<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/NCT02263014</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0752</org_study_id>
    <nct_id>NCT02263014</nct_id>
  </id_info>
  <brief_title>Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)</brief_title>
  <official_title>Treatment Decisions and Breast Cancer: Psychosocial Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to learn more about how different treatment decisions may&#xD;
      influence the quality of life in women with breast cancer. Researchers want to use what is&#xD;
      learned from this study to help future patients with breast cancer to be more informed when&#xD;
      making treatment decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With your verbal permission, you may have been asked to complete a questionnaire about your&#xD;
      surgical treatment preferences for breast cancer as part of initial screening for this study.&#xD;
      This takes about 5 minutes to complete.&#xD;
&#xD;
      If you agree to participate in this study, during the same visit you will complete a&#xD;
      questionnaire about your background, such as your education level, marital status, and family&#xD;
      history of cancer. This should take about 3 minutes to complete.&#xD;
&#xD;
      You will also be asked to complete a questionnaire about your surgery decisions and your&#xD;
      feelings about those decisions at the following times: around the time you enroll in study&#xD;
      before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This&#xD;
      questionnaire should take about 30-40 minutes to complete each time. You may complete this&#xD;
      questionnaire at the clinic or you may complete it at home. If you chose to complete the&#xD;
      questionnaire at home, you will be given a postage-paid envelope to mail it back to the study&#xD;
      staff.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      After you complete all of the questionnaires, your participation in this study will be over.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at&#xD;
      MD Anderson and up to 100 will take part at Kelsey-Seybold.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2014</start_date>
  <completion_date type="Actual">February 24, 2020</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score</measure>
    <time_frame>Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.</time_frame>
    <description>Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision</measure>
    <time_frame>One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.</time_frame>
    <description>The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is &quot;strongly disagree&quot; and 5 is &quot;strongly agree&quot; and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">345</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Contralateral Prophylactic Mastectomy (CPM) Group</arm_group_label>
    <description>Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Contralateral Prophylactic Mastectomy (CPM) Group</arm_group_label>
    <description>Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.</description>
    <arm_group_label>Contralateral Prophylactic Mastectomy (CPM) Group</arm_group_label>
    <arm_group_label>No Contralateral Prophylactic Mastectomy (CPM) Group</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey&#xD;
        Seybold Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral&#xD;
             invasive breast cancer&#xD;
&#xD;
          2. Age 18 or older&#xD;
&#xD;
          3. Able to speak, read, and write English.&#xD;
&#xD;
          4. Spouse/Partner: Married or living with patient for a year or more&#xD;
&#xD;
          5. Spouse/Partner: Age 18 or older&#xD;
&#xD;
          6. Spouse/Partner: Able to speak, read, and write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous breast cancer&#xD;
&#xD;
          2. Prior history of prophylactic mastectomy&#xD;
&#xD;
          3. Known to have a germline gene mutation that predisposes them to an increased risk of&#xD;
             breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for&#xD;
             contralateral breast cancer on the basis of a strong family history of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abenaa M. Brewster, MD, MHS, BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kelsey-Seybold</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>March 14, 2017</results_first_submitted>
  <results_first_submitted_qc>October 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 5, 2020</results_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Contralateral Prophylactic Mastectomy</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Psychosocial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 30, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT02263014/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: February 24, 2014 to December 31, 2015. All recruitment done at The University of Texas MD Anderson and Kelsey Seybold Clinics.</recruitment_details>
      <pre_assignment_details>Of the 345 women enrolled some were excluded from the study, 37 were determined to be ineligible for participation (reasons included BRCA1/2 carrier, no breast surgery performed, no breast surgery at institutions, metastatic disease at diagnosis) and another 56 women did not complete the required baseline (pre-surgery) assessment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CPM Group</title>
          <description>Contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.</description>
        </group>
        <group group_id="P2">
          <title>No CPM Group</title>
          <description>No CPM performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="208"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="208"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CPM Group</title>
          <description>CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery.</description>
        </group>
        <group group_id="B2">
          <title>No CPM Group</title>
          <description>No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.</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="44"/>
            <count group_id="B2" value="208"/>
            <count group_id="B3" value="252"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" lower_limit="30" upper_limit="75"/>
                    <measurement group_id="B2" value="57.4" lower_limit="25" upper_limit="82"/>
                    <measurement group_id="B3" value="56" lower_limit="25" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="208"/>
                    <measurement group_id="B3" value="252"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="174"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="208"/>
                    <measurement group_id="B3" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage, Breast Cancer</title>
          <description>American Joint Committee on Cancer (AJCC) Breast cancer staging: Anatomic stage 0, I, II, III or IV. AJCC staging system provides strategy for grouping participants by prognosis, based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined , and an overall stage of 0, I, II, III, IV is assigned from least advanced to more advanced.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="18.4"/>
                    <measurement group_id="B3" value="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.6"/>
                    <measurement group_id="B2" value="38.2"/>
                    <measurement group_id="B3" value="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.3"/>
                    <measurement group_id="B2" value="38.6"/>
                    <measurement group_id="B3" value="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.1"/>
                    <measurement group_id="B2" value="6.8"/>
                    <measurement group_id="B3" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Surgery</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Bilateral mastectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unilateral mastectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="32.7"/>
                    <measurement group_id="B3" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breast conserving surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="67.3"/>
                    <measurement group_id="B3" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score</title>
        <description>Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.</description>
        <time_frame>Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.</time_frame>
        <population>Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CPM Group</title>
            <description>CPM along with scheduled mastectomy. Questionnaires completed at baseline (pre-surgery) and at 1, 6, and 12 months post-surgery.</description>
          </group>
          <group group_id="O2">
            <title>No CPM Group</title>
            <description>No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at baseline (pre-surgery), and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score</title>
          <description>Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.</description>
          <population>Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="207"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.98" spread="16.77"/>
                    <measurement group_id="O2" value="24.62" spread="16.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Month Post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.84" spread="14.58"/>
                    <measurement group_id="O2" value="19.84" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="196"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.43" spread="14.69"/>
                    <measurement group_id="O2" value="18.56" spread="16.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months Post-surgery</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="17.26"/>
                    <measurement group_id="O2" value="17.01" spread="14.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision</title>
        <description>The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is &quot;strongly disagree&quot; and 5 is &quot;strongly agree&quot; and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.</description>
        <time_frame>One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.</time_frame>
        <population>Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CPM Group</title>
            <description>Contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.</description>
          </group>
          <group group_id="O2">
            <title>No CPM Group</title>
            <description>No CPM performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision</title>
          <description>The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is &quot;strongly disagree&quot; and 5 is &quot;strongly agree&quot; and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.</description>
          <population>Two participants of the CPM Group (N=44) who had CPM after the date of their primary surgery were excluded from the longitudinal study analysis. *The overall number of patients analyzed may differ from the total number analyzed at each time point since not all surveys were returned at each time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Month assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="1.08"/>
                    <measurement group_id="O2" value="4.27" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.18" spread="1.06"/>
                    <measurement group_id="O2" value="4.33" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.35" spread="0.86"/>
                    <measurement group_id="O2" value="4.34" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected up to 12 months following surgery for breast cancer.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CPM Group</title>
          <description>CPM along with scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after surgery.</description>
        </group>
        <group group_id="E2">
          <title>No CPM Group</title>
          <description>No CPM performed during scheduled mastectomy. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery.</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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
              </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="44"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
              </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 an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Abenaa Brewster, Professor, Clinical Cancer Prevention</name_or_title>
      <organization>The University of Texas (UT) MD Anderson Cancer Center</organization>
      <phone>713-792-7734</phone>
      <email>abrewster@mdanderson.org</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/NCT02263014
org study id: 2013-0752
nct id: NCT02263014
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this research study is to learn more about how different treatment decisions may
      influence the quality of life in women with breast cancer. Researchers want to use what is
      learned from this study to help future patients with breast cancer to be more informed when
      making treatment decisions.
With your verbal permission, you may have been asked to complete a questionnaire about your
      surgical treatment preferences for breast cancer as part of initial screening for this study.
      This takes about 5 minutes to complete.

      If you agree to participate in this study, during the same visit you will complete a
      questionnaire about your background, such as your education level, marital status, and family
      history of cancer. This should take about 3 minutes to complete.

      You will also be asked to complete a questionnaire about your surgery decisions and your
      feelings about those decisions at the following times: around the time you enroll in study
      before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This
      questionnaire should take about 30-40 minutes to complete each time. You may complete this
      questionnaire at the clinic or you may complete it at home. If you chose to complete the
      questionnaire at home, you will be given a postage-paid envelope to mail it back to the study
      staff.

      Length of Study:

      After you complete all of the questionnaires, your participation in this study will be over.

      This is an investigational study.

      A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at
      MD Anderson and up to 100 will take part at Kelsey-Seybold.
observational model: Cohort
time perspective: Prospective
measure: Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
time frame: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
description: Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.
measure: Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
time frame: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
description: The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.
arm group label: Contralateral Prophylactic Mastectomy (CPM) Group
description: Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.
arm group label: No Contralateral Prophylactic Mastectomy (CPM) Group
description: Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.
intervention type: Behavioral
intervention name: Questionnaires
description: Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.
arm group label: Contralateral Prophylactic Mastectomy (CPM) Group
arm group label: No Contralateral Prophylactic Mastectomy (CPM) Group
other name: Surveys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Abenaa M. Brewster, MD, MHS, BS
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Breast Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 