<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/NCT04496375</url>
  </required_header>
  <id_info>
    <org_study_id>ADN-CO-IPC 2020-004</org_study_id>
    <nct_id>NCT04496375</nct_id>
  </id_info>
  <brief_title>An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application</brief_title>
  <acronym>ADN-CO</acronym>
  <official_title>An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application</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 aim of our study is to investigate the effect of providing patients access to their&#xD;
      electronic medical records Via the IPC Connect Application on their A Survey will be proposed&#xD;
      to all outpatients with a solid or hematologic malignancy who will attend an appointement at&#xD;
      Institut Paoli Calmettes clinic.&#xD;
&#xD;
      Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31&#xD;
      questions addressed to all patients, 17 questions will be specifically addressed to patients&#xD;
      using IPC connect application and 7 questions will be addressed to patients who do not use&#xD;
      the application.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 5, 2020</start_date>
  <completion_date type="Anticipated">December 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 5, 2020</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>Impact of Patients Access to Their Electronic Medical Records Via the IPC Connect Application on patients anxiety level</measure>
    <time_frame>1 day</time_frame>
    <description>Anxiety level will be measured by the Hospital Anxiety and Depression scale</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Institut Paoli Calmettes Outpatients</arm_group_label>
    <description>Patients with a solid tumor or an hematologic malignancy who will attend an appointement at IPC Outpatients clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Self-completed questionnaires</description>
    <arm_group_label>Institut Paoli Calmettes Outpatients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All outpatients with an solid tumor or an hematologic malignancy who will attend Institut&#xD;
        Paoli-Calmettes Outpatients clinic during 1 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman, age&gt; 18 Years&#xD;
&#xD;
          -  Solid tumor or hematologic malignancy&#xD;
&#xD;
          -  Patient attending an appointment at Institut Paoli Calmettes&#xD;
&#xD;
          -  Non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency, Vulnerable person or unable to provide informed consent&#xD;
&#xD;
          -  First appointment at Institut Paoli Calmettes&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Genre, MD</last_name>
    <phone>+33491223778</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electronic Medical Records</keyword>
  <keyword>Patients anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic 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/NCT04496375
org study id: ADN-CO-IPC 2020-004
nct id: NCT04496375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to investigate the effect of providing patients access to their
      electronic medical records Via the IPC Connect Application on their A Survey will be proposed
      to all outpatients with a solid or hematologic malignancy who will attend an appointement at
      Institut Paoli Calmettes clinic.

      Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31
      questions addressed to all patients, 17 questions will be specifically addressed to patients
      using IPC connect application and 7 questions will be addressed to patients who do not use
      the application.
observational model: Cohort
time perspective: Prospective
measure: Impact of Patients Access to Their Electronic Medical Records Via the IPC Connect Application on patients anxiety level
time frame: 1 day
description: Anxiety level will be measured by the Hospital Anxiety and Depression scale
arm group label: Institut Paoli Calmettes Outpatients
description: Patients with a solid tumor or an hematologic malignancy who will attend an appointement at IPC Outpatients clinic
intervention type: Other
intervention name: Survey
description: Self-completed questionnaires
arm group label: Institut Paoli Calmettes Outpatients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gwenaelle Gravis
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: Dominique Genre, MD
phone: +33491223778
email: drci.up@ipc.unicancer.fr
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
sharing ipd: No