<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/NCT04401046</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-TRAUMA-IPC 2020-026</org_study_id>
    <nct_id>NCT04401046</nct_id>
  </id_info>
  <brief_title>COVID-19 and Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder</brief_title>
  <acronym>COVID-TRAUMA</acronym>
  <official_title>COVID-19 EPIDEMIC Reorganisation of Cancer Patient Care: Self- Evaluation of Potential Post-traumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</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 COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing&#xD;
      post-traumatic stress disorder, especially in cancer patients who feel more at risk of&#xD;
      contracting the virus, and fear developing serious symptoms. The study's primary objective is&#xD;
      to measure the presence of a potential post-traumatic stress disorder in cancer patients, and&#xD;
      to assess the associated factors. The secondary objectives are to measure patients' anxiety,&#xD;
      as well as their perception of both the management of their cancer care, and their fear of a&#xD;
      cancer recurrence.&#xD;
&#xD;
      It is a prospective, multi-centric study using self-assessing survey offered to cancer&#xD;
      patients currently under ongoing care or treatment. The surveys will be sent by post at the&#xD;
      beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000&#xD;
      patients will be contacted, over a period of 3 months, in order to receive 1600 responses,&#xD;
      and 640 responses 6 months later.&#xD;
&#xD;
      Researching the factors associated with the appearance of post-traumatic stress could lead to&#xD;
      better screening of patient disorders in highly anxiety-provoking crisis situations. As a&#xD;
      result, it would lead to an improvement of their care, healthcare organization, and their&#xD;
      follow-up in the case of a new epidemic or any other stressful event of this magnitude.&#xD;
      Furthermore, promoting the patient's expression capabilities favors their implication in&#xD;
      their care, and facilitates the development of health democracy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 26, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score of the Impact of Event Scale Revisited scale</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors associated with post-traumatic stress disorder</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
    <description>The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of the patient's anxiety</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
    <description>The measure of anxiety, measured by the State-Trait Anxiety Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients stating that remote consultation is as useful as a face-to-face consultation</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the cancer recurrence scale</measure>
    <time_frame>at inclusion and 6 months later</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1096</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Post traumatic stress and anxiety evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later</intervention_name>
    <description>The first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease).</description>
    <arm_group_label>Post traumatic stress and anxiety evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman, age&gt;18&#xD;
&#xD;
          -  Diagnosis of cancer (solid tumor or hematology)&#xD;
&#xD;
          -  Out patient or patient Under surveillance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Emergency, person deprived of liberty&#xD;
&#xD;
          -  hospitalized patient&#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>Gwenaelle GRAVIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>POST TRAUMATIC STRESS</keyword>
  <keyword>CANCER</keyword>
  <keyword>ANXIETY</keyword>
  <keyword>REORGANISATION OF CARE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT04401046
org study id: COVID-TRAUMA-IPC 2020-026
nct id: NCT04401046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic is a traumatic event which could lead to a greater risk of developing
      post-traumatic stress disorder, especially in cancer patients who feel more at risk of
      contracting the virus, and fear developing serious symptoms. The study's primary objective is
      to measure the presence of a potential post-traumatic stress disorder in cancer patients, and
      to assess the associated factors. The secondary objectives are to measure patients' anxiety,
      as well as their perception of both the management of their cancer care, and their fear of a
      cancer recurrence.

      It is a prospective, multi-centric study using self-assessing survey offered to cancer
      patients currently under ongoing care or treatment. The surveys will be sent by post at the
      beginning of the study, and again 6 months later. Expecting a participation rate of 40%, 4000
      patients will be contacted, over a period of 3 months, in order to receive 1600 responses,
      and 640 responses 6 months later.

      Researching the factors associated with the appearance of post-traumatic stress could lead to
      better screening of patient disorders in highly anxiety-provoking crisis situations. As a
      result, it would lead to an improvement of their care, healthcare organization, and their
      follow-up in the case of a new epidemic or any other stressful event of this magnitude.
      Furthermore, promoting the patient's expression capabilities favors their implication in
      their care, and facilitates the development of health democracy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Score of the Impact of Event Scale Revisited scale
time frame: at inclusion and 6 months later
measure: Factors associated with post-traumatic stress disorder
time frame: at inclusion and 6 months later
description: The factors associated with post traumatic stress, measured by the Impact of Event Scale Revisited scale
measure: Measure of the patient's anxiety
time frame: at inclusion and 6 months later
description: The measure of anxiety, measured by the State-Trait Anxiety Questionnaire
measure: proportion of patients perceiving poorer management of their cancer care since the start of the COVID-19 epidemic.
time frame: at inclusion and 6 months later
measure: proportion of patients perceiving the implementation of all necessary measures to reduce the risk of exposure to COVID-19
time frame: at inclusion and 6 months later
measure: proportion of patients stating that remote consultation is as useful as a face-to-face consultation
time frame: at inclusion and 6 months later
measure: proportion of patients with access to a clinical psychology consultation (at the hospital or on the phone)
time frame: at inclusion and 6 months later
measure: Score on the cancer recurrence scale
time frame: at inclusion and 6 months later
arm group label: Post traumatic stress and anxiety evaluation
arm group type: Experimental
intervention type: Other
intervention name: Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later
description: The first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease).
arm group label: Post traumatic stress and anxiety evaluation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gwenaelle GRAVIS, MD
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic