<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/NCT01723423</url>
  </required_header>
  <id_info>
    <org_study_id>10-PAF07150</org_study_id>
    <nct_id>NCT01723423</nct_id>
  </id_info>
  <brief_title>Mastectomy Reconstruction Outcomes Consortium (MROC) Study</brief_title>
  <acronym>MROC</acronym>
  <official_title>Mastectomy Reconstruction Outcomes Consortium (MROC) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Joseph Mercy Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Georgia Institute for Plastic Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Health &amp; Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MROC Study seeks to evaluate and compare from the patient's point of view the leading&#xD;
      options for breast reconstruction after mastectomy. This study will help patients,&#xD;
      physicians, payers and policy makers better understand the various surgeries available for&#xD;
      breast reconstruction. Although many women choose reconstruction, the number of options as&#xD;
      well as their pros and cons can make decision making difficult and stressful. From this&#xD;
      research, we hope to learn more about what works best for patients undergoing these&#xD;
      operations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the growing use of breast conservation as primary therapy for breast cancer,&#xD;
      mastectomy remains a common treatment option. Many patients choose to undergo breast&#xD;
      reconstruction as an effective means of lessening the adverse impact of mastectomy on&#xD;
      psychosocial functioning and quality of life. Despite these benefits, well-designed studies&#xD;
      comparing the current choices from the patient's point of view are difficult (if not&#xD;
      impossible) to come by. Previous research on breast reconstruction outcomes has also failed&#xD;
      to include race and ethnicity as key variables. In order to actively participate in the&#xD;
      reconstruction decision making process, breast cancer survivors need objective, up-to-date&#xD;
      information on breast reconstruction outcomes from the patient's perspective.&#xD;
&#xD;
      The proposed Mastectomy Reconstruction Outcomes Consortium (MROC) Study will use a&#xD;
      prospective cohort design to compare outcomes for the eight commonly used options for breast&#xD;
      reconstruction: expander/implant, latissimus dorsi/implant (LD), pedicle transverse rectus&#xD;
      abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), deep inferior epigastric perforator&#xD;
      (DIEP), superficial inferior epigastric artery (SIEA), superior gluteal artery perforator&#xD;
      (SGAP) and inferior gluteal artery perforator (IGAP) techniques.&#xD;
&#xD;
      Outcomes assessed will include complications, postoperative pain, psychosocial well-being,&#xD;
      physical functioning, fatigue, patient satisfaction and costs. The project will also evaluate&#xD;
      the effects of race and ethnicity on reconstruction outcomes. Thirteen leading centers in the&#xD;
      United States and Canada will participate. Together, these institutions perform over 3000&#xD;
      breast reconstructions annually. The five year study will evaluate patients preoperatively&#xD;
      and at one week, three months, one year and two years following reconstruction. For data&#xD;
      sources, the project will rely on medical and billing records, as well as a panel of generic&#xD;
      and condition-specific patient-report outcome measures.&#xD;
&#xD;
      The MROC Study will benefit a variety of stakeholders in the healthcare marketplace: The&#xD;
      project will provide consumers, providers, payers, and policy-makers with reliable,&#xD;
      up-to-date information on the effectiveness and relative costs of surgical options for breast&#xD;
      reconstruction, thereby promoting a more evidence-based approach to treatment and policy&#xD;
      decision-making. Study findings will also assist health care organizations in designing&#xD;
      systems of care tailored to the specific needs and preferences of diverse patient&#xD;
      populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in health-related quality of life.</measure>
    <time_frame>Change from baseline at 1 week, 3 months, 1 year and 2 years post-operatively.</time_frame>
    <description>Patient reported outcome measures will include patient satisfaction, post-operative pain, body image, psycho-social functioning, physical functioning, and fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of race and ethnicity on reconstruction outcomes.</measure>
    <time_frame>Pre-operatively and at 1 week, 3 months, 1 year and 2 years postoperatively</time_frame>
    <description>Although the study will not be adequately powered to analyze outcomes by procedure type within racial and ethnic categories, we will obtain descriptive statistics for the effects of race and ethnicity on breast reconstruction outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive statistics on the relative costs of the eight procedure types.</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures.</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">4436</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Expander/Implant</arm_group_label>
    <description>Patients receiving expander/implant breast reconstruction procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lat Dorsi</arm_group_label>
    <description>Patients receiving latissimus dorsi breast reconstructions with or without implant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTRAM</arm_group_label>
    <description>Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FTRAM</arm_group_label>
    <description>Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DIEP</arm_group_label>
    <description>Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIEA</arm_group_label>
    <description>Patients receiving superficial inferior epigastric artery (SIEA)breast reconstruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S-GAP</arm_group_label>
    <description>Patients receiving superior gluteal artery perforator breast reconstruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-GAP</arm_group_label>
    <description>Patients receiving inferior gluteal artery perforator breast reconstruction.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing first-time breast reconstruction at one of 11 consortium sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who present themselves for reconstruction at one of 11 MROC centers&#xD;
&#xD;
          -  Women undergoing one of the following types of breast reconstruction after mastectomy:&#xD;
             tissue expander/implant, LD flap (with, or without implant), PTRAM flap, FTRAM flap,&#xD;
             DIEP flap, S-GAP flap, I-GAP flap or SIEA flap.&#xD;
&#xD;
          -  Immediate or delayed reconstruction&#xD;
&#xD;
          -  Unilateral or bilateral reconstructions.&#xD;
&#xD;
          -  Women receiving mastectomy for cancer prophylaxis, without history of breast cancer,&#xD;
             will be eligible to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients electing reconstruction following complications of breast augmentation,&#xD;
             mastopexy (breast lift), or breast reduction will not be recruited for the study.&#xD;
&#xD;
          -  Procedures performed following previously failed attempts at breast reconstruction&#xD;
             will be excluded from the study, due to potential confounding by these previous&#xD;
             surgeries.&#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>Edwin G Wilkins, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea L. Pusic, MD, MHSA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington, D.C.</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute for Plastic Surgery</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Medical Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Mercy Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212-3154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health Care - University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wilkins EG, Cederna PS, Lowery JC, Davis JA, Kim HM, Roth RS, Goldfarb S, Izenberg PH, Houin HP, Shaheen KW. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2000 Oct;106(5):1014-25; discussion 1026-7. doi: 10.1097/00006534-200010000-00010.</citation>
    <PMID>11039373</PMID>
  </reference>
  <reference>
    <citation>Alderman AK, Kuhn LE, Lowery JC, Wilkins EG. Does patient satisfaction with breast reconstruction change over time? Two-year results of the Michigan Breast Reconstruction Outcomes Study. J Am Coll Surg. 2007 Jan;204(1):7-12. doi: 10.1016/j.jamcollsurg.2006.09.022. Epub 2006 Nov 16.</citation>
    <PMID>17189107</PMID>
  </reference>
  <reference>
    <citation>Alderman AK, Wilkins EG, Kim HM, Lowery JC. Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2002 Jun;109(7):2265-74. doi: 10.1097/00006534-200206000-00015.</citation>
    <PMID>12045548</PMID>
  </reference>
  <reference>
    <citation>Roth RS, Lowery JC, Davis J, Wilkins EG. Persistent pain following postmastectomy breast reconstruction: long-term effects of type and timing of surgery. Ann Plast Surg. 2007 Apr;58(4):371-6. doi: 10.1097/01.sap.0000239810.38137.84.</citation>
    <PMID>17413877</PMID>
  </reference>
  <reference>
    <citation>Hu ES, Pusic AL, Waljee JF, Kuhn L, Hawley ST, Wilkins E, Alderman AK. Patient-reported aesthetic satisfaction with breast reconstruction during the long-term survivorship Period. Plast Reconstr Surg. 2009 Jul;124(1):1-8. doi: 10.1097/PRS.0b013e3181ab10b2.</citation>
    <PMID>19568038</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>February 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Edwin G. Wilkins</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>evidence based medicine</keyword>
  <keyword>reconstruction</keyword>
  <keyword>mastectomy</keyword>
  <keyword>outcomes</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723423
org study id: 10-PAF07150
nct id: NCT01723423
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The MROC Study seeks to evaluate and compare from the patient's point of view the leading
      options for breast reconstruction after mastectomy. This study will help patients,
      physicians, payers and policy makers better understand the various surgeries available for
      breast reconstruction. Although many women choose reconstruction, the number of options as
      well as their pros and cons can make decision making difficult and stressful. From this
      research, we hope to learn more about what works best for patients undergoing these
      operations.
Despite the growing use of breast conservation as primary therapy for breast cancer,
      mastectomy remains a common treatment option. Many patients choose to undergo breast
      reconstruction as an effective means of lessening the adverse impact of mastectomy on
      psychosocial functioning and quality of life. Despite these benefits, well-designed studies
      comparing the current choices from the patient's point of view are difficult (if not
      impossible) to come by. Previous research on breast reconstruction outcomes has also failed
      to include race and ethnicity as key variables. In order to actively participate in the
      reconstruction decision making process, breast cancer survivors need objective, up-to-date
      information on breast reconstruction outcomes from the patient's perspective.

      The proposed Mastectomy Reconstruction Outcomes Consortium (MROC) Study will use a
      prospective cohort design to compare outcomes for the eight commonly used options for breast
      reconstruction: expander/implant, latissimus dorsi/implant (LD), pedicle transverse rectus
      abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), deep inferior epigastric perforator
      (DIEP), superficial inferior epigastric artery (SIEA), superior gluteal artery perforator
      (SGAP) and inferior gluteal artery perforator (IGAP) techniques.

      Outcomes assessed will include complications, postoperative pain, psychosocial well-being,
      physical functioning, fatigue, patient satisfaction and costs. The project will also evaluate
      the effects of race and ethnicity on reconstruction outcomes. Thirteen leading centers in the
      United States and Canada will participate. Together, these institutions perform over 3000
      breast reconstructions annually. The five year study will evaluate patients preoperatively
      and at one week, three months, one year and two years following reconstruction. For data
      sources, the project will rely on medical and billing records, as well as a panel of generic
      and condition-specific patient-report outcome measures.

      The MROC Study will benefit a variety of stakeholders in the healthcare marketplace: The
      project will provide consumers, providers, payers, and policy-makers with reliable,
      up-to-date information on the effectiveness and relative costs of surgical options for breast
      reconstruction, thereby promoting a more evidence-based approach to treatment and policy
      decision-making. Study findings will also assist health care organizations in designing
      systems of care tailored to the specific needs and preferences of diverse patient
      populations.
observational model: Cohort
time perspective: Prospective
measure: Change from baseline in health-related quality of life.
time frame: Change from baseline at 1 week, 3 months, 1 year and 2 years post-operatively.
description: Patient reported outcome measures will include patient satisfaction, post-operative pain, body image, psycho-social functioning, physical functioning, and fatigue.
measure: The effects of race and ethnicity on reconstruction outcomes.
time frame: Pre-operatively and at 1 week, 3 months, 1 year and 2 years postoperatively
description: Although the study will not be adequately powered to analyze outcomes by procedure type within racial and ethnic categories, we will obtain descriptive statistics for the effects of race and ethnicity on breast reconstruction outcomes.
measure: Descriptive statistics on the relative costs of the eight procedure types.
time frame: 2 years postoperatively
description: Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures.
arm group label: Expander/Implant
description: Patients receiving expander/implant breast reconstruction procedures.
arm group label: Lat Dorsi
description: Patients receiving latissimus dorsi breast reconstructions with or without implant.
arm group label: PTRAM
description: Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction.
arm group label: FTRAM
description: Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.)
arm group label: DIEP
description: Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions.
arm group label: SIEA
description: Patients receiving superficial inferior epigastric artery (SIEA)breast reconstruction.
arm group label: S-GAP
description: Patients receiving superior gluteal artery perforator breast reconstruction.
arm group label: I-GAP
description: Patients receiving inferior gluteal artery perforator breast reconstruction.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edwin G Wilkins, MD, MS
role: Principal Investigator
affiliation: University of Michigan
last name: Andrea L. Pusic, MD, MHSA
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
citation: Wilkins EG, Cederna PS, Lowery JC, Davis JA, Kim HM, Roth RS, Goldfarb S, Izenberg PH, Houin HP, Shaheen KW. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2000 Oct;106(5):1014-25; discussion 1026-7. doi: 10.1097/00006534-200010000-00010.
PMID: 11039373
citation: Alderman AK, Kuhn LE, Lowery JC, Wilkins EG. Does patient satisfaction with breast reconstruction change over time? Two-year results of the Michigan Breast Reconstruction Outcomes Study. J Am Coll Surg. 2007 Jan;204(1):7-12. doi: 10.1016/j.jamcollsurg.2006.09.022. Epub 2006 Nov 16.
PMID: 17189107
citation: Alderman AK, Wilkins EG, Kim HM, Lowery JC. Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2002 Jun;109(7):2265-74. doi: 10.1097/00006534-200206000-00015.
PMID: 12045548
citation: Roth RS, Lowery JC, Davis J, Wilkins EG. Persistent pain following postmastectomy breast reconstruction: long-term effects of type and timing of surgery. Ann Plast Surg. 2007 Apr;58(4):371-6. doi: 10.1097/01.sap.0000239810.38137.84.
PMID: 17413877
citation: Hu ES, Pusic AL, Waljee JF, Kuhn L, Hawley ST, Wilkins E, Alderman AK. Patient-reported aesthetic satisfaction with breast reconstruction during the long-term survivorship Period. Plast Reconstr Surg. 2009 Jul;124(1):1-8. doi: 10.1097/PRS.0b013e3181ab10b2.
PMID: 19568038
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Edwin G. Wilkins
investigator title: Professor of Surgery
mesh term: Breast Neoplasms