<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/NCT04422730</url>
  </required_header>
  <id_info>
    <org_study_id>COSI-PC-IPC 2019-022</org_study_id>
    <nct_id>NCT04422730</nct_id>
  </id_info>
  <brief_title>Evolution of Body Connection After Surgery</brief_title>
  <official_title>Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of psychological impact of patients after pancreatectomy because of cancer&#xD;
      diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3&#xD;
      control groups will be used to compare de psychological impact.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>comparaison of Scale of Body Connection score between 4 groups</measure>
    <time_frame>12 months</time_frame>
    <description>score from 0 to 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comparaison of psychological interview between 4 groups</measure>
    <time_frame>12 months</time_frame>
    <description>measured by an psychologist interpretation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comparaison of Hospital Anxiety and Dépression score between 4 groups</measure>
    <time_frame>12 months</time_frame>
    <description>score from 0 to 21</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comparaison of Test IES-R score between 4 groups</measure>
    <time_frame>12 months</time_frame>
    <description>score from 0 to100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comparaison of quality of life score between 4 groups</measure>
    <time_frame>12 months</time_frame>
    <description>score from 0 to 60</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Pancreas Cancer</condition>
  <arm_group>
    <arm_group_label>pancreatectomy in cancer patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pancreatectomy in non-cancer patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>mastectomy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute leukaemia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychological evaluation</intervention_name>
    <description>Patients will be answer to validated test about how they feel. Psychological interview is also possible depending on patients availability. The different answers will be compared between the four groups</description>
    <arm_group_label>Acute leukaemia</arm_group_label>
    <arm_group_label>mastectomy</arm_group_label>
    <arm_group_label>pancreatectomy in cancer patients</arm_group_label>
    <arm_group_label>pancreatectomy in non-cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult people males and females&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is older than 18 years old&#xD;
&#xD;
          -  With a good understanding and practice of the French language&#xD;
&#xD;
          -  And depending on the group, experimental or control, presenting:&#xD;
&#xD;
               -  pancreatic cancer expected to be treated with pancreatectomy or planned to be&#xD;
                  treated with pancreatectomy excluding cancer or breast cancer scheduled to be&#xD;
                  treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).&#xD;
&#xD;
          -  No patient's opposition to the information provided&#xD;
&#xD;
          -  Affiliated to the social security plan or beneficiary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other medical or psychiatric condition,&#xD;
&#xD;
          -  Level of cognitive efficiency incompatible with response to questions about himself,&#xD;
&#xD;
          -  A person in an emergency situation, a person under legal protection or unable to&#xD;
             express the non opposition to their participation to research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Thérèse AURRAN, Dr</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>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 2, 2019</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</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>Pancreatic 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/NCT04422730
org study id: COSI-PC-IPC 2019-022
nct id: NCT04422730
lead sponsor: 
has dmc: No
Evaluation of psychological impact of patients after pancreatectomy because of cancer
      diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3
      control groups will be used to compare de psychological impact.
observational model: Case-Control
time perspective: Prospective
measure: comparaison of Scale of Body Connection score between 4 groups
time frame: 12 months
description: score from 0 to 5
measure: comparaison of psychological interview between 4 groups
time frame: 12 months
description: measured by an psychologist interpretation
measure: comparaison of Hospital Anxiety and Dépression score between 4 groups
time frame: 12 months
description: score from 0 to 21
measure: comparaison of Test IES-R score between 4 groups
time frame: 12 months
description: score from 0 to100
measure: comparaison of quality of life score between 4 groups
time frame: 12 months
description: score from 0 to 60
arm group label: pancreatectomy in cancer patients
arm group label: pancreatectomy in non-cancer patients
arm group label: mastectomy
arm group label: Acute leukaemia
intervention type: Behavioral
intervention name: Psychological evaluation
description: Patients will be answer to validated test about how they feel. Psychological interview is also possible depending on patients availability. The different answers will be compared between the four groups
arm group label: Acute leukaemia
arm group label: mastectomy
arm group label: pancreatectomy in cancer patients
arm group label: pancreatectomy in non-cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Thérèse AURRAN, Dr
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
facility: 
country: France
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No