<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/NCT03775213</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101109</org_study_id>
    <secondary_id>4R00CA207872-03</secondary_id>
    <nct_id>NCT03775213</nct_id>
  </id_info>
  <brief_title>Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)</brief_title>
  <official_title>The Mathematics of Breast Cancer Overtreatment: Improving Treatment Choice Through Effective Communication of Personalized Cancer Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      The purpose of this research study is to evaluate a decision support tool for patients&#xD;
      diagnosed with ductal carcinoma in situ (DCIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ&#xD;
      (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional&#xD;
      endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM)&#xD;
      as an alternative to immediate surgery for select patient groups. Little is known about&#xD;
      women's acceptability of AM after a diagnosis with DCIS.&#xD;
&#xD;
      Here the study team seeks to answer the question: if AM is found to be a safe alternative to&#xD;
      immediate surgery, how likely are women to choose it as their first course of treatment?&#xD;
&#xD;
      In this study, women are asked to imagine having recently been diagnosed with DCIS. For some&#xD;
      in the intervention arm, in-depth information about surgical options and AM are presented&#xD;
      with a web-based decision support tool. After exploring the decision support tool,&#xD;
      participants are asked to make a hypothetical treatment choice and to answer a series of&#xD;
      additional questions about their decision-making process and personal preferences. Women in&#xD;
      the control arm receive a reduced version of the decision support tool that only provides&#xD;
      in-depth information about the surgical options (AM is mentioned as an experimental&#xD;
      approach).&#xD;
&#xD;
      The overarching hypothesis of this study is that patients who are offered AM as a&#xD;
      guideline-concordant care option (a potential future scenario if ongoing trials confirm the&#xD;
      safety of AM) are more likely to choose it compared to women in current clinical practice&#xD;
      (who receive information about surgical options only).&#xD;
&#xD;
      Primary research question: Compared to presenting active monitoring (AM) as an experimental&#xD;
      option, does presenting AM as a guideline-concordant care option increase its uptake as&#xD;
      treatment choice?&#xD;
&#xD;
      Secondary research questions: Compared to presenting active monitoring (AM) as an&#xD;
      experimental option, does presenting active monitoring as a guideline-concordant care option&#xD;
      increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy&#xD;
      as treatment choice?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2021</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Chose Active Monitoring (AM).</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Found the Treatment Option Acceptable.</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1=&quot;Not at all comfortable&quot; and 5=&quot;Very comfortable.&quot; The outcome was dichotomized using responses of 4 or 5 to represent &quot;Acceptable&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Perceived Active Monitoring as Risky.</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1=&quot;Not at all risky&quot; and 5=&quot;Very risky&quot;. The outcome was dichotomized using responses of 4 or 5 to represent &quot;Risky&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Chose Mastectomy.</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-perceived Knowledge About DCIS.</measure>
    <time_frame>Baseline and 1 hour</time_frame>
    <description>Measured pre- and post-tool as a categorical 5-point Likert scale from &quot;I know very little about DCIS&quot; (1) to &quot;I know a lot about DCIS&quot; (5); analyzed as continuous variable.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported Breast Cancer Knowledge</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured pre-tool as 5-point Likert scale from &quot;I know very little about breast cancer&quot; (1) to &quot;I know a lot about breast cancer&quot; (5); analyzed as continuous variable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Choice Reason</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as an open text field.</description>
  </other_outcome>
  <other_outcome>
    <measure>Choice Confidence (Chambers et al., 2012)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as categorical 5-point Likert scale from &quot;Not at all confident&quot; (1) to &quot;Very confident&quot; (5); analyzed as continuous variable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Information Needs Satisfaction (Adapted From Hess, 2012)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knowledge Scale (De Novo)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool (3 questions).</description>
  </other_outcome>
  <other_outcome>
    <measure>Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool (9 questions).</description>
  </other_outcome>
  <other_outcome>
    <measure>Preparation for Decision Making (PDMS) (Bennett, et al., 2010)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from &quot;Not at all&quot; (1) to &quot;A great deal&quot; (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability Question</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as an open text field.</description>
  </other_outcome>
  <other_outcome>
    <measure>Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as a 7-item scale, each item elicited on a scale from &quot;Rarely&quot; (1) to &quot;Often&quot; (3).</description>
  </other_outcome>
  <other_outcome>
    <measure>Short Graph Literacy (Okan et al., 2019)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total &quot;graph literacy score&quot; (0-4).</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical Maximizer Minimizer Scale (Scherer et al., 2020)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as categorical 6-point Likert scale from &quot;I strongly lean toward waiting and seeing&quot; (1) to &quot;I strongly lean toward taking action&quot; (6); analyzed as continuous variable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitude Toward Risk (Zhang et al., 2019)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from &quot;Strongly disagree&quot; (1) to &quot;Strongly agree&quot; (5).</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from &quot;Never&quot; (0) to &quot;Always&quot; (5).</description>
  </other_outcome>
  <other_outcome>
    <measure>Importance of Appearance (Borzekowski et al., 2000)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from &quot;Not at all important compared to other things in my life&quot; (1) to &quot;The very most important thing in my life&quot; (6).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cancer Fear (Lerman Worry Scale, 1991)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from &quot;Not at all&quot; (1) to &quot;Almost all the time&quot; (5)</description>
  </other_outcome>
  <other_outcome>
    <measure>Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>Self-reported health status (visual analog scale, 0-100).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">322</enrollment>
  <condition>Ductal Carcinoma in Situ</condition>
  <arm_group>
    <arm_group_label>Standard Treatment Options + Active Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Treatment Options</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants explore decision support tool that includes current standard treatment options for DCIS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Support Tool with Active Monitoring</intervention_name>
    <description>The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
    <arm_group_label>Standard Treatment Options + Active Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Support Tool without Active Monitoring</intervention_name>
    <description>The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
    <arm_group_label>Standard Treatment Options</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sex: Female&#xD;
&#xD;
          -  Age: 50-79 years&#xD;
&#xD;
          -  Has had a negative mammographic screen in the past 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc D Ryser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Mammography Clinic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <results_first_submitted>December 2, 2022</results_first_submitted>
  <results_first_submitted_qc>January 4, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2023</results_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ductal carcinoma in situ</keyword>
  <keyword>Decision support tool</keyword>
  <keyword>Informed decision-making</keyword>
  <keyword>Overtreatment</keyword>
  <keyword>Active surveillance</keyword>
  <keyword>Active monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 11, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03775213/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03775213/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03775213/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from Duke mammography clinics between October 2021 and January 2022. The first participant was enrolled on October 12th, 2021 and the last participant was enrolled on January 29th, 2022.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Treatment Options + Active Monitoring (AM)</title>
          <description>Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS), as well as active monitoring (AM).&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
        </group>
        <group group_id="P2">
          <title>Standard Treatment Options</title>
          <description>Participants explore decision support tool that includes current standard treatment options for ductal carcinoma in situ (DCIS).&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incomplete Survey</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Treatment Options + Active Monitoring</title>
          <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
        </group>
        <group group_id="B2">
          <title>Standard Treatment Options</title>
          <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="102"/>
            <count group_id="B3" value="204"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="57" upper_limit="69"/>
                    <measurement group_id="B2" value="62" lower_limit="56" upper_limit="67"/>
                    <measurement group_id="B3" value="62" lower_limit="57" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>50-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="204"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>In Relationship</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Separated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Single</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Some High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bachelor's Degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Master's Degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Professional Degree (e.g., MD, JD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctorate Degree (e.g., PhD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Finances</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Extra for special</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Just enough</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cut back to pay bills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficulty paying bills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Reported Health Status, Median (Q1, Q3)</title>
          <description>Self-Reported Health Status measured on a visual analog scale (0-100%), with 0 being the worst outcome and 100 being the best outcome.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83" lower_limit="75" upper_limit="90"/>
                    <measurement group_id="B2" value="85" lower_limit="75" upper_limit="90"/>
                    <measurement group_id="B3" value="83.5" lower_limit="75" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Personal Cancer History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family Cancer History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maximizer Minimizer Scale, Median (Q1, Q3)</title>
          <description>This categorical 6-point Likert scale ranges from &quot;I strongly lean toward waiting and seeing&quot; (1) to &quot;I strongly lean toward taking action&quot; (6). The scale captures the extent to which individuals are &quot;medical maximizers&quot; who are predisposed to seek health care even for minor problems, versus &quot;medical minimizers&quot; who prefer to avoid medical intervention unless it is necessary.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" lower_limit="2.0" upper_limit="5.0"/>
                    <measurement group_id="B2" value="4.0" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="B3" value="4.0" lower_limit="2.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Graph Literacy Score (0-3), Median (Q1, Q3)</title>
          <description>Single score derived from 3 items, each scored as correct or incorrect. Correct answers are summed for a total &quot;graph literacy score&quot; (0-3). Lower scores indicate worse outcomes, and higher scores indicate better outcomes.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="B2" value="2.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="B3" value="2.0" lower_limit="2.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-tool Knowledge (1-5): Breast Cancer</title>
          <description>5-point Likert scale from &quot;I know very little about breast cancer&quot; (1) to &quot;I know a lot about breast cancer&quot; (5).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="B2" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="B3" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-tool Knowledge (1-5): DCIS</title>
          <description>5-point Likert scale from &quot;I know very little about DCIS&quot; (1) to &quot;I know a lot about DCIS&quot; (5).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="B2" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="B3" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Chose Active Monitoring (AM).</title>
        <description>Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.</description>
        <time_frame>Up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Treatment Options + Active Monitoring</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Options</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Chose Active Monitoring (AM).</title>
          <description>Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.91</ci_lower_limit>
            <ci_upper_limit>2.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Found the Treatment Option Acceptable.</title>
        <description>Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1=&quot;Not at all comfortable&quot; and 5=&quot;Very comfortable.&quot; The outcome was dichotomized using responses of 4 or 5 to represent &quot;Acceptable&quot;.</description>
        <time_frame>Up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Treatment Options + Active Monitoring</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Options</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Found the Treatment Option Acceptable.</title>
          <description>Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1=&quot;Not at all comfortable&quot; and 5=&quot;Very comfortable.&quot; The outcome was dichotomized using responses of 4 or 5 to represent &quot;Acceptable&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Active Monitoring</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumpectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumpectomy with Radiation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mastectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Active Monitoring</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.49</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Lumpectomy</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.79</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Lumpectomy with Radiation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.62</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mastectomy</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.48</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Perceived Active Monitoring as Risky.</title>
        <description>Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1=&quot;Not at all risky&quot; and 5=&quot;Very risky&quot;. The outcome was dichotomized using responses of 4 or 5 to represent &quot;Risky&quot;.</description>
        <time_frame>Up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Treatment Options + Active Monitoring</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Options</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Perceived Active Monitoring as Risky.</title>
          <description>Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1=&quot;Not at all risky&quot; and 5=&quot;Very risky&quot;. The outcome was dichotomized using responses of 4 or 5 to represent &quot;Risky&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.59</ci_lower_limit>
            <ci_upper_limit>1.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Chose Mastectomy.</title>
        <description>Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.</description>
        <time_frame>Up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Treatment Options + Active Monitoring</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Options</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Chose Mastectomy.</title>
          <description>Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.65</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-perceived Knowledge About DCIS.</title>
        <description>Measured pre- and post-tool as a categorical 5-point Likert scale from &quot;I know very little about DCIS&quot; (1) to &quot;I know a lot about DCIS&quot; (5); analyzed as continuous variable.</description>
        <time_frame>Baseline and 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Treatment Options + Active Monitoring</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Options</title>
            <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-perceived Knowledge About DCIS.</title>
          <description>Measured pre- and post-tool as a categorical 5-point Likert scale from &quot;I know very little about DCIS&quot; (1) to &quot;I know a lot about DCIS&quot; (5); analyzed as continuous variable.</description>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="2.5" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Slope</param_type>
            <param_value>.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-.20</ci_lower_limit>
            <ci_upper_limit>.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Self-reported Breast Cancer Knowledge</title>
        <description>Measured pre-tool as 5-point Likert scale from &quot;I know very little about breast cancer&quot; (1) to &quot;I know a lot about breast cancer&quot; (5); analyzed as continuous variable.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Treatment Choice Reason</title>
        <description>Measured post-tool as an open text field.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Choice Confidence (Chambers et al., 2012)</title>
        <description>Measured post-tool as categorical 5-point Likert scale from &quot;Not at all confident&quot; (1) to &quot;Very confident&quot; (5); analyzed as continuous variable.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Information Needs Satisfaction (Adapted From Hess, 2012)</title>
        <description>Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Knowledge Scale (De Novo)</title>
        <description>Measured post-tool (3 questions).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)</title>
        <description>Measured post-tool (9 questions).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Preparation for Decision Making (PDMS) (Bennett, et al., 2010)</title>
        <description>Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from &quot;Not at all&quot; (1) to &quot;A great deal&quot; (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Usability Question</title>
        <description>Measured post-tool as an open text field.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)</title>
        <description>Measured post-tool as a 7-item scale, each item elicited on a scale from &quot;Rarely&quot; (1) to &quot;Often&quot; (3).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Short Graph Literacy (Okan et al., 2019)</title>
        <description>Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total &quot;graph literacy score&quot; (0-4).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Medical Maximizer Minimizer Scale (Scherer et al., 2020)</title>
        <description>Measured post-tool as categorical 6-point Likert scale from &quot;I strongly lean toward waiting and seeing&quot; (1) to &quot;I strongly lean toward taking action&quot; (6); analyzed as continuous variable.</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Attitude Toward Risk (Zhang et al., 2019)</title>
        <description>Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from &quot;Strongly disagree&quot; (1) to &quot;Strongly agree&quot; (5).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)</title>
        <description>Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from &quot;Never&quot; (0) to &quot;Always&quot; (5).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Importance of Appearance (Borzekowski et al., 2000)</title>
        <description>Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from &quot;Not at all important compared to other things in my life&quot; (1) to &quot;The very most important thing in my life&quot; (6).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cancer Fear (Lerman Worry Scale, 1991)</title>
        <description>Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from &quot;Not at all&quot; (1) to &quot;Almost all the time&quot; (5)</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)</title>
        <description>Self-reported health status (visual analog scale, 0-100).</description>
        <time_frame>Up to 1 hour</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Treatment Options + Active Monitoring</title>
          <description>Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.&#xD;
Decision Support Tool with Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.</description>
        </group>
        <group group_id="E2">
          <title>Standard Treatment Options</title>
          <description>Participants explore decision support tool that includes current standard treatment options for DCIS.&#xD;
Decision Support Tool without Active Monitoring: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Marc D. Ryser</name_or_title>
      <organization>Duke University</organization>
      <phone>(919) 684 8294</phone>
      <email>marc.ryser@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03775213
org study id: Pro00101109
secondary id: 4R00CA207872-03
nct id: NCT03775213
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to evaluate a decision support tool for patients
      diagnosed with ductal carcinoma in situ (DCIS).
Today, guideline concordant care options for patients diagnosed with ductal carcinoma in situ
      (DCIS) are lumpectomy (with or without radiation treatment) and mastectomy, with optional
      endocrine therapy. Several ongoing trials are evaluating the safety of active monitoring (AM)
      as an alternative to immediate surgery for select patient groups. Little is known about
      women's acceptability of AM after a diagnosis with DCIS.

      Here the study team seeks to answer the question: if AM is found to be a safe alternative to
      immediate surgery, how likely are women to choose it as their first course of treatment?

      In this study, women are asked to imagine having recently been diagnosed with DCIS. For some
      in the intervention arm, in-depth information about surgical options and AM are presented
      with a web-based decision support tool. After exploring the decision support tool,
      participants are asked to make a hypothetical treatment choice and to answer a series of
      additional questions about their decision-making process and personal preferences. Women in
      the control arm receive a reduced version of the decision support tool that only provides
      in-depth information about the surgical options (AM is mentioned as an experimental
      approach).

      The overarching hypothesis of this study is that patients who are offered AM as a
      guideline-concordant care option (a potential future scenario if ongoing trials confirm the
      safety of AM) are more likely to choose it compared to women in current clinical practice
      (who receive information about surgical options only).

      Primary research question: Compared to presenting active monitoring (AM) as an experimental
      option, does presenting AM as a guideline-concordant care option increase its uptake as
      treatment choice?

      Secondary research questions: Compared to presenting active monitoring (AM) as an
      experimental option, does presenting active monitoring as a guideline-concordant care option
      increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy
      as treatment choice?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Number of Participants Who Chose Active Monitoring (AM).
time frame: Up to 1 hour
description: Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.
measure: Number of Participants Who Found the Treatment Option Acceptable.
time frame: Up to 1 hour
description: Acceptability was ascertained using 1-5 Likert scale. Acceptability, asked in terms of comfort with a given treatment choice, was anchored at 1="Not at all comfortable" and 5="Very comfortable." The outcome was dichotomized using responses of 4 or 5 to represent "Acceptable".
measure: Number of Participants Who Perceived Active Monitoring as Risky.
time frame: Up to 1 hour
description: Perceived risk outcome was ascertained using 1-5 Likert scale. Perceived risk was asked for active monitoring only, and was anchored at 1="Not at all risky" and 5="Very risky". The outcome was dichotomized using responses of 4 or 5 to represent "Risky".
measure: Number of Participants Who Chose Mastectomy.
time frame: Up to 1 hour
description: Presented to participants as a categorical item: active monitoring, lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: mastectomy vs non-mastectomy.
measure: Change in Self-perceived Knowledge About DCIS.
time frame: Baseline and 1 hour
description: Measured pre- and post-tool as a categorical 5-point Likert scale from "I know very little about DCIS" (1) to "I know a lot about DCIS" (5); analyzed as continuous variable.
measure: Self-reported Breast Cancer Knowledge
time frame: Up to 1 hour
description: Measured pre-tool as 5-point Likert scale from "I know very little about breast cancer" (1) to "I know a lot about breast cancer" (5); analyzed as continuous variable.
measure: Treatment Choice Reason
time frame: Up to 1 hour
description: Measured post-tool as an open text field.
measure: Choice Confidence (Chambers et al., 2012)
time frame: Up to 1 hour
description: Measured post-tool as categorical 5-point Likert scale from "Not at all confident" (1) to "Very confident" (5); analyzed as continuous variable.
measure: Information Needs Satisfaction (Adapted From Hess, 2012)
time frame: Up to 1 hour
description: Measured post-tool as 4-item scale, each item elicited on a 7-point Likert scale; items analyzed separately as continuous variables.
measure: Knowledge Scale (De Novo)
time frame: Up to 1 hour
description: Measured post-tool (3 questions).
measure: Knowledge Scale: Decision Quality Instrument (Adapted From Sepucha, et al., 2019)
time frame: Up to 1 hour
description: Measured post-tool (9 questions).
measure: Preparation for Decision Making (PDMS) (Bennett, et al., 2010)
time frame: Up to 1 hour
description: Measured post-tool as 9-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "A great deal" (5); for each participant, the average score across 9 items is recorded and analyzed as a continuous variable.
measure: Usability Question
time frame: Up to 1 hour
description: Measured post-tool as an open text field.
measure: Aspects of Health Literacy Scale (AAHLS) (Chinn et al., 2013)
time frame: Up to 1 hour
description: Measured post-tool as a 7-item scale, each item elicited on a scale from "Rarely" (1) to "Often" (3).
measure: Short Graph Literacy (Okan et al., 2019)
time frame: Up to 1 hour
description: Measured post-tool. Single score derived from 4 items, each scored as correct or incorrect. Correct answers are summed for a total "graph literacy score" (0-4).
measure: Medical Maximizer Minimizer Scale (Scherer et al., 2020)
time frame: Up to 1 hour
description: Measured post-tool as categorical 6-point Likert scale from "I strongly lean toward waiting and seeing" (1) to "I strongly lean toward taking action" (6); analyzed as continuous variable.
measure: Attitude Toward Risk (Zhang et al., 2019)
time frame: Up to 1 hour
description: Measured post-tool as an 8-item scale, each item elicited on a 5-point Likert scale from "Strongly disagree" (1) to "Strongly agree" (5).
measure: Pain Tolerance (McCracken et al., 1992; Two Questions From Each Subscale)
time frame: Up to 1 hour
description: Measured post-tool as an 4-item scale, each item elicited on a 6-point Likert scale from "Never" (0) to "Always" (5).
measure: Importance of Appearance (Borzekowski et al., 2000)
time frame: Up to 1 hour
description: Measured post-tool as a 4-item scale, each item elicited on a 6-point Likert scale from "Not at all important compared to other things in my life" (1) to "The very most important thing in my life" (6).
measure: Cancer Fear (Lerman Worry Scale, 1991)
time frame: Up to 1 hour
description: Measured post-tool as a 3-item scale, each item elicited on a 5-point Likert scale from "Not at all" (1) to "Almost all the time" (5)
measure: Current Health: Visual Analog Scale (Adapted From EQ-5D-3L, EuroQol Group, 1990)
time frame: Up to 1 hour
description: Self-reported health status (visual analog scale, 0-100).
arm group label: Standard Treatment Options + Active Monitoring
arm group type: Experimental
description: Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.
arm group label: Standard Treatment Options
arm group type: Active Comparator
description: Participants explore decision support tool that includes current standard treatment options for DCIS.
intervention type: Behavioral
intervention name: Decision Support Tool with Active Monitoring
description: The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
arm group label: Standard Treatment Options + Active Monitoring
intervention type: Behavioral
intervention name: Decision Support Tool without Active Monitoring
description: The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
arm group label: Standard Treatment Options
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc D Ryser, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Intraductal, Noninfiltrating
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 