<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/NCT02248662</url>
  </required_header>
  <id_info>
    <org_study_id>12-420</org_study_id>
    <secondary_id>CE-12-11-4173</secondary_id>
    <nct_id>NCT02248662</nct_id>
  </id_info>
  <brief_title>Impact of Radiation Therapy on Breast Conservation in DCIS</brief_title>
  <official_title>Impact of Radiation Therapy on Breast Conservation in DCIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Large regional variation exists in the use of radiotherapy after breast-conserving surgery&#xD;
      (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial&#xD;
      radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast&#xD;
      event, many undergo mastectomy instead.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and their physicians are often confronted with a decision between more intensive&#xD;
      versus less intensive treatment for a particular diagnosis. Quality decision-making between&#xD;
      these options requires careful balancing of the risks and side-effects, as well as weighing&#xD;
      the expected outcomes and their associated value as assessed by the patient.&#xD;
&#xD;
      Although the incidence of DCIS has risen dramatically (1), there exists considerable debate&#xD;
      about optimal treatment. In general, people with DCIS have high rates of recurrence-free&#xD;
      survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or&#xD;
      radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but&#xD;
      have not been shown to improve survival.(6) In addition, radiation usually necessitates&#xD;
      mastectomy should a new cancer or DCIS develop in the same breast at any point during the&#xD;
      patient's lifetime. Patients also have a small chance of experiencing long-term toxicity.&#xD;
      Previous radiation can also complicate reconstructive options following mastectomy. The&#xD;
      tradeoff between risk of second breast diagnosis and side-effects and potential consequences&#xD;
      of radiation therapy underscores the need for patient preference-driven decision making.&#xD;
&#xD;
      Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if&#xD;
      they have a second breast event in the same breast. One study suggests that some women choose&#xD;
      not to have radiation after DCIS because they want to preserve a breast-preservation option&#xD;
      should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS&#xD;
      at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a&#xD;
      woman receives repeat breast-conserving surgery for a new diagnosis may not only be a&#xD;
      function of the stage of diagnosis, but may be also determined by the regional treatment&#xD;
      patterns used for management of DCIS. We sought to study whether regional intensity of&#xD;
      radiation use for DCIS treatment increases the likelihood of mastectomy at time of second&#xD;
      breast event, among women who have not received radiation therapy at initial DCIS diagnosis.&#xD;
      (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma&#xD;
      In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July&#xD;
      21, 2016.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS</measure>
    <time_frame>20 Years</time_frame>
    <description>The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the &quot;high&quot; cluster; those with the lowest proportions to the &quot;low&quot; cluster; and those in the between to the &quot;medium&quot; cluster.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3436</enrollment>
  <condition>DCIS</condition>
  <arm_group>
    <arm_group_label>Surveillance, Epidemiology, and End Results (SEER) Database</arm_group_label>
    <description>Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surveillance, Epidemiology, and End Results (SEER)-Medicare</arm_group_label>
    <description>Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women identified from SEER and SEER-Medicare data with Stage 0-III breast cancer after DCIS&#xD;
        who had received BCS without radiation for initial treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        This study used data from SEER and SEER-Medicare.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rinaa S. Punglia, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Pilgrim Health Care Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth College</name>
      <address>
        <city>Hanover</city>
        <state>New Hampshire</state>
        <zip>03755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sumner WE 3rd, Koniaris LG, Snell SE, Spector S, Powell J, Avisar E, Moffat F, Livingstone AS, Franceschi D. Results of 23,810 cases of ductal carcinoma-in-situ. Ann Surg Oncol. 2007 May;14(5):1638-43. doi: 10.1245/s10434-006-9316-1. Epub 2007 Jan 24.</citation>
    <PMID>17245612</PMID>
  </reference>
  <reference>
    <citation>Kim SY, Han BK, Kim EK, Choi WJ, Choi Y, Kim HH, Moon WK. Breast Cancer Detected at Screening US: Survival Rates and Clinical-Pathologic and Imaging Factors Associated with Recurrence. Radiology. 2017 Aug;284(2):354-364. doi: 10.1148/radiol.2017162348. Epub 2017 Apr 6.</citation>
    <PMID>28387638</PMID>
  </reference>
  <reference>
    <citation>EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.</citation>
    <PMID>16801628</PMID>
  </reference>
  <reference>
    <citation>Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2.</citation>
    <PMID>11498833</PMID>
  </reference>
  <reference>
    <citation>Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.</citation>
    <PMID>16864166</PMID>
  </reference>
  <reference>
    <citation>Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7.</citation>
    <PMID>12867108</PMID>
  </reference>
  <reference>
    <citation>Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039.</citation>
    <PMID>20956824</PMID>
  </reference>
  <reference>
    <citation>Kaplan CP, Napoles AM, Hwang ES, Bloom J, Stewart S, Nickleach D, Karliner L. Selection of treatment among Latina and non-Latina white women with ductal carcinoma in situ. J Womens Health (Larchmt). 2011 Feb;20(2):215-23. doi: 10.1089/jwh.2010.1986. Epub 2010 Dec 3.</citation>
    <PMID>21128819</PMID>
  </reference>
  <reference>
    <citation>Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.</citation>
    <PMID>9469327</PMID>
  </reference>
  <reference>
    <citation>Fong J, Kurniawan ED, Rose AK, Mou A, Collins JP, Miller JA, Mann GB. Outcomes of screening-detected ductal carcinoma in situ treated with wide excision alone. Ann Surg Oncol. 2011 Dec;18(13):3778-84. doi: 10.1245/s10434-011-1748-6. Epub 2011 Jun 1.</citation>
    <PMID>21630124</PMID>
  </reference>
  <reference>
    <citation>Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.</citation>
    <PMID>16461781</PMID>
  </reference>
  <reference>
    <citation>Pickle LW, MungioleM, Jones GK, White AA. Atlas of United States Mortality. Hyattsville, MD: Centers for Disease Control and Prevention; December 1996. http://www.cdc.gov/nchs/data/misc/atlasmet.pdf. Accessed September 1, 2015.</citation>
  </reference>
  <reference>
    <citation>Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicare reform. Health Aff (Millwood). 2002 Jul-Dec;Suppl Web Exclusives:W96-114. doi: 10.1377/hlthaff.w2.96.</citation>
    <PMID>12703563</PMID>
  </reference>
  <reference>
    <citation>Jagsi R, Abrahamse P, Hawley ST, Graff JJ, Hamilton AS, Katz SJ. Underascertainment of radiotherapy receipt in Surveillance, Epidemiology, and End Results registry data. Cancer. 2012 Jan 15;118(2):333-41. doi: 10.1002/cncr.26295. Epub 2011 Jun 29.</citation>
    <PMID>21717446</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>July 25, 2017</results_first_submitted>
  <results_first_submitted_qc>September 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2019</results_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Rinaa Punglia, MD MPH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>DCIS</keyword>
  <keyword>PCORI</keyword>
  <keyword>ductal carcinoma in situ</keyword>
  <keyword>radiation</keyword>
  <keyword>oncology</keyword>
  <keyword>patient-centered</keyword>
  <keyword>decision aid</keyword>
  <keyword>decision-making</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The computer model included data from sources including the NSABP B-17 and B-24 trials; the UK, Australia, and New Zealand ductal carcinoma in situ (DCIS) trial; an observational study of newly diagnosed patients with DCIS treated in British Columbia; and SEER databases. The researchers also conducted two retrospective studies.</recruitment_details>
      <pre_assignment_details>Originally, 38,514 total records from each database used for this study were screened for enrollment into the final cohort. After eligibility criteria were applied to the sample, the final sample size was 3,436.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Surveillance Epidemiology and End Results (SEER)-Medicare</title>
          <description>SEER-Medicare diagnoses from 1990-2009 linked to Medicare claims through 2010&#xD;
Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer</description>
        </group>
        <group group_id="P2">
          <title>Surveillance Epidemiology and End Results (SEER)</title>
          <description>Data was collected from the Surveillance Epidemiology and End Results (SEER) database on patients with ductal carcinoma in situ (DCIS) between 1990 and 2011.&#xD;
Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5320"/>
                <participants group_id="P2" count="33194"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="757"/>
                <participants group_id="P2" count="2679"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4563"/>
                <participants group_id="P2" count="30515"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SEER</title>
          <description>Data was collected from the Surveillance Epidemiology and End Results database on patients with DCIS between 1990 and 2011.</description>
        </group>
        <group group_id="B2">
          <title>SEER-Medicare</title>
          <description>SEER-Medicaid diagnoses from 1990-2009 linked to Medicare claims through 2010</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="2679"/>
            <count group_id="B2" value="757"/>
            <count group_id="B3" value="3436"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age at Secondary Diagnosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="363"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="363"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50 to 59 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="605"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="605"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 to 69 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="679"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="742"/>
                  </measurement_list>
                </category>
                <category>
                  <title>70 to 90 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1032"/>
                    <measurement group_id="B2" value="694"/>
                    <measurement group_id="B3" value="1726"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2679"/>
                    <measurement group_id="B2" value="757"/>
                    <measurement group_id="B3" value="3436"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="258"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2463"/>
                    <measurement group_id="B2" value="715"/>
                    <measurement group_id="B3" value="3178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2133"/>
                    <measurement group_id="B2" value="658"/>
                    <measurement group_id="B3" value="2791"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="283"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="347"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="263"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Household Income Within Census Data Quintiles</title>
          <description>Participants' median income levels were assessed using US Census Data. Income data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest socioeconomic status (quintile 1) to highest socioeconomic status (quintile 5).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1 (lowest)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="763"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="301"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="461"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="608"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="741"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 (highest)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="546"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants in Education Levels Within Census Data Quintiles</title>
          <description>Participants' education levels were assessed using US Census Data. Education data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest education level (quintile 1) to highest education level (quintile 5).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1 (lowest)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="664"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="490"/>
                    <measurement group_id="B2" value="167"/>
                    <measurement group_id="B3" value="657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="459"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="514"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 (highest)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="552"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Residence</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Urban</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2560"/>
                    <measurement group_id="B2" value="701"/>
                    <measurement group_id="B3" value="3261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rural</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with a Secondary SEER Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="370"/>
                    <measurement group_id="B3" value="370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2679"/>
                    <measurement group_id="B2" value="387"/>
                    <measurement group_id="B3" value="3066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Secondary SEER Diagnoses and Staging</title>
          <description>For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The number of cases who had a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387. Staging in the SEER and SEER-Medicare data registries is consistent with general cancer staging. Higher stages indicate worse outcomes.</description>
          <population>The number of cases with a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ductal carcinoma in situ (DCIS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="843"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1185"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="1362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage II-III</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="523"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with ER Status for Secondary SEER Diagnosis</title>
          <description>For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The total number of cases who had ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ER positive or negative. Therefore, the total number of SEER-Medicare cases in the final analysis was 387.</description>
          <population>The total number of cases with ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was unclear whether the diagnosis was ER+ or ER-.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1675"/>
                    <measurement group_id="B2" value="227"/>
                    <measurement group_id="B3" value="1902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="324"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="680"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="798"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Laterality for Secondary SEER Diagnosis</title>
          <description>For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with laterality information. The total number of cases who had laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral. Therefore, the total number of SEER-Medicare cases in the final analysis was 387.</description>
          <population>The total number of cases with laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ipsilateral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1619"/>
                    <measurement group_id="B2" value="239"/>
                    <measurement group_id="B3" value="1858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Contralateral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="387"/>
                    <count group_id="B3" value="3066"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1060"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="1208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Year of secondary diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1990-1995</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1996-2000</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="426"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2001-2005</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="778"/>
                    <measurement group_id="B2" value="263"/>
                    <measurement group_id="B3" value="1041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2006-2011</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1342"/>
                    <measurement group_id="B2" value="319"/>
                    <measurement group_id="B3" value="1661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interval between diagnoses</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.6" lower_limit="2.3" upper_limit="7.6"/>
                    <measurement group_id="B2" value="2.4" lower_limit="1.1" upper_limit="4.6"/>
                    <measurement group_id="B3" value="NA" lower_limit="NA" upper_limit="NA">This data was not calculated and was not included in the final, published article. The raw data was from SEER, and is no longer available to calculate this value because our data usage agreement with SEER expired.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Treatment intensity for primary DCIS</title>
          <description>Regional treatment intensity was measured by using health service areas (HSAs). HSAs were assiged to 1 of 3 clusters based on the observed proportion of radiotherapy used as coded by SEER and SEER-Medicare. The HSAs with the highest proportion of patients receiving radiotherapy were assigned to the high cluster; those with the lowest to the low cluster. This table shows how many people lived in each HSA.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Low (HSAs with lowest proportion receiving RT)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="966"/>
                    <measurement group_id="B2" value="261"/>
                    <measurement group_id="B3" value="1227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="885"/>
                    <measurement group_id="B2" value="274"/>
                    <measurement group_id="B3" value="1159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High (HSAs with highest proportion receiving RT)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2679"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="3436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="828"/>
                    <measurement group_id="B2" value="222"/>
                    <measurement group_id="B3" value="1050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson comorbidity score</title>
          <description>The Charlson comorbidity score is used to predict the risk of death within 1 year of hospitalization for patients with specific comorbid conditions. A high score indicates increased risk.</description>
          <population>Data was not collected for the SEER group and the data is no longer available to us.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0-1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="686"/>
                    <measurement group_id="B3" value="686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Distance to nearest radiation facility</title>
          <population>Data was not collected for the SEER group and is no longer available to us.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;10 miles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="634"/>
                    <measurement group_id="B3" value="634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10+ miles</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chemotherapy for secondary breast event</title>
          <population>Data was not collected for the SEER group and the data is no longer available to us.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="719"/>
                    <measurement group_id="B3" value="719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MRI in 6 months before secondary breast event</title>
          <population>Data was not collected for the SEER group and the data is no longer available to us.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="706"/>
                    <measurement group_id="B3" value="706"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="757"/>
                    <count group_id="B3" value="757"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS</title>
        <description>The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the &quot;high&quot; cluster; those with the lowest proportions to the &quot;low&quot; cluster; and those in the between to the &quot;medium&quot; cluster.</description>
        <time_frame>20 Years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SEER - Low Treatment Cluster</title>
            <description>Low treatment intensity for primary DCIS</description>
          </group>
          <group group_id="O2">
            <title>SEER-Medium Treatment Cluster</title>
            <description>Medium treatment intensity for primary DCIS</description>
          </group>
          <group group_id="O3">
            <title>SEER - High Treatment Cluster</title>
            <description>High treatment intensity for primary DCIS</description>
          </group>
          <group group_id="O4">
            <title>SEER-Medicare - Low Treatment Cluster</title>
            <description>Low treatment intensity for primary DCIS</description>
          </group>
          <group group_id="O5">
            <title>SEER-Medicare - Medium Treatment Cluster</title>
            <description>Medium treatment intensity for primary DCIS</description>
          </group>
          <group group_id="O6">
            <title>SEER Medicare - High Treatment Cluster</title>
            <description>High treatment intensity for primary DCIS</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS</title>
          <description>The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the &quot;high&quot; cluster; those with the lowest proportions to the &quot;low&quot; cluster; and those in the between to the &quot;medium&quot; cluster.</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="966"/>
                <count group_id="O2" value="885"/>
                <count group_id="O3" value="828"/>
                <count group_id="O4" value="222"/>
                <count group_id="O5" value="274"/>
                <count group_id="O6" value="261"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age at secondary diagnosis: &lt;50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="115"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at secondary diagnosis:50 to 59</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="230"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at secondary diagnosis: 60 to 69</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="221"/>
                    <measurement group_id="O3" value="232"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age at secondary diagnosis: 70 to 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="377"/>
                    <measurement group_id="O2" value="318"/>
                    <measurement group_id="O3" value="339"/>
                    <measurement group_id="O4" value="211"/>
                    <measurement group_id="O5" value="255"/>
                    <measurement group_id="O6" value="230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race: White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="715"/>
                    <measurement group_id="O2" value="752"/>
                    <measurement group_id="O3" value="662"/>
                    <measurement group_id="O4" value="191"/>
                    <measurement group_id="O5" value="252"/>
                    <measurement group_id="O6" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race: Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race: Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="831"/>
                    <measurement group_id="O2" value="823"/>
                    <measurement group_id="O3" value="811"/>
                    <measurement group_id="O4" value="206"/>
                    <measurement group_id="O5" value="258"/>
                    <measurement group_id="O6" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median income: Quintile 1 (lowest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="108"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median income: Quintile 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="190"/>
                    <measurement group_id="O4" value="33"/>
                    <measurement group_id="O5" value="71"/>
                    <measurement group_id="O6" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median income: Quintile 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="212"/>
                    <measurement group_id="O3" value="215"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="63"/>
                    <measurement group_id="O6" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median income: Quintile 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="221"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="40"/>
                    <measurement group_id="O5" value="52"/>
                    <measurement group_id="O6" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median income: Quintile 5 (highest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="274"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="73"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school educated, Quintile 1 (lowest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="551"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school educated, Quintile 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="106"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="33"/>
                    <measurement group_id="O5" value="71"/>
                    <measurement group_id="O6" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school educated, Quintile 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="212"/>
                    <measurement group_id="O3" value="215"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="63"/>
                    <measurement group_id="O6" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school educated, Quintile 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="319"/>
                    <measurement group_id="O3" value="132"/>
                    <measurement group_id="O4" value="40"/>
                    <measurement group_id="O5" value="52"/>
                    <measurement group_id="O6" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school educated, Quintile 5 (highest)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="274"/>
                    <measurement group_id="O3" value="157"/>
                    <measurement group_id="O4" value="73"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Residence: Urban</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="947"/>
                    <measurement group_id="O2" value="858"/>
                    <measurement group_id="O3" value="762"/>
                    <measurement group_id="O4" value="218"/>
                    <measurement group_id="O5" value="258"/>
                    <measurement group_id="O6" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Residence: Rural</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary SEER Diagnosis: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="98"/>
                    <measurement group_id="O5" value="132"/>
                    <measurement group_id="O6" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary SEER Diagnosis: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="966"/>
                    <measurement group_id="O2" value="885"/>
                    <measurement group_id="O3" value="828"/>
                    <measurement group_id="O4" value="124"/>
                    <measurement group_id="O5" value="142"/>
                    <measurement group_id="O6" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage of secondary SEER Diagnosis: DCIS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="290"/>
                    <measurement group_id="O2" value="274"/>
                    <measurement group_id="O3" value="282"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="47"/>
                    <measurement group_id="O6" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage of secondary SEER Diagnosis: Stage I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425"/>
                    <measurement group_id="O2" value="395"/>
                    <measurement group_id="O3" value="364"/>
                    <measurement group_id="O4" value="60"/>
                    <measurement group_id="O5" value="63"/>
                    <measurement group_id="O6" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage of secondary SEER Diagnosis: Stage II-III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="177"/>
                    <measurement group_id="O3" value="132"/>
                    <measurement group_id="O4" value="24"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage of secondary SEER Diagnosis: Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ER status of secondary SEER diagnosis: Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="609"/>
                    <measurement group_id="O2" value="566"/>
                    <measurement group_id="O3" value="497"/>
                    <measurement group_id="O4" value="75"/>
                    <measurement group_id="O5" value="85"/>
                    <measurement group_id="O6" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ER status of secondary SEER diagnosis: Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="124"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ER status of secondary SEER diagnosis: Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251"/>
                    <measurement group_id="O2" value="195"/>
                    <measurement group_id="O3" value="232"/>
                    <measurement group_id="O4" value="38"/>
                    <measurement group_id="O5" value="44"/>
                    <measurement group_id="O6" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laterality of secondary SEER diagnosis:Ipsilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580"/>
                    <measurement group_id="O2" value="522"/>
                    <measurement group_id="O3" value="513"/>
                    <measurement group_id="O4" value="82"/>
                    <measurement group_id="O5" value="88"/>
                    <measurement group_id="O6" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laterality of secondary SEER diag.: Contralateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386"/>
                    <measurement group_id="O2" value="363"/>
                    <measurement group_id="O3" value="315"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year of secondary diag.: 1990-1995</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year of secondary diag.: 1996-2000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="190"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="52"/>
                    <measurement group_id="O6" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year of secondary diag.: 2001-2005</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="319"/>
                    <measurement group_id="O2" value="239"/>
                    <measurement group_id="O3" value="215"/>
                    <measurement group_id="O4" value="82"/>
                    <measurement group_id="O5" value="88"/>
                    <measurement group_id="O6" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year of secondary diag.: 2006-2011</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="464"/>
                    <measurement group_id="O2" value="513"/>
                    <measurement group_id="O3" value="364"/>
                    <measurement group_id="O4" value="89"/>
                    <measurement group_id="O5" value="121"/>
                    <measurement group_id="O6" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Charlson comorbidity score: 0-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="202"/>
                    <measurement group_id="O5" value="252"/>
                    <measurement group_id="O6" value="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Charlson comorbidity score: 2+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distance to nearest radiation facility: &lt;10 mi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="206"/>
                    <measurement group_id="O5" value="225"/>
                    <measurement group_id="O6" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distance to nearest radiation facility: 10+ mi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="49"/>
                    <measurement group_id="O6" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chemotherapy for secondary breast event: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="209"/>
                    <measurement group_id="O5" value="260"/>
                    <measurement group_id="O6" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chemotherapy for secondary breast event: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>A two-sided p value of less than 0.05 was considered to indicate statistical significance.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>This group is the reference group.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>A two-sided p value of less than 0.05 was considered to indicate statistical significance.</p_value_desc>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>2.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were not collected for this study.</time_frame>
      <desc>This was a retrospective review of data from the SEER and SEER-Medicare registries. There were no adverse events to report because this was not a clinical trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>SEER</title>
          <description>Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer</description>
        </group>
        <group group_id="E2">
          <title>SEER-Medicare</title>
          <description>Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer</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>
    <limitations_and_caveats>No data set can capture all of the complexity surrounding surgical decision making at the time of a second diagnosis. We did not have information about patient preferences or the clinical characteristics about second breast event.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rinaa Punglia, MD</name_or_title>
      <organization>Dana-Farber Cancer Institute</organization>
      <phone>617-582-8759</phone>
      <email>rinaa_punglia@dfci.harvard.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/NCT02248662
org study id: 12-420
secondary id: CE-12-11-4173
nct id: NCT02248662
lead sponsor: 
collaborator: 
has dmc: Yes
Large regional variation exists in the use of radiotherapy after breast-conserving surgery
      (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial
      radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast
      event, many undergo mastectomy instead.
Patients and their physicians are often confronted with a decision between more intensive
      versus less intensive treatment for a particular diagnosis. Quality decision-making between
      these options requires careful balancing of the risks and side-effects, as well as weighing
      the expected outcomes and their associated value as assessed by the patient.

      Although the incidence of DCIS has risen dramatically (1), there exists considerable debate
      about optimal treatment. In general, people with DCIS have high rates of recurrence-free
      survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or
      radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but
      have not been shown to improve survival.(6) In addition, radiation usually necessitates
      mastectomy should a new cancer or DCIS develop in the same breast at any point during the
      patient's lifetime. Patients also have a small chance of experiencing long-term toxicity.
      Previous radiation can also complicate reconstructive options following mastectomy. The
      tradeoff between risk of second breast diagnosis and side-effects and potential consequences
      of radiation therapy underscores the need for patient preference-driven decision making.

      Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if
      they have a second breast event in the same breast. One study suggests that some women choose
      not to have radiation after DCIS because they want to preserve a breast-preservation option
      should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS
      at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a
      woman receives repeat breast-conserving surgery for a new diagnosis may not only be a
      function of the stage of diagnosis, but may be also determined by the regional treatment
      patterns used for management of DCIS. We sought to study whether regional intensity of
      radiation use for DCIS treatment increases the likelihood of mastectomy at time of second
      breast event, among women who have not received radiation therapy at initial DCIS diagnosis.
      (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma
      In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July
      21, 2016.)
observational model: Other
time perspective: Retrospective
measure: Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS
time frame: 20 Years
description: The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster.
arm group label: Surveillance, Epidemiology, and End Results (SEER) Database
description: Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.
arm group label: Surveillance, Epidemiology, and End Results (SEER)-Medicare
description: Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rinaa S. Punglia, MD, MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Sumner WE 3rd, Koniaris LG, Snell SE, Spector S, Powell J, Avisar E, Moffat F, Livingstone AS, Franceschi D. Results of 23,810 cases of ductal carcinoma-in-situ. Ann Surg Oncol. 2007 May;14(5):1638-43. doi: 10.1245/s10434-006-9316-1. Epub 2007 Jan 24.
PMID: 17245612
citation: Kim SY, Han BK, Kim EK, Choi WJ, Choi Y, Kim HH, Moon WK. Breast Cancer Detected at Screening US: Survival Rates and Clinical-Pathologic and Imaging Factors Associated with Recurrence. Radiology. 2017 Aug;284(2):354-364. doi: 10.1148/radiol.2017162348. Epub 2017 Apr 6.
PMID: 28387638
citation: EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.
PMID: 16801628
citation: Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2.
PMID: 11498833
citation: Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.
PMID: 16864166
citation: Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7.
PMID: 12867108
citation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039.
PMID: 20956824
citation: Kaplan CP, Napoles AM, Hwang ES, Bloom J, Stewart S, Nickleach D, Karliner L. Selection of treatment among Latina and non-Latina white women with ductal carcinoma in situ. J Womens Health (Larchmt). 2011 Feb;20(2):215-23. doi: 10.1089/jwh.2010.1986. Epub 2010 Dec 3.
PMID: 21128819
citation: Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441.
PMID: 9469327
citation: Fong J, Kurniawan ED, Rose AK, Mou A, Collins JP, Miller JA, Mann GB. Outcomes of screening-detected ductal carcinoma in situ treated with wide excision alone. Ann Surg Oncol. 2011 Dec;18(13):3778-84. doi: 10.1245/s10434-011-1748-6. Epub 2011 Jun 1.
PMID: 21630124
citation: Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.
PMID: 16461781
citation: Pickle LW, MungioleM, Jones GK, White AA. Atlas of United States Mortality. Hyattsville, MD: Centers for Disease Control and Prevention; December 1996. http://www.cdc.gov/nchs/data/misc/atlasmet.pdf. Accessed September 1, 2015.
citation: Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicare reform. Health Aff (Millwood). 2002 Jul-Dec;Suppl Web Exclusives:W96-114. doi: 10.1377/hlthaff.w2.96.
PMID: 12703563
citation: Jagsi R, Abrahamse P, Hawley ST, Graff JJ, Hamilton AS, Katz SJ. Underascertainment of radiotherapy receipt in Surveillance, Epidemiology, and End Results registry data. Cancer. 2012 Jan 15;118(2):333-41. doi: 10.1002/cncr.26295. Epub 2011 Jun 29.
PMID: 21717446
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Rinaa Punglia, MD MPH
investigator title: Principal Investigator
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No data set can capture all of the complexity surrounding surgical decision making at the time of a second diagnosis. We did not have information about patient preferences or the clinical characteristics about second breast event.
point of contact: 