<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/NCT03775304</url>
  </required_header>
  <id_info>
    <org_study_id>NI10031</org_study_id>
    <nct_id>NCT03775304</nct_id>
  </id_info>
  <brief_title>Evaluation of End of Life Quality of Care</brief_title>
  <acronym>EFIQUAVIE</acronym>
  <official_title>Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The study uses a mixed method study to evaluate wether the use of the indicators of the&#xD;
      Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI:&#xD;
      10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of&#xD;
      study was designed to investigate the representations of quality by face-to face interviews&#xD;
      with family carer of recently deceased cancer patients, and with their oncologists, and&#xD;
      nurses. The quantitative part of the study, consisted in a decedents case series analysis,&#xD;
      diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were&#xD;
      collected from different complementary sources associating national mortality data, hospital&#xD;
      activity data, and health records.&#xD;
&#xD;
      The study was approved by the French data protection authority (CNIL) number 611273.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">December 15, 2015</completion_date>
  <primary_completion_date type="Actual">December 15, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Use of emergency services within last 30 days before death</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients received chemotherapy in the last 14 days of life</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of death</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Among patients who died in palliative care unit, those who died within 3 days after admission</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission in intensive care unit within last 30 days before death</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">997</enrollment>
  <condition>Neoplasm Malignant</condition>
  <condition>Quality of Life</condition>
  <condition>End of Life Care</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients deceased in 2010, among all patients identified in the DRG database of the 5&#xD;
        participating center with a diagnosis of metastatic cancer, during at least one stay&#xD;
        between Oct 1st, 2009 and Dec 31, 2010.&#xD;
&#xD;
        200 patients per study center were randomly selected for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patients aged ≥ 18,&#xD;
&#xD;
          -  diagnosed with advanced cancer (recruited from hospital activity data, by a stay with&#xD;
             a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)&#xD;
&#xD;
          -  deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from&#xD;
             hospital activity data, or from national mortality statistics)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis with non solid tumor (haematology)&#xD;
&#xD;
          -  age &lt; 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Hôpital Henri Mondor</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Death</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/NCT03775304
org study id: NI10031
nct id: NCT03775304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study uses a mixed method study to evaluate wether the use of the indicators of the
      Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI:
      10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of
      study was designed to investigate the representations of quality by face-to face interviews
      with family carer of recently deceased cancer patients, and with their oncologists, and
      nurses. The quantitative part of the study, consisted in a decedents case series analysis,
      diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were
      collected from different complementary sources associating national mortality data, hospital
      activity data, and health records.

      The study was approved by the French data protection authority (CNIL) number 611273.
observational model: Case-Only
time perspective: Retrospective
measure: Use of emergency services within last 30 days before death
time frame: Through study completion, up to 1 year
measure: Patients received chemotherapy in the last 14 days of life
time frame: Through study completion, up to 1 year
measure: Location of death
time frame: Through study completion, up to 1 year
measure: Among patients who died in palliative care unit, those who died within 3 days after admission
time frame: Through study completion, up to 1 year
measure: Admission in intensive care unit within last 30 days before death
time frame: Through study completion, up to 1 year
measure: Among patients with pain relief opioid treatment, those with combined short term and long acting opioid orders
time frame: Through study completion, up to 1 year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Death
sharing ipd: No