xml: <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/NCT06036875</url>
    </required_header>
    <id_info>
      <org_study_id>22-012888</org_study_id>
      <secondary_id>NCI-2023-04394</secondary_id>
      <secondary_id>22-012888</secondary_id>
      <nct_id>NCT06036875</nct_id>
    </id_info>
    <brief_title>CARE: Cancer Risk Perception and Women of Color</brief_title>
    <official_title>CARE: Cancer Risk Perception and Women of Color</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study examines patient understanding of current and lifetime risk for breast cancer in&#xD;
        women of color from diverse racial and ethnic backgrounds.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. Examine the association between BC risk factors and BC risk perceptions among younger&#xD;
        Black and Hispanic women and explore differences in associations by race and ethnicity (Black&#xD;
        Hispanic, Black, Hispanic).&#xD;
  &#xD;
        II. Explore how younger Black and Hispanic women conceptualize and formulate their risk for&#xD;
        BC and to explore the relationship between risk perceptions and risk-reduction strategies.&#xD;
  &#xD;
        OUTLINE: This is an observational study.&#xD;
  &#xD;
        Patients complete a survey and may participate in an interview on study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 23, 2023</start_date>
    <completion_date type="Anticipated">February 23, 2028</completion_date>
    <primary_completion_date type="Anticipated">February 23, 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Perception of risk</measure>
      <time_frame>Baseline (at enrollment)</time_frame>
      <description>Measured using a 0-100% response (percent lifetime risk) and a 5-point verbal scale ranging from 'very low' to 'very high' (ordinal lifetime risk). Participants will also be asked to assess their risk compared to women their age with the response options of 'much lower', 'about the same', and 'much higher' (comparative risk likelihood).</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">340</enrollment>
    <condition>Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>Health Services Research</arm_group_label>
      <description>Patients complete a survey and may participate in an interview on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non-Interventional Study</intervention_name>
      <description>Non-interventional study</description>
      <arm_group_label>Health Services Research</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Black and Hispanic women from Arizona and Florida&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-identify as female&#xD;
  &#xD;
            -  Between the ages of 25 and 50&#xD;
  &#xD;
            -  No medical history of breast cancer&#xD;
  &#xD;
            -  Reside in Arizona or Florida&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to understand or comprehend English or Spanish&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Self-identify as female</gender_description>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessica D Austin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic in Arizona</name>
        <address>
          <city>Scottsdale</city>
          <state>Arizona</state>
          <zip>85259</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica D. Austin, Ph.D.</last_name>
        <phone>480-301-4118</phone>
        <email>Austin.jessica2@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Jessica D. Austin, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224-9980</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Megan A. Allyse, Ph.D.</last_name>
        <phone>904-953-0368</phone>
        <email>Allyse.Megan@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Megan A. Allyse, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036875
  org study id: 22-012888
  secondary id: NCI-2023-04394
  secondary id: 22-012888
  nct id: NCT06036875
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study examines patient understanding of current and lifetime risk for breast cancer in
        women of color from diverse racial and ethnic backgrounds.
  PRIMARY OBJECTIVES:
  
        I. Examine the association between BC risk factors and BC risk perceptions among younger
        Black and Hispanic women and explore differences in associations by race and ethnicity (Black
        Hispanic, Black, Hispanic).
  
        II. Explore how younger Black and Hispanic women conceptualize and formulate their risk for
        BC and to explore the relationship between risk perceptions and risk-reduction strategies.
  
        OUTLINE: This is an observational study.
  
        Patients complete a survey and may participate in an interview on study.
  observational model: Ecologic or Community
  time perspective: Prospective
  measure: Perception of risk
  time frame: Baseline (at enrollment)
  description: Measured using a 0-100% response (percent lifetime risk) and a 5-point verbal scale ranging from 'very low' to 'very high' (ordinal lifetime risk). Participants will also be asked to assess their risk compared to women their age with the response options of 'much lower', 'about the same', and 'much higher' (comparative risk likelihood).
  arm group label: Health Services Research
  description: Patients complete a survey and may participate in an interview on study.
  intervention type: Other
  intervention name: Non-Interventional Study
  description: Non-interventional study
  arm group label: Health Services Research
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Self-identify as female
  minimum age: 25 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jessica D Austin
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Breast Neoplasms