuerwald, PhD, HCLD         
Sub-Investigator: Dina Carey         
Sub-Investigator: Anna Bawtinhimer, BSPH         
Sub-Investigator: Kris Blackley, RN         
Sponsors and Collaborators
Carolinas Healthcare System
Levine Cancer Institute
Investigators
Principal Investigator: Daniel Carrizosa, MD Carolinas Healthcare System, Levine Cancer Institute
Study Director: Anna Bawtinhimer, BSPH Carolinas Healthcare System, Levine Cancer Institute
  More Information

No publications provided

Responsible Party: Daniel Carrizosa, PI, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02205736     History of Changes
Other Study ID Numbers: LCI-BRE-NOS-HEP-001
Study First Received: July 29, 2014
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Breast health education
Latino women
Group education
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014