<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/NCT02976103</url>
  </required_header>
  <id_info>
    <org_study_id>16-403</org_study_id>
    <nct_id>NCT02976103</nct_id>
  </id_info>
  <brief_title>Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket</brief_title>
  <official_title>Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket: Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daisy Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is studying a garment called the Jacki® recovery jacket that can be worn&#xD;
      after surgery as a possible way to manage pain from surgical drains.&#xD;
&#xD;
      The study intervention involved in this study is:&#xD;
&#xD;
      -&quot;Jacki&quot; recovery jacket&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this research study, the investigators are studying the Jacki, a garment that can be worn&#xD;
      post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a&#xD;
      cancer survivor who leads A Little Easier Recovery®, a non-profit organization in&#xD;
      Massachusetts, and may help participants manage the pain of post-surgical drains to increase&#xD;
      comfort and ease of daily living. The jacket has not previously been tested in a research&#xD;
      study. The investigators are hoping to learn whether the jacket is effective in reducing pain&#xD;
      and discomfort from the time participants leave the hospital until they return to have their&#xD;
      drains removed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Actual">January 11, 2018</completion_date>
  <primary_completion_date type="Actual">January 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Distress Scale - Pain Frequency</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>1 item (score range 1-5); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Distress Scale - Pain Intensity</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>1 item (score range 1-5); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pain Intensity Scale (Short Form 3a)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>3 items (T score 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pain Interference Scale - Short Form 8a</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>8 items (T score 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Global QOL Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>2 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Physical Functioning Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>5 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Role Functioning Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>2 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Emotional Functioning Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>4 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Cognitive Functioning Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>2 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30: Social Functioning Scale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>2 items; score range 0-100 (higher score = better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Body Image Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>4 items (score 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Sexual Functioning Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>2 items (range 0-100); higher score = better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Sexual Enjoyment Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>1 item (range 0-100); higher score = better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Future Perspective Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>1 item (range 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>7 items (range 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Breast Symptoms Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>4 items (range 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Arm Symptoms Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>3 items (range 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23: Upset by Hair Loss Subscale</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>1 item (range 0-100); higher score = worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)</measure>
    <time_frame>1 week</time_frame>
    <description>Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Management At Home: Use of Pain Medication (Daily Diary)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Management At Home: Use of Mastectomy Bra (Daily Diary)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)</measure>
    <time_frame>1-2 weeks</time_frame>
    <description>Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Mastectomy</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>-Standard Care pain medicine/management will be given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JACKI® RECOVERY JACKET + Standard Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jacki Recovery jacket</intervention_name>
    <description>An outer jacket that holds surgical drains and allows access for blood draws</description>
    <arm_group_label>JACKI® RECOVERY JACKET + Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care Pain medicine/management</intervention_name>
    <description>Standard care pain medicine and management in hospitals where the study enrolls</description>
    <arm_group_label>JACKI® RECOVERY JACKET + Standard Care</arm_group_label>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are ≥ 18 years old.&#xD;
&#xD;
          -  Patients who speak and understand English.&#xD;
&#xD;
          -  Patients who have had mastectomy with reconstructive surgery in one or both breasts.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-morbid delirium&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Mental illness, or neurocognitive deficit prohibiting informed consent and/or ability&#xD;
             to complete study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Berry, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Faulkner Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Berry DL, Blonquist TM, Halpenny B, Hong F, Morrison-Ma SC, McCullough MC, Carelli K, Dominici LS, King TA. The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study. Breast Cancer Res Treat. 2020 Jan;179(2):377-385. doi: 10.1007/s10549-019-05465-9. Epub 2019 Oct 14.</citation>
    <PMID>31612292</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>February 19, 2020</results_first_submitted>
  <results_first_submitted_qc>February 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 12, 2020</results_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Donna Berry, PhD, RN, FAAN, AOCN</investigator_full_name>
    <investigator_title>Donna Berry, PhD, RN</investigator_title>
  </responsible_party>
  <keyword>recovery</keyword>
  <keyword>pain</keyword>
  <keyword>surgical drains</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>November 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT02976103/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment dates: 03/09/2017-12/21/2017</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
        </group>
        <group group_id="P2">
          <title>JACKI® RECOVERY JACKET + Standard Care</title>
          <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54">54 participants answered final (T3) questionnaire</participants>
                <participants group_id="P2" count="64">64 participants answered final (T3 questionnaire)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
        </group>
        <group group_id="B2">
          <title>JACKI® RECOVERY JACKET + Standard Care</title>
          <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</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="67"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="139"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" lower_limit="23" upper_limit="75"/>
                    <measurement group_id="B2" value="47" lower_limit="25" upper_limit="66"/>
                    <measurement group_id="B3" value="48" lower_limit="23" upper_limit="75"/>
                  </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="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="139"/>
                  </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="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (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="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Intensity Numeric (0-10) Scale (PINS)</title>
          <description>1 item (score 0-10); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.7" spread="2.2"/>
                    <measurement group_id="B2" value="4.7" spread="2.0"/>
                    <measurement group_id="B3" value="4.7" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Symptom Distress Scale - Pain Frequency</title>
          <population>1 participant did not provide a response</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.9" spread="1.0"/>
                    <measurement group_id="B2" value="3.8" spread="1.1"/>
                    <measurement group_id="B3" value="3.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Symptom Distress Scale - Pain Intensity</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.0" spread="1.0"/>
                    <measurement group_id="B2" value="2.8" spread="0.8"/>
                    <measurement group_id="B3" value="3.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Pain Intensity Short Form 3a</title>
          <description>3 items (T score 0-100); higher score = worse outcome</description>
          <population>2 participants did not complete the required items to calculate a total score</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="65"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.4" spread="6.7"/>
                    <measurement group_id="B2" value="53.7" spread="5.4"/>
                    <measurement group_id="B3" value="54.0" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)</title>
        <description>Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Standard Care arm (n=54): 52 of 54 participants who answered T3 with a PINS score, plus 2 participants who answered for the same day in their T2 diary Jacki+Standard Care arm (n=68): 64 of 64 participants who answered T3 with a PINS score, plus 4 participants who answered for the same day in their T2 diary</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)</title>
          <description>Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)</description>
          <population>Standard Care arm (n=54): 52 of 54 participants who answered T3 with a PINS score, plus 2 participants who answered for the same day in their T2 diary Jacki+Standard Care arm (n=68): 64 of 64 participants who answered T3 with a PINS score, plus 4 participants who answered for the same day in their T2 diary</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.7"/>
                    <measurement group_id="O2" value="2.1" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Distress Scale - Pain Frequency</title>
        <description>1 item (score range 1-5); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>13 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Distress Scale - Pain Frequency</title>
          <description>1 item (score range 1-5); higher score = worse outcome</description>
          <population>13 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Distress Scale - Pain Intensity</title>
        <description>1 item (score range 1-5); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>14 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Distress Scale - Pain Intensity</title>
          <description>1 item (score range 1-5); higher score = worse outcome</description>
          <population>14 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.9"/>
                    <measurement group_id="O2" value="2.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Pain Intensity Scale (Short Form 3a)</title>
        <description>3 items (T score 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>13 participants in the Standard Care arm and 9 in the Jacki Jacket arm (Total of 21) did not provide complete data to calculate this scale</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Pain Intensity Scale (Short Form 3a)</title>
          <description>3 items (T score 0-100); higher score = worse outcome</description>
          <population>13 participants in the Standard Care arm and 9 in the Jacki Jacket arm (Total of 21) did not provide complete data to calculate this scale</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.8" spread="7.0"/>
                    <measurement group_id="O2" value="46.1" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Pain Interference Scale - Short Form 8a</title>
        <description>8 items (T score 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>13 participants in the Standard Care arm and 10 in the Jacki Jacket arm (total of 23) did not complete answer the T3 questionnaire or did not answer all items required to calculate a score</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Pain Interference Scale - Short Form 8a</title>
          <description>8 items (T score 0-100); higher score = worse outcome</description>
          <population>13 participants in the Standard Care arm and 10 in the Jacki Jacket arm (total of 23) did not complete answer the T3 questionnaire or did not answer all items required to calculate a score</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.9" spread="8.4"/>
                    <measurement group_id="O2" value="59.1" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Global QOL Scale</title>
        <description>2 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Global QOL Scale</title>
          <description>2 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" spread="17.2"/>
                    <measurement group_id="O2" value="64.1" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Physical Functioning Scale</title>
        <description>5 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Physical Functioning Scale</title>
          <description>5 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.3" spread="23.9"/>
                    <measurement group_id="O2" value="71.7" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Role Functioning Scale</title>
        <description>2 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Role Functioning Scale</title>
          <description>2 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="27.2"/>
                    <measurement group_id="O2" value="40.3" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Emotional Functioning Scale</title>
        <description>4 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Emotional Functioning Scale</title>
          <description>4 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="20.1"/>
                    <measurement group_id="O2" value="73.3" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Cognitive Functioning Scale</title>
        <description>2 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Cognitive Functioning Scale</title>
          <description>2 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.0" spread="22.9"/>
                    <measurement group_id="O2" value="81.0" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-C30: Social Functioning Scale</title>
        <description>2 items; score range 0-100 (higher score = better outcome)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>T3 respondents</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-C30: Social Functioning Scale</title>
          <description>2 items; score range 0-100 (higher score = better outcome)</description>
          <population>T3 respondents</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.0" spread="28.7"/>
                    <measurement group_id="O2" value="56.5" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Body Image Subscale</title>
        <description>4 items (score 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Body Image Subscale</title>
          <description>4 items (score 0-100); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="29.8"/>
                    <measurement group_id="O2" value="64.8" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Sexual Functioning Subscale</title>
        <description>2 items (range 0-100); higher score = better outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Sexual Functioning Subscale</title>
          <description>2 items (range 0-100); higher score = better outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" spread="18.3"/>
                    <measurement group_id="O2" value="15.8" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Sexual Enjoyment Subscale</title>
        <description>1 item (range 0-100); higher score = better outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Sexual Enjoyment Subscale</title>
          <description>1 item (range 0-100); higher score = better outcome</description>
          <population>The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9" spread="35.2"/>
                    <measurement group_id="O2" value="57.6" spread="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Future Perspective Subscale</title>
        <description>1 item (range 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Future Perspective Subscale</title>
          <description>1 item (range 0-100); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.4" spread="30.2"/>
                    <measurement group_id="O2" value="53.1" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale</title>
        <description>7 items (range 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale</title>
          <description>7 items (range 0-100); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" spread="12.6"/>
                    <measurement group_id="O2" value="15.4" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Breast Symptoms Subscale</title>
        <description>4 items (range 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Breast Symptoms Subscale</title>
          <description>4 items (range 0-100); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="21.9"/>
                    <measurement group_id="O2" value="31.4" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Arm Symptoms Subscale</title>
        <description>3 items (range 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Arm Symptoms Subscale</title>
          <description>3 items (range 0-100); higher score = worse outcome</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="20.2"/>
                    <measurement group_id="O2" value="30.9" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EORTC QLQ-BR23: Upset by Hair Loss Subscale</title>
        <description>1 item (range 0-100); higher score = worse outcome</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>EORTC QLQ-BR23: Upset by Hair Loss Subscale</title>
          <description>1 item (range 0-100); higher score = worse outcome</description>
          <population>Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" spread="38.8"/>
                    <measurement group_id="O2" value="24.2" spread="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)</title>
        <description>Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)</description>
        <time_frame>1 week</time_frame>
        <population>16 in Jacki arm and 21 in Standard Care arm did not return T2 diary; 2 in Standard Care arm returned diary with missing data, for a total of 23 missing this measure in Standard Care arm</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)</title>
          <description>Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)</description>
          <population>16 in Jacki arm and 21 in Standard Care arm did not return T2 diary; 2 in Standard Care arm returned diary with missing data, for a total of 23 missing this measure in Standard Care arm</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="4.4" lower_limit="2.9" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Management At Home: Use of Pain Medication (Daily Diary)</title>
        <description>Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Management At Home: Use of Pain Medication (Daily Diary)</title>
          <description>Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)</description>
          <population>Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose</population>
          <units>morphine equivalent dose units</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="2.3" upper_limit="16.1"/>
                    <measurement group_id="O2" value="10.7" lower_limit="2.2" upper_limit="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Management At Home: Use of Mastectomy Bra (Daily Diary)</title>
        <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Participants who returned a T2 diary with sufficient data on wearing a mastectomy bra to calculate a proportion for the first 7 days post-discharge</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Management At Home: Use of Mastectomy Bra (Daily Diary)</title>
          <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)</description>
          <population>Participants who returned a T2 diary with sufficient data on wearing a mastectomy bra to calculate a proportion for the first 7 days post-discharge</population>
          <units>Proportion of days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)</title>
        <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Participants who returned a T2 diary with sufficient data on wearing a mastectomy camisole to calculate a proportion for the first 7 days post-discharge</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
          <group group_id="O2">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)</title>
          <description>Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)</description>
          <population>Participants who returned a T2 diary with sufficient data on wearing a mastectomy camisole to calculate a proportion for the first 7 days post-discharge</population>
          <units>Proportion of days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.1" lower_limit="0.0" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)</title>
        <description>Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse</description>
        <time_frame>1-2 weeks</time_frame>
        <population>Summary measure for participants in the Jacki Recovery Jacket + Standard Care arm only. A proportion score was calculated if the measure was reported for at least 5 of the first 7 days post-discharge. Of 73 participants assigned to this arm, 53 returned a T2 diary, and 49 had sufficient data to calculate a proportion score.</population>
        <group_list>
          <group group_id="O1">
            <title>JACKI® RECOVERY JACKET + Standard Care</title>
            <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)</title>
          <description>Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse</description>
          <population>Summary measure for participants in the Jacki Recovery Jacket + Standard Care arm only. A proportion score was calculated if the measure was reported for at least 5 of the first 7 days post-discharge. Of 73 participants assigned to this arm, 53 returned a T2 diary, and 49 had sufficient data to calculate a proportion score.</population>
          <units>Proportion of days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.6" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected only when the participant was on study (usually 1-6 weeks).</time_frame>
      <desc>Per protocol, adverse events that could reasonably be expected to relate to the NSR device (jacket) included:&#xD;
Dislodging post-surgical drains, possibly resulting in infection&#xD;
Becoming over warm or irritating skin&#xD;
Data were collected by chart review and patient report either verbally to the study coordinator or on the study diary.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>-Standard Care pain medicine/management will be given&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</description>
        </group>
        <group group_id="E2">
          <title>JACKI® RECOVERY JACKET + Standard Care</title>
          <description>Patient will be encouraged to use the Jacki Recovery Jacket at home&#xD;
Patient will be taught how to tuck the drainage tubes in the jacket pocket&#xD;
Patient will be taught how to un-tuck the drainage tubes from jacket pocket&#xD;
Standard care pain medicine/management will be given&#xD;
Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws&#xD;
Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls</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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Donna Berry, PhD, RN</name_or_title>
      <organization>Dana-Farber Cancer Institute</organization>
      <phone>617-632-1909</phone>
      <email>donna_berry@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/NCT02976103
org study id: 16-403
nct id: NCT02976103
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This research study is studying a garment called the Jacki® recovery jacket that can be worn
      after surgery as a possible way to manage pain from surgical drains.

      The study intervention involved in this study is:

      -"Jacki" recovery jacket
In this research study, the investigators are studying the Jacki, a garment that can be worn
      post-mastectomy with pockets that hold post-surgical drains. The Jacki was invented by a
      cancer survivor who leads A Little Easier Recovery®, a non-profit organization in
      Massachusetts, and may help participants manage the pain of post-surgical drains to increase
      comfort and ease of daily living. The jacket has not previously been tested in a research
      study. The investigators are hoping to learn whether the jacket is effective in reducing pain
      and discomfort from the time participants leave the hospital until they return to have their
      drains removed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)
time frame: 1-2 weeks
description: Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)
measure: Symptom Distress Scale - Pain Frequency
time frame: 1-2 weeks
description: 1 item (score range 1-5); higher score = worse outcome
measure: Symptom Distress Scale - Pain Intensity
time frame: 1-2 weeks
description: 1 item (score range 1-5); higher score = worse outcome
measure: PROMIS Pain Intensity Scale (Short Form 3a)
time frame: 1-2 weeks
description: 3 items (T score 0-100); higher score = worse outcome
measure: PROMIS Pain Interference Scale - Short Form 8a
time frame: 1-2 weeks
description: 8 items (T score 0-100); higher score = worse outcome
measure: EORTC QLQ-C30: Global QOL Scale
time frame: 1-2 weeks
description: 2 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-C30: Physical Functioning Scale
time frame: 1-2 weeks
description: 5 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-C30: Role Functioning Scale
time frame: 1-2 weeks
description: 2 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-C30: Emotional Functioning Scale
time frame: 1-2 weeks
description: 4 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-C30: Cognitive Functioning Scale
time frame: 1-2 weeks
description: 2 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-C30: Social Functioning Scale
time frame: 1-2 weeks
description: 2 items; score range 0-100 (higher score = better outcome)
measure: EORTC QLQ-BR23: Body Image Subscale
time frame: 1-2 weeks
description: 4 items (score 0-100); higher score = worse outcome
measure: EORTC QLQ-BR23: Sexual Functioning Subscale
time frame: 1-2 weeks
description: 2 items (range 0-100); higher score = better outcome
measure: EORTC QLQ-BR23: Sexual Enjoyment Subscale
time frame: 1-2 weeks
description: 1 item (range 0-100); higher score = better outcome
measure: EORTC QLQ-BR23: Future Perspective Subscale
time frame: 1-2 weeks
description: 1 item (range 0-100); higher score = worse outcome
measure: EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale
time frame: 1-2 weeks
description: 7 items (range 0-100); higher score = worse outcome
measure: EORTC QLQ-BR23: Breast Symptoms Subscale
time frame: 1-2 weeks
description: 4 items (range 0-100); higher score = worse outcome
measure: EORTC QLQ-BR23: Arm Symptoms Subscale
time frame: 1-2 weeks
description: 3 items (range 0-100); higher score = worse outcome
measure: EORTC QLQ-BR23: Upset by Hair Loss Subscale
time frame: 1-2 weeks
description: 1 item (range 0-100); higher score = worse outcome
measure: Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)
time frame: 1 week
description: Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)
measure: Pain Management At Home: Use of Pain Medication (Daily Diary)
time frame: 1-2 weeks
description: Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)
measure: Pain Management At Home: Use of Mastectomy Bra (Daily Diary)
time frame: 1-2 weeks
description: Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)
measure: Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)
time frame: 1-2 weeks
description: Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)
measure: Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)
time frame: 1-2 weeks
description: Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse
arm group label: Standard Care
arm group type: Other
description: -Standard Care pain medicine/management will be given
arm group label: JACKI® RECOVERY JACKET + Standard Care
arm group type: Experimental
description: Patient will be encouraged to use the Jacki Recovery Jacket at home
Patient will be taught how to tuck the drainage tubes in the jacket pocket
Patient will be taught how to un-tuck the drainage tubes from jacket pocket
Standard care pain medicine/management will be given
intervention type: Device
intervention name: Jacki Recovery jacket
description: An outer jacket that holds surgical drains and allows access for blood draws
arm group label: JACKI® RECOVERY JACKET + Standard Care
intervention type: Other
intervention name: Standard Care Pain medicine/management
description: Standard care pain medicine and management in hospitals where the study enrolls
arm group label: JACKI® RECOVERY JACKET + Standard Care
arm group label: Standard Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donna Berry, PhD, RN
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
country: United States
citation: Berry DL, Blonquist TM, Halpenny B, Hong F, Morrison-Ma SC, McCullough MC, Carelli K, Dominici LS, King TA. The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study. Breast Cancer Res Treat. 2020 Jan;179(2):377-385. doi: 10.1007/s10549-019-05465-9. Epub 2019 Oct 14.
PMID: 31612292
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Donna Berry, PhD, RN, FAAN, AOCN
investigator title: Donna Berry, PhD, RN
mesh term: Analgesics
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 