<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/NCT04444882</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.120</org_study_id>
    <secondary_id>2020-A00966-33</secondary_id>
    <nct_id>NCT04444882</nct_id>
  </id_info>
  <brief_title>Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care</brief_title>
  <acronym>COTUKI</acronym>
  <official_title>Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      To make an inventory of the physiotherapeutic care and the post-operative complications of&#xD;
      patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.&#xD;
&#xD;
      The investigators expect to see a lack of consultation of physiotherapists by patients&#xD;
      despite a significant number of complications, impacting the quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is observational and descriptive. For this purpose, patients meeting the inclusion&#xD;
      and non-inclusion criteria can answer, if they wish, to an online questionnaire after having&#xD;
      read the information and non-opposition letter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">January 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment</measure>
    <time_frame>10 minutes</time_frame>
    <description>Answers to the questionnaire part 2 &quot;physiotherapy care&quot;. Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment</measure>
    <time_frame>10 minutes</time_frame>
    <description>Answers to the questionnaire part 2 &quot; post-operative complications &quot; Questions 16, 23, 27, 28.</description>
  </secondary_outcome>
  <enrollment type="Actual">71</enrollment>
  <condition>Breast Neoplasm</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study involves breast cancer patients who have undergone the following treatment:&#xD;
        lumpectomy, sentinel node and radiotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer Patients&#xD;
&#xD;
          -  Patients with a good command of French in order to understand the letter of&#xD;
             information and the questionnaire.&#xD;
&#xD;
          -  Patients treated at the &quot;Couple Enfant Hospital&quot; in Grenoble. We have chosen to take&#xD;
             patients who have been operated on at least 3 months ago (average time of end of&#xD;
             radiotherapy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient having undergone a mastectomy or chemotherapy&#xD;
&#xD;
          -  Patient with difficulties understanding, expressing or reading the French language&#xD;
&#xD;
          -  Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)&#xD;
&#xD;
          -  Patient subject to a legal protection measure or out of state to express her&#xD;
             opposition (guardianship, curatorship)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Bordin-Goffin</last_name>
    <role>Study Director</role>
    <affiliation>IFMK Saint Martin d'Hères</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postoperative complications</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>lumpectomy</keyword>
  <keyword>sentinel node</keyword>
  <keyword>radiotherapy</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>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/NCT04444882
org study id: 38RC20.120
secondary id: 2020-A00966-33
nct id: NCT04444882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To make an inventory of the physiotherapeutic care and the post-operative complications of
      patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.

      The investigators expect to see a lack of consultation of physiotherapists by patients
      despite a significant number of complications, impacting the quality of life.
This study is observational and descriptive. For this purpose, patients meeting the inclusion
      and non-inclusion criteria can answer, if they wish, to an online questionnaire after having
      read the information and non-opposition letter.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
time frame: 10 minutes
description: Answers to the questionnaire part 2 "physiotherapy care". Questions 17, 18, 19, 20, 21, 22, 24, 25, 26. (étude descriptive)
measure: Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
time frame: 10 minutes
description: Answers to the questionnaire part 2 " post-operative complications " Questions 16, 23, 27, 28.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Caroline Bordin-Goffin
role: Study Director
affiliation: IFMK Saint Martin d'Hères
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No