<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/NCT03240029</url>
  </required_header>
  <id_info>
    <org_study_id>2009-A01379-48</org_study_id>
    <nct_id>NCT03240029</nct_id>
  </id_info>
  <brief_title>Life Quality of Children in Cancer Remission During School Reintegration</brief_title>
  <acronym>QdV leucémie</acronym>
  <official_title>Life Quality of Children in Cancer Remission During School Reintegration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Few data about the evaluation of consequences of past life with cancer on life quality of&#xD;
      children in school reintegration are available in literature. Nevertheless, some of these&#xD;
      studies show that the reintegration impairs life quality of these children (school&#xD;
      difficulties, conflictual relations with peers…). The hypothesis is that children with past&#xD;
      life with cancer have more chances to have school integration difficulties with a consequent&#xD;
      life quality degradation compared to healthy children.&#xD;
&#xD;
      The main objective of this project is to study the relation between the satisfaction of&#xD;
      school reintegration of children in cancer remission and the evolution of life quality in the&#xD;
      medium term (after getting back to school). More exactly, it is the question if the&#xD;
      satisfaction of school reintegration influences life goals and priorities of these children.&#xD;
&#xD;
      The secondary objective is to study the role of psychological status of these children&#xD;
      (anxiety, depressive symptoms) on satisfaction-life quality relation.&#xD;
&#xD;
      A group of children with cancer history sent to ordinary school is compared to a control&#xD;
      group of children sent to school in the same conditions (sex and age matched). Data are&#xD;
      collected with questionnaires some months to several years after school reintegration and&#xD;
      same questionnaires 1 year later.&#xD;
&#xD;
      If the study hypothesis is confirmed, this study will show the necessity of a long term&#xD;
      follow up of children in cancer remission and not only medical care, but also psychological&#xD;
      and social care, in order to support a better school reintegration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2010</start_date>
  <completion_date type="Actual">September 11, 2013</completion_date>
  <primary_completion_date type="Actual">September 11, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Life quality of children according to satisfaction of school reintegration</measure>
    <time_frame>baseline</time_frame>
    <description>Evaluated through questionnaires</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Life quality of children according to satisfaction of school reintegration</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated through questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>baseline</time_frame>
    <description>Evaluated through questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated through questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>baseline</time_frame>
    <description>Evaluated through questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated through questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cancer Remission</condition>
  <arm_group>
    <arm_group_label>Children in cancer remission</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control children</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children (not in cancer remission) sent to ordinary schools (age and sex matched): primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)</description>
    <arm_group_label>Children in cancer remission</arm_group_label>
    <arm_group_label>Control children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Group of children in cancer remission:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of both sexes in cancer remission (leukemia, with or without transplant and&#xD;
             solid tumors), aged 8 to 12&#xD;
&#xD;
          -  Stop of treatment since at least 6 months&#xD;
&#xD;
          -  Back to school since some months to several years&#xD;
&#xD;
          -  Signed consent of parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychic difficulties&#xD;
&#xD;
          -  Specialized education&#xD;
&#xD;
        Group of control children:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - Signed consent of parents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal Chastagner, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatric Hematology/Oncology, CHRU de Nancy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabienne Lemétayer</last_name>
    <role>Study Chair</role>
    <affiliation>University Paul Verlaine - Metz / Human Science and art department - Health psychology team</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU de Nancy</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>life quality</keyword>
  <keyword>school reintegration</keyword>
  <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/NCT03240029
org study id: 2009-A01379-48
nct id: NCT03240029
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Few data about the evaluation of consequences of past life with cancer on life quality of
      children in school reintegration are available in literature. Nevertheless, some of these
      studies show that the reintegration impairs life quality of these children (school
      difficulties, conflictual relations with peers…). The hypothesis is that children with past
      life with cancer have more chances to have school integration difficulties with a consequent
      life quality degradation compared to healthy children.

      The main objective of this project is to study the relation between the satisfaction of
      school reintegration of children in cancer remission and the evolution of life quality in the
      medium term (after getting back to school). More exactly, it is the question if the
      satisfaction of school reintegration influences life goals and priorities of these children.

      The secondary objective is to study the role of psychological status of these children
      (anxiety, depressive symptoms) on satisfaction-life quality relation.

      A group of children with cancer history sent to ordinary school is compared to a control
      group of children sent to school in the same conditions (sex and age matched). Data are
      collected with questionnaires some months to several years after school reintegration and
      same questionnaires 1 year later.

      If the study hypothesis is confirmed, this study will show the necessity of a long term
      follow up of children in cancer remission and not only medical care, but also psychological
      and social care, in order to support a better school reintegration.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Life quality of children according to satisfaction of school reintegration
time frame: baseline
description: Evaluated through questionnaires
measure: Life quality of children according to satisfaction of school reintegration
time frame: 1 year
description: Evaluated through questionnaires
measure: Anxiety
time frame: baseline
description: Evaluated through questionnaires
measure: Anxiety
time frame: 1 year
description: Evaluated through questionnaires
measure: Depressive symptoms
time frame: baseline
description: Evaluated through questionnaires
measure: Depressive symptoms
time frame: 1 year
description: Evaluated through questionnaires
arm group label: Children in cancer remission
arm group type: Experimental
description: Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.
arm group label: Control children
arm group type: Other
description: Children (not in cancer remission) sent to ordinary schools (age and sex matched): primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.
intervention type: Other
intervention name: Questionnaires
description: SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
arm group label: Children in cancer remission
arm group label: Control children
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal Chastagner, Pr
role: Principal Investigator
affiliation: Pediatric Hematology/Oncology, CHRU de Nancy
last name: Fabienne Lemétayer
role: Study Chair
affiliation: University Paul Verlaine - Metz / Human Science and art department - Health psychology team
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No