xml: <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/NCT05968027</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230641</org_study_id>
      <nct_id>NCT05968027</nct_id>
    </id_info>
    <brief_title>Improving Care Pathway Using Simplified Digital Tools for Oncology Patients: a Multicenter &quot;Before-and-after&quot; Study</brief_title>
    <acronym>ONCONECTSAFE</acronym>
    <official_title>Improving Care Pathway Using Simplified Digital Tools for Oncology Patients: a Multicenter &quot;Before-and-after&quot; Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nouveal</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Developments in the healthcare sector in general, and in oncology in particular, mean that&#xD;
        patients are increasingly autonomous. Outpatient treatment raises the issue of home&#xD;
        monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of&#xD;
        telemedicine. Several programmes have been set up in the medical oncology department at&#xD;
        Hôpital Mondor, to make patient care more secure and improve the management of undesirable&#xD;
        effects of treatment for patients undergoing intravenous (I.V.) chemotherapy or oral&#xD;
        anti-cancer treatments.&#xD;
  &#xD;
        The preliminary study on the use of the digital solution Onco'nect demonstrated the&#xD;
        feasibility of using a dematerialised tool for real-time monitoring and management of&#xD;
        chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment. The&#xD;
        tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic.&#xD;
        Once it had been configured, Onco'nect was deployed to all institution's hospital groups to&#xD;
        ensure that infected patients could remain at home, and that patients hospitalised with&#xD;
        symptomatic COVID infection could return home.&#xD;
  &#xD;
        Hypothesis: The digital solution Onco'nect would improve patient compliance and could reduce&#xD;
        the occurrence and improve the management of unexpected adverse events.&#xD;
  &#xD;
        Primary objective:&#xD;
  &#xD;
        In terms of clinical evaluation, the primary objective is to assess the effect of using the&#xD;
        Onco'nect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6&#xD;
        months follow-up of unexpected and unwanted chemo-induced adverse events.&#xD;
  &#xD;
        The solution is already on the market and has been integrated (or is in the process of being&#xD;
        integrated) into the care systems of the participating AP-HP establishments. The aim of the&#xD;
        project is to evaluate its use in routine care and measure the occurrence and management of&#xD;
        unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer.&#xD;
  &#xD;
        This observational study of care pathway, using retrospective data, aims to include 480&#xD;
        patients in a 18 months period.&#xD;
  &#xD;
        Three periods of interest will be considered in this before-and-after study&#xD;
  &#xD;
          -  Onco'nect pre-deployment (12 months): period covering the year prior to the actual&#xD;
             implementation of the solution in each centre; patients receiving I.V. chemotherapy&#xD;
             during the first 6 months of the period will be included, in order to assess follow-up&#xD;
             at 6 months.&#xD;
  &#xD;
          -  Onco'nect deployment: this period corresponds to the implementation of the solution in&#xD;
             the centre's care pathway. Deployment includes interoperability with other operating&#xD;
             systems and setting up the collection interfaces for the user.&#xD;
  &#xD;
          -  Post-deployment (12 months): period covering the year following the implementation of&#xD;
             the solution within the centre (installation, interoperability and configuration&#xD;
             validated); patients receiving I.V. chemotherapy during the first 6 months of the period&#xD;
             will be included, in order to be able to evaluate the 6-month follow-up.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2, 2024</start_date>
    <completion_date type="Anticipated">July 2, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>adverse events</measure>
      <time_frame>during a 6 months follow-up period starting after chemotherapy injection</time_frame>
      <description>presence of one or more unexpected and undesirable chemo-induced adverse events at 6 months' follow-up after the start of chemotherapy (use of unscheduled hospitalisation, consultation/admission to the emergency department, grade 3 and 4 toxicities according to version 5 of the CTCAE, changes in chemotherapy administration schedules, such as last-minute cancellations, changes in dose and frequency of treatment administration).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Oncology</condition>
    <condition>Adverse Event</condition>
    <condition>Numeric Application</condition>
    <condition>Care Telemonitoring</condition>
    <condition>Compliance, Treatment</condition>
    <condition>Patient Reported Outcome (PRO)</condition>
    <arm_group>
      <arm_group_label>Onco'nect pre-deployment</arm_group_label>
      <description>- Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess the 6-month follow-up.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Onco'nect post-deployment</arm_group_label>
      <description>-Onco'nect post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and parameterisation validated); patients with I.V. chemotherapy implemented during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nouveal numeric application &quot;Onco'nect&quot;</intervention_name>
      <description>A remote monitoring application, Onco'nect® (smartphone /tablet /PC), in partnership with the company Nouveal facilitates communication between patients undergoing Intra Vascular (IV) chemotherapy and the care team. A questionnaire before and after each session can be used to alert the oncology department and adapt patient management.</description>
      <arm_group_label>Onco'nect post-deployment</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated with IV chemotherapy and monitored in the medical oncology departments of&#xD;
          participating centres (AP-HP): CHU Henri Mondor Créteil (HMN), CHU Pitié Salpêtrière Paris&#xD;
          (PSL), CHU Bichat Paris (BCT), CHU Saint Antoine (SAT) and CHU Georges Pompidou (HEGP).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Age &gt;=18 years&#xD;
  &#xD;
            -  Initiation of I.V. chemotherapy for solid cancer of any location or metastatic status:&#xD;
  &#xD;
            -  Either over a period of 12 months before Onco'nect is deployed, covering the year&#xD;
               preceding the actual implementation of the solution in each centre.&#xD;
  &#xD;
            -  Or over a period of 12 months post-deployment of Onco'nect, covering the year&#xD;
               following the implementation of the solution within the centre.&#xD;
  &#xD;
            -  Non-opposition to the study and to the processing of their medical data.&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Any known difficulty in understanding or reading French that might invalidate the&#xD;
               relevance of applying questionnaires&#xD;
  &#xD;
            -  Known cognitive or psychiatric disorder preventing the protocol from being carried out&#xD;
  &#xD;
            -  Patient under legal protection&#xD;
  &#xD;
            -  Patient included in the article 51 programme&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Christophe TOURNIGAND, MD-PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sophie THÉVENIN</last_name>
      <phone>(0)1 44 84 17 63</phone>
      <phone_ext>0033</phone_ext>
      <email>sophie.thevenin@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pierre-André NATELLA, PharmD</last_name>
      <phone>(0)1 49 81 37 98</phone>
      <phone_ext>0033</phone_ext>
      <email>pierre.natella@aphp.fr</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>AP-HP, as sponsor, is the owner of the data and no use or transmission to a third party may be made without its prior agreement.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968027
  org study id: APHP230641
  nct id: NCT05968027
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Developments in the healthcare sector in general, and in oncology in particular, mean that
        patients are increasingly autonomous. Outpatient treatment raises the issue of home
        monitoring. One of the solutions proposed by the 2014-2019 Cancer Plan is the development of
        telemedicine. Several programmes have been set up in the medical oncology department at
        Hôpital Mondor, to make patient care more secure and improve the management of undesirable
        effects of treatment for patients undergoing intravenous (I.V.) chemotherapy or oral
        anti-cancer treatments.
  
        The preliminary study on the use of the digital solution Onco'nect demonstrated the
        feasibility of using a dematerialised tool for real-time monitoring and management of
        chemotherapy-induced adverse events in cancer patients undergoing outpatient treatment. The
        tool was used to help AP-HP institution deal with the crisis linked to the COVID epidemic.
        Once it had been configured, Onco'nect was deployed to all institution's hospital groups to
        ensure that infected patients could remain at home, and that patients hospitalised with
        symptomatic COVID infection could return home.
  
        Hypothesis: The digital solution Onco'nect would improve patient compliance and could reduce
        the occurrence and improve the management of unexpected adverse events.
  
        Primary objective:
  
        In terms of clinical evaluation, the primary objective is to assess the effect of using the
        Onco'nect solution for ambulatory oncology follow-up on reducing the rate of occurrence at 6
        months follow-up of unexpected and unwanted chemo-induced adverse events.
  
        The solution is already on the market and has been integrated (or is in the process of being
        integrated) into the care systems of the participating AP-HP establishments. The aim of the
        project is to evaluate its use in routine care and measure the occurrence and management of
        unexpected and unwanted chemo-induced adverse events in outpatients treated for cancer.
  
        This observational study of care pathway, using retrospective data, aims to include 480
        patients in a 18 months period.
  
        Three periods of interest will be considered in this before-and-after study
  
          -  Onco'nect pre-deployment (12 months): period covering the year prior to the actual
             implementation of the solution in each centre; patients receiving I.V. chemotherapy
             during the first 6 months of the period will be included, in order to assess follow-up
             at 6 months.
  
          -  Onco'nect deployment: this period corresponds to the implementation of the solution in
             the centre's care pathway. Deployment includes interoperability with other operating
             systems and setting up the collection interfaces for the user.
  
          -  Post-deployment (12 months): period covering the year following the implementation of
             the solution within the centre (installation, interoperability and configuration
             validated); patients receiving I.V. chemotherapy during the first 6 months of the period
             will be included, in order to be able to evaluate the 6-month follow-up.
  observational model: Case-Control
  time perspective: Retrospective
  measure: adverse events
  time frame: during a 6 months follow-up period starting after chemotherapy injection
  description: presence of one or more unexpected and undesirable chemo-induced adverse events at 6 months' follow-up after the start of chemotherapy (use of unscheduled hospitalisation, consultation/admission to the emergency department, grade 3 and 4 toxicities according to version 5 of the CTCAE, changes in chemotherapy administration schedules, such as last-minute cancellations, changes in dose and frequency of treatment administration).
  arm group label: Onco'nect pre-deployment
  description: - Onco'nect pre-deployment (12 months): period covering the year prior to the actual implementation of the solution in each centre; patients receiving I.V. chemotherapy during the first 6 months of the period will be included, in order to assess the 6-month follow-up.
  arm group label: Onco'nect post-deployment
  description: -Onco'nect post-deployment (12 months): period covering the year following the implementation of the solution within the centre (installation, interoperability and parameterisation validated); patients with I.V. chemotherapy implemented during the first 6 months of the period will be included, in order to be able to evaluate the 6-month follow-up.
  intervention type: Other
  intervention name: Nouveal numeric application "Onco'nect"
  description: A remote monitoring application, Onco'nect® (smartphone /tablet /PC), in partnership with the company Nouveal facilitates communication between patients undergoing Intra Vascular (IV) chemotherapy and the care team. A questionnaire before and after each session can be used to alert the oncology department and adapt patient management.
  arm group label: Onco'nect post-deployment
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Christophe TOURNIGAND, MD-PhD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Sophie THÉVENIN
  phone: (0)1 44 84 17 63
  phone ext: 0033
  email: sophie.thevenin@aphp.fr
  last name: Pierre-André NATELLA, PharmD
  phone: (0)1 49 81 37 98
  phone ext: 0033
  email: pierre.natella@aphp.fr
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No
  ipd description: AP-HP, as sponsor, is the owner of the data and no use or transmission to a third party may be made without its prior agreement.