<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/NCT03246516</url>
  </required_header>
  <id_info>
    <org_study_id>2015_74</org_study_id>
    <secondary_id>2015-A01986-43</secondary_id>
    <nct_id>NCT03246516</nct_id>
  </id_info>
  <brief_title>Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers</brief_title>
  <acronym>DELOGAST</acronym>
  <official_title>Individual and Socio-economic Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lille Nord de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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 study evaluates the role of socioeconomic and individual factors in the onset of the&#xD;
      first symptoms of cancer and the first consultation with a doctor (patient delay) in&#xD;
      oeso-gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reducing the time between the onset of the first symptoms of cancer and the first&#xD;
      consultation with a doctor (patient delay) is essential to improve the vital prognosis and&#xD;
      quality of life of patients. Recent data suggest that some sociocognitive and emotional&#xD;
      determinants may explain patient delay from a complementary point of view. The main objective&#xD;
      of this study is to assess whether, in oeso-gastric cancer, patient delay is linked to these&#xD;
      sociocognitive and emotional factors, in addition to previously known factors.&#xD;
&#xD;
      We intend to include in this study 300 patients with a not yet treated oeso-gastric cancer&#xD;
      diagnosed in one of 10 health centres in the North of France region. The collected data will&#xD;
      be analysed to underline the differences between patients who consulted a doctor earlier&#xD;
      versus those who consulted later with a cut off at 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time limit of first doctor consultation</measure>
    <time_frame>baseline</time_frame>
    <description>Median time between date of symptoms appearance and date of first consultation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time limit of system of care</measure>
    <time_frame>baseline</time_frame>
    <description>Median time between date of he beginning of clinical investigations and the beginning of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cTNM Stage</measure>
    <time_frame>baseline</time_frame>
    <description>Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical variables (i.e medical history, symptoms, entry into care pathway)</measure>
    <time_frame>baseline</time_frame>
    <description>clinical variables associated with time of first doctor consultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socio-cognitive variables</measure>
    <time_frame>baseline</time_frame>
    <description>Socio-cognitive variables associated with time of first doctor consultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional variables</measure>
    <time_frame>baseline</time_frame>
    <description>Emotional variables associated with time of first doctor consultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>At 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Oesophageal Carcinoma</condition>
  <condition>Gastric Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Auto and hetero questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Auto and hetero questionnaires:&#xD;
STAI Y B, State-Trait Anxiety Inventoriage&#xD;
Brief COPE&#xD;
RHHI-24, Revised Health Hardiness Inventory&#xD;
IPQ-R, Illness Perception Questionnaire</description>
    <arm_group_label>Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  oesophageal, oeso-gastric junction or gastric cancer non treated cancer&#xD;
&#xD;
          -  patient informed of his diagnosis&#xD;
&#xD;
          -  speak fluent french&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of cancer&#xD;
&#xD;
          -  psychological history&#xD;
&#xD;
          -  patient under guardianship-&#xD;
&#xD;
          -  fortuitous diagnosis of cancer&#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>Guillaume Piessen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de Boulogne sur mer</name>
      <address>
        <city>Boulogne-sur-Mer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Béthune</name>
      <address>
        <city>Béthune</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Calais</name>
      <address>
        <city>Calais</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>centre Léonard de Vinci</name>
      <address>
        <city>Dechy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d 'oncologie Dunkerquois</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU, Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre oscar Lambret</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Roubaix</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Seclin</name>
      <address>
        <city>Seclin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</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>Esophageal 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/NCT03246516
org study id: 2015_74
secondary id: 2015-A01986-43
nct id: NCT03246516
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the role of socioeconomic and individual factors in the onset of the
      first symptoms of cancer and the first consultation with a doctor (patient delay) in
      oeso-gastric cancer.
Reducing the time between the onset of the first symptoms of cancer and the first
      consultation with a doctor (patient delay) is essential to improve the vital prognosis and
      quality of life of patients. Recent data suggest that some sociocognitive and emotional
      determinants may explain patient delay from a complementary point of view. The main objective
      of this study is to assess whether, in oeso-gastric cancer, patient delay is linked to these
      sociocognitive and emotional factors, in addition to previously known factors.

      We intend to include in this study 300 patients with a not yet treated oeso-gastric cancer
      diagnosed in one of 10 health centres in the North of France region. The collected data will
      be analysed to underline the differences between patients who consulted a doctor earlier
      versus those who consulted later with a cut off at 8 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Time limit of first doctor consultation
time frame: baseline
description: Median time between date of symptoms appearance and date of first consultation
measure: Time limit of system of care
time frame: baseline
description: Median time between date of he beginning of clinical investigations and the beginning of treatment
measure: cTNM Stage
time frame: baseline
description: Stage TNM by distinguishing the early stages (I, II) vs. (III, IV)
measure: clinical variables (i.e medical history, symptoms, entry into care pathway)
time frame: baseline
description: clinical variables associated with time of first doctor consultation
measure: Socio-cognitive variables
time frame: baseline
description: Socio-cognitive variables associated with time of first doctor consultation
measure: Emotional variables
time frame: baseline
description: Emotional variables associated with time of first doctor consultation
measure: Survival
time frame: At 3 years
arm group label: Questionnaire
arm group type: Experimental
description: Auto and hetero questionnaire
intervention type: Other
intervention name: Questionnaire
description: Auto and hetero questionnaires:
STAI Y B, State-Trait Anxiety Inventoriage
Brief COPE
RHHI-24, Revised Health Hardiness Inventory
IPQ-R, Illness Perception Questionnaire
arm group label: Questionnaire
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Piessen, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: No