<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/NCT02986360</url>
  </required_header>
  <id_info>
    <org_study_id>2016P001411</org_study_id>
    <nct_id>NCT02986360</nct_id>
  </id_info>
  <brief_title>Informed Implementation of Breast Density Reporting</brief_title>
  <official_title>Informed Implementation of Breast Density Reporting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      1. To develop brief informational videos, Vidscrips, that can be sent to women following&#xD;
           their mammogram to provide personalized information that integrates breast density with&#xD;
           overall breast cancer risk, and provides information about additional care&#xD;
           recommendations and talking tips for conversations with the health care providers.&#xD;
&#xD;
        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.&#xD;
           The investigators hypothesize that individuals in the intervention arm (vs. those in the&#xD;
           standard care arm who receive a letter with the language required by the legislation)&#xD;
           will have more accurate knowledge of their overall risk of breast cancer, their&#xD;
           Mammographic Breast Density (MBD) result, more appropriate observed and intended use of&#xD;
           additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be&#xD;
           reserved only for women at high risk of breast cancer], better satisfaction with their&#xD;
           episode of breast cancer screening, less decisional conflict about their personal&#xD;
           decision for any additional evaluation, and less worry about breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of overall breast cancer risk</measure>
    <time_frame>1 month</time_frame>
    <description>electronic questionnaire developed by research staff</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge of breast density</measure>
    <time_frame>1 month</time_frame>
    <description>electronic questionnaire developed by research staff</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observed use of additional screening</measure>
    <time_frame>9 months of index mammogram</time_frame>
    <description>Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Breast Density, Breast Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>Vidscrip educational video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vidscrip educational video</intervention_name>
    <description>Vidscrip educational video provide to women</description>
    <arm_group_label>Vidscrip educational video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing screening mammography at participating hospital facility&#xD;
&#xD;
          -  normal mammogram result&#xD;
&#xD;
          -  no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer&#xD;
&#xD;
          -  must have email account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-English speaking&#xD;
&#xD;
          -  prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer&#xD;
&#xD;
          -  no email&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer S Haas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>September 20, 2018</last_update_submitted>
  <last_update_submitted_qc>September 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Jennifer S. Haas, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986360
org study id: 2016P001411
nct id: NCT02986360
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. To develop brief informational videos, Vidscrips, that can be sent to women following
           their mammogram to provide personalized information that integrates breast density with
           overall breast cancer risk, and provides information about additional care
           recommendations and talking tips for conversations with the health care providers.

        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.
           The investigators hypothesize that individuals in the intervention arm (vs. those in the
           standard care arm who receive a letter with the language required by the legislation)
           will have more accurate knowledge of their overall risk of breast cancer, their
           Mammographic Breast Density (MBD) result, more appropriate observed and intended use of
           additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be
           reserved only for women at high risk of breast cancer], better satisfaction with their
           episode of breast cancer screening, less decisional conflict about their personal
           decision for any additional evaluation, and less worry about breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Knowledge of overall breast cancer risk
time frame: 1 month
description: electronic questionnaire developed by research staff
measure: Knowledge of breast density
time frame: 1 month
description: electronic questionnaire developed by research staff
measure: Observed use of additional screening
time frame: 9 months of index mammogram
description: Additional screening tests (ultrasound or MRI) extracted from patient's electronic medical record
arm group label: Vidscrip educational video
arm group type: Active Comparator
description: Patients receive Vidscrip education video discussing breast density in the context of their normal mammogram result
arm group label: Standard of care
arm group type: No Intervention
description: Receive normal mammogram result and standard letter about breast density without any additional educational tools to contextualize breast density
intervention type: Behavioral
intervention name: Vidscrip educational video
description: Vidscrip educational video provide to women
arm group label: Vidscrip educational video
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer S Haas, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Jennifer S. Haas, MD
investigator title: Professor of Medicine
sharing ipd: No