<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/NCT03289286</url>
  </required_header>
  <id_info>
    <org_study_id>17SEIN04</org_study_id>
    <nct_id>NCT03289286</nct_id>
  </id_info>
  <brief_title>Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer</brief_title>
  <acronym>PITCA</acronym>
  <official_title>Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Claudius Regaud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Claudius Regaud</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>
      This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative&#xD;
      e-follow-up protocol in patients with ambulatory surgery for breast cancer.&#xD;
&#xD;
      This protocol will be based on:&#xD;
&#xD;
        -  A coordinated ambulatory follow-up performed by a dedicated nurse&#xD;
&#xD;
        -  An electronic follow-up tool used in pre- and post-surgery&#xD;
&#xD;
      Patients will be followed 8 days before the surgery until 30 days after the surgery of breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">June 29, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.</measure>
    <time_frame>1.5 months by patient</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction to the e-follow-up.</measure>
    <time_frame>1.5 months by patient</time_frame>
    <description>Satisfaction will be evaluated by questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of patients who discontinue the study 8 days before the surgery.</measure>
    <time_frame>1.5 months by patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of unplanned visits into the Center after ambulatory surgery in the first 24 hours and during the first 30 days will be assessed for each patient.</measure>
    <time_frame>1.5 months by patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with at least one unplanned visit.</measure>
    <time_frame>1.5 months by patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time spent by the dedicated nurse for the follow-up protocol management.</measure>
    <time_frame>1.5 months by patient</time_frame>
    <description>It will be defined as the sum of the time spent at different stages: initial training of patients, tracking of the connections to the tool, tracking of the alerts and telephone contacts.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with breast cancer operated in ambulatory</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dedicated and coordinated e-follow-up.</intervention_name>
    <description>In pre- and post-surgery:&#xD;
Completion of questionnaires using an electronic tool,&#xD;
Telephone follow-up if necessary between the nurse and the patient.</description>
    <arm_group_label>Patients with breast cancer operated in ambulatory</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient eligible for an ambulatory surgery of breast cancer (partial mastectomy with&#xD;
             or without lymph node sampling)&#xD;
&#xD;
          2. Ambulatory surgery planned 10 days or more after inclusion date&#xD;
&#xD;
          3. Age &gt; or = 18 years old&#xD;
&#xD;
          4. Affiliated to the french social security system&#xD;
&#xD;
          5. Patient must provide written informed consent prior to any study-specific procedure or&#xD;
             assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Surgery other than breast cancer surgery in ambulatory (benign breast surgery, other&#xD;
             surgical specialities)&#xD;
&#xD;
          2. Patient who cannot connect to the electronic tool at home (no computer, no tablet&#xD;
             computer or no internet connection)&#xD;
&#xD;
          3. Pregnant or breastfeeding women&#xD;
&#xD;
          4. Any psychological, familial, geographic or social situation, according to the judgment&#xD;
             of investigator, potentially preventing the provision of informed consent or&#xD;
             compliance to study procedure&#xD;
&#xD;
          5. Patient protected by law&#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>Dimitri GANGLOFF</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Claudius Regaud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Claudius Regaud IUCT-ONCOPOLE</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Ambulatory surgery</keyword>
  <keyword>Electronic tool</keyword>
  <keyword>e-follow-up</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/NCT03289286
org study id: 17SEIN04
nct id: NCT03289286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative
      e-follow-up protocol in patients with ambulatory surgery for breast cancer.

      This protocol will be based on:

        -  A coordinated ambulatory follow-up performed by a dedicated nurse

        -  An electronic follow-up tool used in pre- and post-surgery

      Patients will be followed 8 days before the surgery until 30 days after the surgery of breast
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Rate of patients without failure to the e-follow-up. A failure is defined by absence of connection to the electronic tool and the mismatch between the alert level and severity of complications.
time frame: 1.5 months by patient
measure: Patient satisfaction to the e-follow-up.
time frame: 1.5 months by patient
description: Satisfaction will be evaluated by questionnaire.
measure: The rate of patients who discontinue the study 8 days before the surgery.
time frame: 1.5 months by patient
measure: The number of unplanned visits into the Center after ambulatory surgery in the first 24 hours and during the first 30 days will be assessed for each patient.
time frame: 1.5 months by patient
measure: Rate of patients with at least one unplanned visit.
time frame: 1.5 months by patient
measure: The time spent by the dedicated nurse for the follow-up protocol management.
time frame: 1.5 months by patient
description: It will be defined as the sum of the time spent at different stages: initial training of patients, tracking of the connections to the tool, tracking of the alerts and telephone contacts.
arm group label: Patients with breast cancer operated in ambulatory
arm group type: Other
intervention type: Other
intervention name: Dedicated and coordinated e-follow-up.
description: In pre- and post-surgery:
Completion of questionnaires using an electronic tool,
Telephone follow-up if necessary between the nurse and the patient.
arm group label: Patients with breast cancer operated in ambulatory
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dimitri GANGLOFF
role: Principal Investigator
affiliation: Institut Claudius Regaud
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms