<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/NCT03822988</url>
  </required_header>
  <id_info>
    <org_study_id>PSS-2018/PADAONCODERM</org_study_id>
    <nct_id>NCT03822988</nct_id>
  </id_info>
  <brief_title>ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS</brief_title>
  <acronym>PADAONCODERM</acronym>
  <official_title>ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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 law about advance directives is evolving but, in France, few people write it.&#xD;
&#xD;
      Te main endpoint of this research is to estimate the proportion of patients who have written&#xD;
      their advance directives or considering doing so in onco-dermatologic population. If this&#xD;
      rate remains low, some insights on the reasons will be able to be advanced looking at the&#xD;
      point of view and opinion of patients about this topic.&#xD;
&#xD;
      Seconds endpoints are :&#xD;
&#xD;
      For patients against or not planning to write it, understand their reasons&#xD;
&#xD;
      Estimate the proportion of patients requesting information and understand how they would like&#xD;
      to receive it.&#xD;
&#xD;
      Investigate a possible association between the stage of the oncological disease and the&#xD;
      positioning of the patient concerning advance directives.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Writing by the patient of its advance directives</measure>
    <time_frame>when the patient complete the survey</time_frame>
    <description>Writing by the patient of his advance directves and, if not writing, positioning of the patient (rather favorable or rather unfavorable) as to the writing of his advance directives.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reason for not writing advance directives</measure>
    <time_frame>when the patient complete the survey</time_frame>
    <description>In patients who have not written their advance directives: reason for not writing the advance directives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient wishing to be more informed about the adavance directives during its management and, if so, by what means.</measure>
    <time_frame>when the patient complete the survey</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Advance Directives</condition>
  <condition>Oncology</condition>
  <condition>Skin Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Skin Lymphoma</condition>
  <condition>Skin Squamous Cell Carcinoma</condition>
  <condition>Metastatic Basal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>patients accepting to answer to the survey</arm_group_label>
    <description>patients with a skin lymphoma OR melanoma OR advanced skin squamous cell carcinoma OR advanced basal cell carcinoma accepting to answer to the anonymous survey</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention, only complete a survey</intervention_name>
    <description>we will ask patients to answer to a survey</description>
    <arm_group_label>patients accepting to answer to the survey</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cf beyond&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &gt; 18 ya&#xD;
&#xD;
        With one of the diagnoses below:&#xD;
&#xD;
          -  Melanoma&#xD;
&#xD;
          -  Skin lymphoma&#xD;
&#xD;
          -  Meckel Carcinoma&#xD;
&#xD;
          -  localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients not in possession of all of its cognitive abilities Patients who can't read&#xD;
        patients who don't speak 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>
  <overall_official>
    <last_name>anne-claire bursztejn</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Nancy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne-Claire BURSZTEJN</last_name>
    <phone>0383157146</phone>
    <email>ac-bursztejn@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU Nancy-Brabois hospital</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>anne-claire Bursztejn</last_name>
      <email>ac-bursztejn@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advance directives</keyword>
  <keyword>Advance care planning</keyword>
  <keyword>Patient's informed</keyword>
  <keyword>treatment preferences</keyword>
  <keyword>skin cancer</keyword>
  <keyword>dermatology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Basal Cell</mesh_term>
    <mesh_term>Skin 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/NCT03822988
org study id: PSS-2018/PADAONCODERM
nct id: NCT03822988
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The law about advance directives is evolving but, in France, few people write it.

      Te main endpoint of this research is to estimate the proportion of patients who have written
      their advance directives or considering doing so in onco-dermatologic population. If this
      rate remains low, some insights on the reasons will be able to be advanced looking at the
      point of view and opinion of patients about this topic.

      Seconds endpoints are :

      For patients against or not planning to write it, understand their reasons

      Estimate the proportion of patients requesting information and understand how they would like
      to receive it.

      Investigate a possible association between the stage of the oncological disease and the
      positioning of the patient concerning advance directives.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Writing by the patient of its advance directives
time frame: when the patient complete the survey
description: Writing by the patient of his advance directves and, if not writing, positioning of the patient (rather favorable or rather unfavorable) as to the writing of his advance directives.
measure: reason for not writing advance directives
time frame: when the patient complete the survey
description: In patients who have not written their advance directives: reason for not writing the advance directives.
measure: Patient wishing to be more informed about the adavance directives during its management and, if so, by what means.
time frame: when the patient complete the survey
arm group label: patients accepting to answer to the survey
description: patients with a skin lymphoma OR melanoma OR advanced skin squamous cell carcinoma OR advanced basal cell carcinoma accepting to answer to the anonymous survey
intervention type: Other
intervention name: no intervention, only complete a survey
description: we will ask patients to answer to a survey
arm group label: patients accepting to answer to the survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: anne-claire bursztejn
role: Principal Investigator
affiliation: CHRU Nancy
last name: Anne-Claire BURSZTEJN
phone: 0383157146
email: ac-bursztejn@chru-nancy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Basal Cell
mesh term: Skin Neoplasms
sharing ipd: No