<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/NCT03261323</url>
  </required_header>
  <id_info>
    <org_study_id>CASE10116</org_study_id>
    <nct_id>NCT03261323</nct_id>
  </id_info>
  <brief_title>Breast Reconstruction Following Breast Cancer in Very High Risk Patients</brief_title>
  <official_title>Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to:&#xD;
&#xD;
        1. Evaluate whether immediate or delayed reconstruction should be offered for breast&#xD;
           reconstruction candidates with higher risk for surgical complications by comparing&#xD;
           complications, quality of life, and hospital costs&#xD;
&#xD;
        2. Determine the efficacy of risk reduction strategies for breast reconstruction patients&#xD;
           with higher risk for surgical complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Endpoint(s)&#xD;
&#xD;
        1. Define the optimal timing of reconstruction in patients at a higher risk for developing&#xD;
           breast reconstruction surgical complications through a randomized prospective cohort&#xD;
&#xD;
        2. Compare immediate and delayed reconstruction outcome metrics through retrospective&#xD;
           review&#xD;
&#xD;
      Secondary Endpoint(s)&#xD;
&#xD;
        1. Evaluate Quality of life of patients at a higher risk for developing breast&#xD;
           reconstruction surgical complications undergoing immediate versus delayed&#xD;
           reconstruction.&#xD;
&#xD;
        2. Compare complications and reoperations between immediate versus delayed reconstruction.&#xD;
&#xD;
        3. Compare the hospital costs between immediate versus delayed reconstruction&#xD;
&#xD;
        4. Evaluate the effectiveness of risk reduction strategies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    insufficient staff&#xD;
  </why_stopped>
  <start_date type="Actual">May 31, 2019</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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>optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>Proportion of patients preferring delayed reconstruction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major complications</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor complications</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>defined as the ones that were office treated, not requiring a reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of revision surgeries</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital cost of the complete reconstruction treatment</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>Cost of reconstruction including the cost of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient satisfaction</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Aesthetic evaluation</measure>
    <time_frame>Until 1 year post breast reconstruction</time_frame>
    <description>Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Malignant Neoplasm of Breast</condition>
  <arm_group>
    <arm_group_label>Immediate breast reconstruction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed breast reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate Breast Reconstruction</intervention_name>
    <description>Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.</description>
    <arm_group_label>Immediate breast reconstruction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed Breast Reconstruction</intervention_name>
    <description>Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.</description>
    <arm_group_label>Delayed breast reconstruction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breast-Q questionnaire</intervention_name>
    <description>Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment</description>
    <arm_group_label>Delayed breast reconstruction</arm_group_label>
    <arm_group_label>Immediate breast reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically or cytologically confirmed breast cancer or&#xD;
             indication for prophylactic mastectomy.&#xD;
&#xD;
          -  Subjects must be breast reconstruction candidates using implant based breast&#xD;
             reconstruction.&#xD;
&#xD;
          -  Subjects must have a pre-operative risk &gt;20% complication prediction from the Breast&#xD;
             Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction&#xD;
             candidates&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior breast cancer surgical treatment&#xD;
&#xD;
          -  Prior breast reconstruction&#xD;
&#xD;
          -  Inability to provide written consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Risal Djohan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Reconstruction</keyword>
  <keyword>Mastectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>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/NCT03261323
org study id: CASE10116
nct id: NCT03261323
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to:

        1. Evaluate whether immediate or delayed reconstruction should be offered for breast
           reconstruction candidates with higher risk for surgical complications by comparing
           complications, quality of life, and hospital costs

        2. Determine the efficacy of risk reduction strategies for breast reconstruction patients
           with higher risk for surgical complications
Primary Endpoint(s)

        1. Define the optimal timing of reconstruction in patients at a higher risk for developing
           breast reconstruction surgical complications through a randomized prospective cohort

        2. Compare immediate and delayed reconstruction outcome metrics through retrospective
           review

      Secondary Endpoint(s)

        1. Evaluate Quality of life of patients at a higher risk for developing breast
           reconstruction surgical complications undergoing immediate versus delayed
           reconstruction.

        2. Compare complications and reoperations between immediate versus delayed reconstruction.

        3. Compare the hospital costs between immediate versus delayed reconstruction

        4. Evaluate the effectiveness of risk reduction strategies
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
time frame: Until 1 year post breast reconstruction
description: Proportion of patients preferring delayed reconstruction.
measure: Major complications
time frame: Until 1 year post breast reconstruction
description: defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
measure: Minor complications
time frame: Until 1 year post breast reconstruction
description: defined as the ones that were office treated, not requiring a reoperation
measure: Number of revision surgeries
time frame: Until 1 year post breast reconstruction
description: defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
measure: Hospital cost of the complete reconstruction treatment
time frame: Until 1 year post breast reconstruction
description: Cost of reconstruction including the cost of complications
measure: Change in patient satisfaction
time frame: Until 1 year post breast reconstruction
description: Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up
measure: Aesthetic evaluation
time frame: Until 1 year post breast reconstruction
description: Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery
arm group label: Immediate breast reconstruction
arm group type: Active Comparator
description: The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
arm group label: Delayed breast reconstruction
arm group type: Experimental
description: Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
intervention type: Procedure
intervention name: Immediate Breast Reconstruction
description: Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.
arm group label: Immediate breast reconstruction
intervention type: Procedure
intervention name: Delayed Breast Reconstruction
description: Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.
arm group label: Delayed breast reconstruction
intervention type: Other
intervention name: Breast-Q questionnaire
description: Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment
arm group label: Delayed breast reconstruction
arm group label: Immediate breast reconstruction
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Risal Djohan, MD
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplasms