<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/NCT04477538</url>
  </required_header>
  <id_info>
    <org_study_id>202006199</org_study_id>
    <nct_id>NCT04477538</nct_id>
  </id_info>
  <brief_title>Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction</brief_title>
  <official_title>The Impact of Operative Approach on Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this proposal is to broadly assess patient physical functioning following&#xD;
      breast reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the physical well-being Q-score derived from the BREAST-Q between the two groups</measure>
    <time_frame>Completion of study (estimated to be 30 months)</time_frame>
    <description>The physical well-being module is one of the domains of the BREAST-Q that can be administered in isolation. Patients answer specific questions with answers that range from 1-4 to 1-5. Upon completion of this component of the survey, a physical well-being-specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100. This same approach is used for all other domains of the BREAST-Q. Pre- versus postoperative Q-scores for physical well-being can be directly compared to study the impact of surgery on physical well-being. Similarly, the physical-well-being domain can be readministered to provide a longitudinal assessment of physical function over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with outcome</measure>
    <time_frame>Completion of study (estimated to be 30 months)</time_frame>
    <description>-The satisfaction with outcome module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-3. Upon completion of this component of the survey, a specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with breasts</measure>
    <time_frame>Completion of study (estimated to be 30 months)</time_frame>
    <description>-The satisfaction with breast module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-4. Upon completion of this component of the survey, a specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a</measure>
    <time_frame>Completion of study (estimated to be 30 months)</time_frame>
    <description>-Questions regarding upper extremity function as reported by patient. Answers range from 5=without any difficulty to 1=unable to do. The total score ranges from 5-35.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Post-mastectomy Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Participants with prepectoral reconstruction</arm_group_label>
    <description>-Participants will complete the post-mastectomy breast reconstruction physical well-being survey</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants with postpectoral reconstruction</arm_group_label>
    <description>-Participants will complete the post-mastectomy breast reconstruction physical well-being survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-mastectomy breast reconstruction physical well-being survey</intervention_name>
    <description>-The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.</description>
    <arm_group_label>Participants with postpectoral reconstruction</arm_group_label>
    <arm_group_label>Participants with prepectoral reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who undergone breast reconstruction surgery with plastic surgery faculty at&#xD;
        the Washington University School of Medicine Division of Plastic and Reconstructive&#xD;
        Surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Had a mastectomy for breast cancer or cancer prevention any time between 01/01/2010&#xD;
             and 06/30/2021.&#xD;
&#xD;
          -  Has undergone breast reconstruction surgery with plastic surgery faculty at the&#xD;
             Washington University School of Medicine Division of Plastic and Reconstructive&#xD;
             Surgery.&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Known distant metastatic disease&#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>Terence Myckatyn, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Terence Myckatyn, M.D.</last_name>
    <phone>314-996-3255</phone>
    <email>myckatyn@wustl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Terence Myckatyn, M.D.</last_name>
      <phone>314-996-3255</phone>
      <email>myckatyn@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Terence Myckatyn, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Janessa Sullivan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Danielle Cooper, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Grace Keane</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julie Margenthaler, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marissa Tenenbaum, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477538
org study id: 202006199
nct id: NCT04477538
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this proposal is to broadly assess patient physical functioning following
      breast reconstruction.
observational model: Cohort
time perspective: Prospective
measure: Compare the physical well-being Q-score derived from the BREAST-Q between the two groups
time frame: Completion of study (estimated to be 30 months)
description: The physical well-being module is one of the domains of the BREAST-Q that can be administered in isolation. Patients answer specific questions with answers that range from 1-4 to 1-5. Upon completion of this component of the survey, a physical well-being-specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100. This same approach is used for all other domains of the BREAST-Q. Pre- versus postoperative Q-scores for physical well-being can be directly compared to study the impact of surgery on physical well-being. Similarly, the physical-well-being domain can be readministered to provide a longitudinal assessment of physical function over time.
measure: Satisfaction with outcome
time frame: Completion of study (estimated to be 30 months)
description: -The satisfaction with outcome module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-3. Upon completion of this component of the survey, a specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100.
measure: Satisfaction with breasts
time frame: Completion of study (estimated to be 30 months)
description: -The satisfaction with breast module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-4. Upon completion of this component of the survey, a specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100.
measure: Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a
time frame: Completion of study (estimated to be 30 months)
description: -Questions regarding upper extremity function as reported by patient. Answers range from 5=without any difficulty to 1=unable to do. The total score ranges from 5-35.
arm group label: Participants with prepectoral reconstruction
description: -Participants will complete the post-mastectomy breast reconstruction physical well-being survey
arm group label: Participants with postpectoral reconstruction
description: -Participants will complete the post-mastectomy breast reconstruction physical well-being survey
intervention type: Other
intervention name: Post-mastectomy breast reconstruction physical well-being survey
description: -The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.
arm group label: Participants with postpectoral reconstruction
arm group label: Participants with prepectoral reconstruction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Terence Myckatyn, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Terence Myckatyn, M.D.
phone: 314-996-3255
email: myckatyn@wustl.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
sharing ipd: No