<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/NCT03029286</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0687</org_study_id>
    <nct_id>NCT03029286</nct_id>
  </id_info>
  <brief_title>ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2</brief_title>
  <official_title>ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</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 trial will test a decision support web based intervention for women at increased risk&#xD;
      for breast cancer due to breast density and other risk factors (age, race/ethnicity, family&#xD;
      history of breast cancer, history of prior breast biopsies), and to consider MRI and/or&#xD;
      chemoprevention to manage their breast cancer risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Along with better-known risk factors such as family history having dense breasts is one of&#xD;
      the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of&#xD;
      women, with an additional third having heterogeneously dense breasts. Women in these&#xD;
      categories have 3-6 times the risk of breast cancer as compared to women with least density.&#xD;
      Although breast density is measured on routine screening mammograms, it is not typically&#xD;
      communicated to patients. This is changing as a result of legal mandates and approaches need&#xD;
      to be tested to effectively integrate this clinical information in care. Therefore,we have&#xD;
      developed an intervention to support decision making about cancer risk management (MRI and&#xD;
      chemoprevention) for women at clinically elevated risk using a web-based intervention that&#xD;
      will evaluate the efficacy of a web based intervention with personalized risk information&#xD;
      communication versus usual care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of chemoprevention gathered via health plan pharmacy records at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Chemoprevention (raloxifine or tamoxifen) gathered via health plan pharmacy records at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress gathered via self-report distress thermometer at 6-weeks and 12 months after recruitment</measure>
    <time_frame>6 weeks and 12 months</time_frame>
    <description>Distress via self-report distress thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast MRI gathered via health plan records at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Use of Breast MRI gathered via health plan records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">995</enrollment>
  <condition>Breast Density</condition>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Personalized Web Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Arm</intervention_name>
    <description>Health information provided by the American Cancer Society Website</description>
    <arm_group_label>Usual Care Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized Web Intervention Arm</intervention_name>
    <description>Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.</description>
    <arm_group_label>Personalized Web Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women, aged 40-69&#xD;
&#xD;
          -  Enrolled at Group Health&#xD;
&#xD;
          -  Have had a negative mammogram as part of their routine care&#xD;
&#xD;
          -  Either (a) an intermediate 5-year risk (&gt;1.67%-2.49%) and extremely dense breasts or&#xD;
             (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense&#xD;
             breasts utilizing the Breast Cancer Surveillance Consortium Risk Calculator&#xD;
             (http://tools.bcsc-scc.org/BC5yearRisk/)&#xD;
&#xD;
          -  Women must also have a valid email address.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to speak and read English&#xD;
&#xD;
          -  History of LCIS&#xD;
&#xD;
          -  Prior cancer diagnosis (including DCIS)&#xD;
&#xD;
          -  Known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling&#xD;
&#xD;
          -  Do not want to be contacted for research&#xD;
&#xD;
          -  Have previously participated in intervention development activities&#xD;
&#xD;
          -  Dis-enrolled from health plan between mammogram and start of recruitment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne C O'Neill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University/Lombardi Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen Wernli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Washington Health Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>28124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Suzanne C. O'Neill</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Breast Density</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>
  <!-- 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/NCT03029286
org study id: 2015-0687
nct id: NCT03029286
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial will test a decision support web based intervention for women at increased risk
      for breast cancer due to breast density and other risk factors (age, race/ethnicity, family
      history of breast cancer, history of prior breast biopsies), and to consider MRI and/or
      chemoprevention to manage their breast cancer risk.
Along with better-known risk factors such as family history having dense breasts is one of
      the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of
      women, with an additional third having heterogeneously dense breasts. Women in these
      categories have 3-6 times the risk of breast cancer as compared to women with least density.
      Although breast density is measured on routine screening mammograms, it is not typically
      communicated to patients. This is changing as a result of legal mandates and approaches need
      to be tested to effectively integrate this clinical information in care. Therefore,we have
      developed an intervention to support decision making about cancer risk management (MRI and
      chemoprevention) for women at clinically elevated risk using a web-based intervention that
      will evaluate the efficacy of a web based intervention with personalized risk information
      communication versus usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Uptake of chemoprevention gathered via health plan pharmacy records at 12 months
time frame: 12 months
description: Chemoprevention (raloxifine or tamoxifen) gathered via health plan pharmacy records at 12 months
measure: Distress gathered via self-report distress thermometer at 6-weeks and 12 months after recruitment
time frame: 6 weeks and 12 months
description: Distress via self-report distress thermometer
measure: Breast MRI gathered via health plan records at 12 months
time frame: 12 months
description: Use of Breast MRI gathered via health plan records
arm group label: Personalized Web Intervention Arm
arm group type: Experimental
description: Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
arm group label: Usual Care Arm
arm group type: Active Comparator
description: Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density.
intervention type: Behavioral
intervention name: Usual Care Arm
description: Health information provided by the American Cancer Society Website
arm group label: Usual Care Arm
intervention type: Behavioral
intervention name: Personalized Web Intervention Arm
description: Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
arm group label: Personalized Web Intervention Arm
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 69 Years
healthy volunteers: No
last name: Suzanne C O'Neill, PhD
role: Principal Investigator
affiliation: Georgetown University/Lombardi Comprehensive Cancer Center
last name: Karen Wernli, PhD
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Suzanne C. O'Neill
investigator title: Associate Professor
mesh term: Breast Neoplasms
sharing ipd: No