<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/NCT03247504</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0436</org_study_id>
    <nct_id>NCT03247504</nct_id>
  </id_info>
  <brief_title>Adherence to Opioids in Oncology Out Patients</brief_title>
  <official_title>Adherence to Opioids in Oncology Out Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Cancer pain is undertreated despite a good access to opioids in France. Although many factors&#xD;
      are involved, the barriers related to the patient (and his family) are often reported .the&#xD;
      reluctance of the patient or the family to take the prescribed medication is linked to&#xD;
      misconceptions about the opioids , cultural barriers; or the lack of explanations provided by&#xD;
      the physician. Some patients can have undiagnosed slight cognitive impairment .The situation&#xD;
      is now more complicated as appear on the market the new form of opioids for the cancer&#xD;
      breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of&#xD;
      the study is to measure the adherence to opioids in cancer out patients and the associated&#xD;
      factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 17, 2018</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of cancer out patients with a low adherence to the opioids treatment</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cancer Out Patients With Opioids</condition>
  <eligibility>
    <study_pop>
      <textblock>
        cancer out patients with opioids treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer out patients with opioids by mouth prescription&#xD;
&#xD;
          -  Prescription than more than 8 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not at home, but in nursing home or other setting were the treatment are given&#xD;
             by medical staff&#xD;
&#xD;
          -  Patient unable to answer at the questionnaire&#xD;
&#xD;
          -  Opoids given Intravenous or other way than mouth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marilène FILBET</last_name>
    <phone>478861482</phone>
    <phone_ext>+33</phone_ext>
    <email>marilene.filbet@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre de Soins Palliatifs Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marilène FILBET, Pr</last_name>
      <phone>478861482</phone>
      <phone_ext>+33</phone_ext>
      <email>marilene.filbet@chu-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 4, 2019</last_update_submitted>
  <last_update_submitted_qc>October 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03247504
org study id: 69HCL17_0436
nct id: NCT03247504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer pain is undertreated despite a good access to opioids in France. Although many factors
      are involved, the barriers related to the patient (and his family) are often reported .the
      reluctance of the patient or the family to take the prescribed medication is linked to
      misconceptions about the opioids , cultural barriers; or the lack of explanations provided by
      the physician. Some patients can have undiagnosed slight cognitive impairment .The situation
      is now more complicated as appear on the market the new form of opioids for the cancer
      breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of
      the study is to measure the adherence to opioids in cancer out patients and the associated
      factors.
observational model: Cohort
time perspective: Cross-Sectional
measure: Rate of cancer out patients with a low adherence to the opioids treatment
time frame: One day
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marilène FILBET
phone: 478861482
phone ext: +33
email: marilene.filbet@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor