<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02205736</url>
  </required_header>
  <id_info>
    <org_study_id>LCI-BRE-NOS-HEP-001</org_study_id>
    <nct_id>NCT02205736</nct_id>
  </id_info>
  <brief_title>Breast Health Education for Underserved Latino Women</brief_title>
  <official_title>A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atrium Health Levine Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will be recruited from the participants in the Union and Mecklenburg County Living&#xD;
      Room Visits. Participants in the Living Room Visit will have been recruited using community&#xD;
      event flyers. During the Living Room Visits, the Health Educator will provide a general&#xD;
      overview of the study. Individuals who are interested in participating in the study will then&#xD;
      be generally screened for eligibility by the Protocol Coordinator who will then proceed to&#xD;
      provide informed consent to potential subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In an effort to increase early detection of breast cancer our program is designed to remove&#xD;
      some of the most common barriers faced by uninsured Latino women including lack of breast&#xD;
      health knowledge and inability to pay for screening. The Levine Cancer Institute offers&#xD;
      breast cancer education and screening in the growing Latino populations of both Mecklenburg&#xD;
      and Union Counties through educational programs known as &quot;Living Room Visits.&quot; Living Room&#xD;
      Visits are educational sessions hosted at a participant's house that will be led by a&#xD;
      Carolinas Healthcare System (CHS) certified bilingual health educator. At least 250 women&#xD;
      will participant in the educational sessions between both counties with each session hosting&#xD;
      12-15 participants. Of those women participating in Living Room Visits, those interested will&#xD;
      be individually informed of the research opportunity and provided informed consent before&#xD;
      being asked to take a pre-test survey. After the educational session, subjects who consented&#xD;
      to the study will also complete a post-test survey. Three months after each Living Room&#xD;
      Visit, subjects will also be called to complete another post-test survey to assess&#xD;
      educational retention. Phone calls and post-test surveys will be administered by&#xD;
      Collaborative Institutional Training Initiative (CITI) trained CHS certified bilingual&#xD;
      employees only. Analysis of the pre and post-intervention surveys will be administered by a&#xD;
      CHS statistician using de-identified data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline of breast cancer health literacy</measure>
    <time_frame>1 year</time_frame>
    <description>Analysis of pre-education and post-education questionnaires administered to subjects.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Living Room Visit participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Latino women who received breast health education while attending a Living Room Visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breast Health Education</intervention_name>
    <description>Small group breast health educational sessions for Latino women in home setting.</description>
    <arm_group_label>Living Room Visit participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Latino&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Resident of Union County or Mecklenburg County, North Carolina&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Latino&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Not a resident of Union County or Mecklenburg County, North Carolina&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Carrizosa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carolinas Healthcare System, Levine Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Bawtinhimer, BSPH</last_name>
    <role>Study Director</role>
    <affiliation>Carolinas Healthcare System, Levine Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jim Symanowski, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Carolinas Healthcare System - Levine Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wake Forest University Health Sciences</investigator_affiliation>
    <investigator_full_name>Daniel Carrizosa</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Breast health education</keyword>
  <keyword>Latino women</keyword>
  <keyword>Group education</keyword>
  <keyword>Breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 24, 2018</submitted>
    <returned>September 21, 2018</returned>
    <submitted>July 1, 2019</submitted>
    <returned>August 9, 2019</returned>
    <submitted>June 30, 2021</submitted>
    <submission_canceled>June 30, 2021</submission_canceled>
    <submitted>October 4, 2022</submitted>
    <returned>August 21, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02205736
org study id: LCI-BRE-NOS-HEP-001
nct id: NCT02205736
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in baseline of breast cancer health literacy
time frame: 1 year
description: Analysis of pre-education and post-education questionnaires administered to subjects.
arm group label: Living Room Visit participants
arm group type: Other
description: Latino women who received breast health education while attending a Living Room Visit.
intervention type: Other
intervention name: Breast Health Education
description: Small group breast health educational sessions for Latino women in home setting.
arm group label: Living Room Visit participants
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Carrizosa, MD
role: Principal Investigator
affiliation: Carolinas Healthcare System, Levine Cancer Institute
last name: Anna Bawtinhimer, BSPH
role: Study Director
affiliation: Carolinas Healthcare System, Levine Cancer Institute
last name: Jim Symanowski, PhD
role: Study Director
affiliation: Carolinas Healthcare System - Levine Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wake Forest University Health Sciences
investigator full name: Daniel Carrizosa
investigator title: PI
mesh term: Breast Neoplasms
sharing ipd: No
submitted: January 24, 2018
returned: September 21, 2018
submitted: July 1, 2019
returned: August 9, 2019
submitted: June 30, 2021
submission canceled: June 30, 2021
submitted: October 4, 2022
returned: August 21, 2023