<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/NCT03260946</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0217</org_study_id>
    <nct_id>NCT03260946</nct_id>
  </id_info>
  <brief_title>The Use of Alternative Medicine by Palliative Care Patients</brief_title>
  <official_title>The Use of Complementary Medicine in Palliative/Supportive Care Centres in Lyon, France</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>
      Palliative care centres in Lyon, France as well as the disclosure of Complementary and&#xD;
      Alternative Medicine and conventional healthcare use to conventional and Complementary and&#xD;
      Alternative Medicine practitioners respectively.&#xD;
&#xD;
      These aims will be achieved through the following objectives:&#xD;
&#xD;
        1. Describe the prevalence of Complementary and Alternative Medicine practitioner and&#xD;
           product use in the outpatient population of palliative care centres in Lyon, France&#xD;
&#xD;
        2. Describe the characteristics of Complementary and Alternative Medicine users the&#xD;
           outpatient population of palliative care centres in Lyon, France&#xD;
&#xD;
        3. Estimate the Complementary and Alternative Medicine expenditure of the outpatient&#xD;
           population of palliative care centres in Lyon, France&#xD;
&#xD;
        4. Describe the rates of disclosure of both Complementary and Alternative Medicine and&#xD;
           conventional health care to health professionals by the outpatient population of&#xD;
           palliative care centres in Lyon, France&#xD;
&#xD;
        5. Describe the reasons for disclosure or non-disclosure of both Complementary and&#xD;
           Alternative Medicine and conventional health care to health professionals by the&#xD;
           outpatient population of palliative care centres in Lyon, France&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2017</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complementary medicine use</measure>
    <time_frame>15 minutes</time_frame>
    <description>The prevalence of complementary medicine use. Data collected using a questionnaire.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Cancer</condition>
  <condition>Terminal Cancer</condition>
  <arm_group>
    <arm_group_label>Palliative/Supportive care</arm_group_label>
    <description>Individuals with cancer receiving palliative or supportive care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complementary medicine use</intervention_name>
    <description>The prevalence of complementary medicine use</description>
    <arm_group_label>Palliative/Supportive care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with cancer receiving palliative or supportive care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients accessing care from a palliative/supportive care centre in Lyon, France&#xD;
&#xD;
          2. Can read and understand French&#xD;
&#xD;
          3. Has been diagnosed with cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The primary health condition for which they are attending the centre is not cancer&#xD;
&#xD;
          2. They are not able to read and understand French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>USP de Charmettes - Croix rouge française</name>
      <address>
        <city>Lyon</city>
        <zip>69006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service E.M.S.P. Groupement Hospitalier Nord - Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Soins Palliatifs Lyon-Sud Pavillon 1K - Centre Hospitalier Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03260946
org study id: 69HCL17_0217
nct id: NCT03260946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Palliative care centres in Lyon, France as well as the disclosure of Complementary and
      Alternative Medicine and conventional healthcare use to conventional and Complementary and
      Alternative Medicine practitioners respectively.

      These aims will be achieved through the following objectives:

        1. Describe the prevalence of Complementary and Alternative Medicine practitioner and
           product use in the outpatient population of palliative care centres in Lyon, France

        2. Describe the characteristics of Complementary and Alternative Medicine users the
           outpatient population of palliative care centres in Lyon, France

        3. Estimate the Complementary and Alternative Medicine expenditure of the outpatient
           population of palliative care centres in Lyon, France

        4. Describe the rates of disclosure of both Complementary and Alternative Medicine and
           conventional health care to health professionals by the outpatient population of
           palliative care centres in Lyon, France

        5. Describe the reasons for disclosure or non-disclosure of both Complementary and
           Alternative Medicine and conventional health care to health professionals by the
           outpatient population of palliative care centres in Lyon, France
observational model: Cohort
time perspective: Prospective
measure: Complementary medicine use
time frame: 15 minutes
description: The prevalence of complementary medicine use. Data collected using a questionnaire.
arm group label: Palliative/Supportive care
description: Individuals with cancer receiving palliative or supportive care
intervention type: Other
intervention name: Complementary medicine use
description: The prevalence of complementary medicine use
arm group label: Palliative/Supportive care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No