<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/NCT04399863</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200113</org_study_id>
    <secondary_id>IDRCB: 2019-A03127-50</secondary_id>
    <nct_id>NCT04399863</nct_id>
  </id_info>
  <brief_title>ETOILE : A Feasibility Study in Pediatric Patient Education</brief_title>
  <acronym>ETOILE</acronym>
  <official_title>Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Feasibility study of a therapeutic education program for the patient and his carers, intended&#xD;
      for children suffering from acute lymphoblastic leukemia or having received an allograft of&#xD;
      hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital (&#xD;
      Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will&#xD;
      be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized,&#xD;
      mono-centric type. Feasibility is assessed on process criteria (adoption, reach&#xD;
      implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of&#xD;
      patients and their caregivers, before, after and at a distance from education. Patients'&#xD;
      anxiety levels will also be assessed before, after and at a distance from the program. The&#xD;
      level of health literacy will be assessed at the start of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 2, 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the ETOILE program</measure>
    <time_frame>6 months</time_frame>
    <description>number of patients which joined the programme compared to number of patients referred</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Leukemia, Lymphoblastic</condition>
  <arm_group>
    <arm_group_label>ETOILE therapeutic education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ETOILE therapeutic education</intervention_name>
    <description>ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.</description>
    <arm_group_label>ETOILE therapeutic education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Criteria relating to the population studied: child between 0 and 18 years old,&#xD;
             followed at Robert Debré hospital (Paris), by a doctor from the hematology and&#xD;
             immunology department&#xD;
&#xD;
               -  Of which the 2 holders of parental authority have been informed and have signed&#xD;
                  the consent&#xD;
&#xD;
               -  Having 1 or 2 caregivers available to accompany him during FTE sessions&#xD;
&#xD;
               -  1 to 2 of their adult caregivers will be eligible for the ETOILE program and will&#xD;
                  be included in the study after their consent.&#xD;
&#xD;
               -  Child with acute lymphoblastic leukemia, treated at Robert Debré Hospital&#xD;
                  (Paris), in the induction or consolidation phase&#xD;
&#xD;
               -  Child going to receive or having received an allograft of hematopoietic stem&#xD;
                  cells at the Robert Debré hospital (Paris)&#xD;
&#xD;
               -  Beneficiaries of a social security scheme or entitled to it,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child not mastering the French language,&#xD;
&#xD;
          -  Child with physical or cognitive disability to participate in the program,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie ROUPRET-SERZEC, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Robert Debre Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>therapeutic education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</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/NCT04399863
org study id: APHP200113
secondary id: IDRCB: 2019-A03127-50
nct id: NCT04399863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Feasibility study of a therapeutic education program for the patient and his carers, intended
      for children suffering from acute lymphoblastic leukemia or having received an allograft of
      hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital (
      Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will
      be assessed.
This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized,
      mono-centric type. Feasibility is assessed on process criteria (adoption, reach
      implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of
      patients and their caregivers, before, after and at a distance from education. Patients'
      anxiety levels will also be assessed before, after and at a distance from the program. The
      level of health literacy will be assessed at the start of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of the ETOILE program
time frame: 6 months
description: number of patients which joined the programme compared to number of patients referred
arm group label: ETOILE therapeutic education
arm group type: Experimental
description: ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.
intervention type: Behavioral
intervention name: ETOILE therapeutic education
description: ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.
arm group label: ETOILE therapeutic education
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Julie ROUPRET-SERZEC, PharmD
role: Principal Investigator
affiliation: APHP
facility: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
sharing ipd: No