<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/NCT03039348</url>
  </required_header>
  <id_info>
    <org_study_id>v2.0-11/01/2017-LauraM</org_study_id>
    <nct_id>NCT03039348</nct_id>
  </id_info>
  <brief_title>Opting for Breast Reconstruction After Mastectomy or Not: Search for Influencing Factors</brief_title>
  <official_title>Keuze Voor Wel of Geen Borstreconstructie na Mastectomie: Onderzoek Naar beïnvloedende Factoren</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the factors influencing the decision about breast&#xD;
      reconstruction after breast amputation for breast cancer.&#xD;
&#xD;
      The study will be conducted at the University Hospital in Brussels using only a&#xD;
      questionnaire. The results might help us to evaluate and improve the satisfaction among&#xD;
      patients about the received information and guidance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The questionnaire will be completed during one interview. This interview will take place&#xD;
      preferably right after the patient visited her doctor at the Breast Clinic at the University&#xD;
      Hospital in Brussels.&#xD;
&#xD;
      Before starting the interview all the necessary information to decide whether or not to&#xD;
      participate in the study will be given as well as the time to read the informed consent&#xD;
      carefully.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)</measure>
    <time_frame>december 2016 - may 2017</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Mastectomy</condition>
  <condition>Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Breast reconstruction</arm_group_label>
    <description>The patients choosing for breast reconstruction after mastectomy for breast cancer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No breast reconstruction</arm_group_label>
    <description>The patients not choosing breast reconstruction after mastectomy for breast cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>semi-structured interview using a questionnaire</intervention_name>
    <description>semi-structured interview using a questionnaire</description>
    <arm_group_label>Breast reconstruction</arm_group_label>
    <arm_group_label>No breast reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the Breast Clinic at the University Hospital in Brussels.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  Dutch speaking&#xD;
&#xD;
          -  must have undergone a mastectomy for breast cancer in the following period: 2010 -&#xD;
             2015&#xD;
&#xD;
          -  must be a patient of the Breast Clinic at the University Hospital in Brussels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral preventive mastectomy (and therefore no history of breast cancer in any of&#xD;
             the breasts)&#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>Laura Mettepenningen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <reference>
    <citation>Ananian P, Houvenaeghel G, Protiere C, Rouanet P, Arnaud S, Moatti JP, Tallet A, Braud AC, Julian-Reynier C. Determinants of patients' choice of reconstruction with mastectomy for primary breast cancer. Ann Surg Oncol. 2004 Aug;11(8):762-71. doi: 10.1245/ASO.2004.11.027. Epub 2004 Jul 12.</citation>
    <PMID>15249342</PMID>
  </reference>
  <reference>
    <citation>Fallbjork U, Karlsson S, Salander P, Rasmussen BH. Differences between women who have and have not undergone breast reconstruction after mastectomy due to breast cancer. Acta Oncol. 2010;49(2):174-9. doi: 10.3109/02841860903490069.</citation>
    <PMID>20100155</PMID>
  </reference>
  <reference>
    <citation>Duggal CS, Metcalfe D, Sackeyfio R, Carlson GW, Losken A. Patient motivations for choosing postmastectomy breast reconstruction. Ann Plast Surg. 2013 May;70(5):574-80. doi: 10.1097/SAP.0b013e3182851052.</citation>
    <PMID>23542859</PMID>
  </reference>
  <reference>
    <citation>Gopie JP, Hilhorst MT, Kleijne A, Timman R, Menke-Pluymers MB, Hofer SO, Mureau MA, Tibben A. Women's motives to opt for either implant or DIEP-flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2011 Aug;64(8):1062-7. doi: 10.1016/j.bjps.2011.03.030. Epub 2011 Apr 22.</citation>
    <PMID>21514261</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Laura Mettepenningen</investigator_full_name>
    <investigator_title>student</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer Female</keyword>
  <keyword>Mastectomy</keyword>
  <keyword>Breast Reconstruction</keyword>
  <keyword>questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>undecided</ipd_description>
  </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/NCT03039348
org study id: v2.0-11/01/2017-LauraM
nct id: NCT03039348
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the factors influencing the decision about breast
      reconstruction after breast amputation for breast cancer.

      The study will be conducted at the University Hospital in Brussels using only a
      questionnaire. The results might help us to evaluate and improve the satisfaction among
      patients about the received information and guidance.
The questionnaire will be completed during one interview. This interview will take place
      preferably right after the patient visited her doctor at the Breast Clinic at the University
      Hospital in Brussels.

      Before starting the interview all the necessary information to decide whether or not to
      participate in the study will be given as well as the time to read the informed consent
      carefully.
observational model: Case-Control
time perspective: Cross-Sectional
measure: factors influencing the choice concerning breast reconstruction after mastectomy, assessed with a questionnaire (with multiple choice and open questions)
time frame: december 2016 - may 2017
arm group label: Breast reconstruction
description: The patients choosing for breast reconstruction after mastectomy for breast cancer.
arm group label: No breast reconstruction
description: The patients not choosing breast reconstruction after mastectomy for breast cancer.
intervention type: Other
intervention name: semi-structured interview using a questionnaire
description: semi-structured interview using a questionnaire
arm group label: Breast reconstruction
arm group label: No 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: Laura Mettepenningen
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
citation: Ananian P, Houvenaeghel G, Protiere C, Rouanet P, Arnaud S, Moatti JP, Tallet A, Braud AC, Julian-Reynier C. Determinants of patients' choice of reconstruction with mastectomy for primary breast cancer. Ann Surg Oncol. 2004 Aug;11(8):762-71. doi: 10.1245/ASO.2004.11.027. Epub 2004 Jul 12.
PMID: 15249342
citation: Fallbjork U, Karlsson S, Salander P, Rasmussen BH. Differences between women who have and have not undergone breast reconstruction after mastectomy due to breast cancer. Acta Oncol. 2010;49(2):174-9. doi: 10.3109/02841860903490069.
PMID: 20100155
citation: Duggal CS, Metcalfe D, Sackeyfio R, Carlson GW, Losken A. Patient motivations for choosing postmastectomy breast reconstruction. Ann Plast Surg. 2013 May;70(5):574-80. doi: 10.1097/SAP.0b013e3182851052.
PMID: 23542859
citation: Gopie JP, Hilhorst MT, Kleijne A, Timman R, Menke-Pluymers MB, Hofer SO, Mureau MA, Tibben A. Women's motives to opt for either implant or DIEP-flap breast reconstruction. J Plast Reconstr Aesthet Surg. 2011 Aug;64(8):1062-7. doi: 10.1016/j.bjps.2011.03.030. Epub 2011 Apr 22.
PMID: 21514261
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Laura Mettepenningen
investigator title: student
mesh term: Breast Neoplasms
sharing ipd: Undecided
ipd description: undecided