<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/NCT03241251</url>
  </required_header>
  <id_info>
    <org_study_id>S60600</org_study_id>
    <nct_id>NCT03241251</nct_id>
  </id_info>
  <brief_title>Screening for Psychosocial Risk in Flemish Families of a Child With Cancer</brief_title>
  <official_title>Screening for Psychosocial Risk in Flemish Families of a Child With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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 Psychosocial Assessment Tool (PAT) is an international used instrument for the screening&#xD;
      for psychosocial risk factors in families of a child with cancer. This study want to&#xD;
      investigate the validation and evaluation of the clinical value of the Flemish translation of&#xD;
      the psychosocial assessment tool&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychosocial support of children having a diagnosis of cancer and their families is a crucial&#xD;
      aspect of a qualitative treatment. Assessment of psychosocial needs is a first step in order&#xD;
      to provide better and preventive psychosocial support. In Flanders, no instrument for&#xD;
      screening of psychosocial needs is available. The Psychosocial Assessment Tool (PAT) is an&#xD;
      international used instrument for the screening for psychosocial risk factors in families of&#xD;
      a child with cancer. This study want to investigate the validation and evaluation of the&#xD;
      clinical value of the Flemish translation of the PAT. Two large Flemish pediatric oncology&#xD;
      centers will participate: University hospital Ghent (UZGent) and the University hospital in&#xD;
      Leuven (UZLeuven). During a time period of 2.5 years families in which a child received a new&#xD;
      diagnosis of a pediatric cancer will be invited to participate in this study. All subscales&#xD;
      of the PAT will be validated by the use of standardized parent questionnaires measuring&#xD;
      similar constructs: Inventory Social Reliance, Strengths and Difficulties Questionnaire,&#xD;
      Hospital Anxiety and Depression Scale, Parenting Stress Index-short version and illness&#xD;
      cognitions questionnaire, parent version. The usability of the PAT will be evaluated with the&#xD;
      PAT-Netherlands Usability questionnaire. The clinical value will be evaluated by comparing&#xD;
      the clinical judgment of psychosocial risk by the psychosocial team members of both centers&#xD;
      with the scores on the PAT.&#xD;
&#xD;
      The proposed project is an important step to ameliorate psychosocial support in families with&#xD;
      a child with a diagnosis of cancer in Flemish pediatric oncological centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>validation of PAT questionnaire</measure>
    <time_frame>baseline assessment at diagnosis</time_frame>
    <description>The PAT validation will be performed by correlating PAT scores with validated questionnaires measuring similar constructs as the PAT. These questionnaires are Inventory social reliance, strengths and difficulties questionnaire , hospital anxiety and depression scale, parenting stress index -short version and illness cognition questionnaire parent version.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical value of questionnaire</measure>
    <time_frame>baseline assessment at diagnosis</time_frame>
    <description>a risk estimation of psychosocial risk by psychosocial team after diagnosis, but blinded to PAT scores, will be compared with PAT scores</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Pediatric Cancer</condition>
  <arm_group>
    <arm_group_label>parents children pediatric cancer</arm_group_label>
    <description>Screening questionnaire psychosocial risk factors</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Questionnaire of psychosocial risk factors</description>
    <arm_group_label>parents children pediatric cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        parents of all children and adolescents from 0-18 years that are diagnosed with cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents of all children and adolescents from 0-18 years that are diagnosed with cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no knowledge of Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jurgen Lemiere, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jurgen Lemiere, PhD</last_name>
    <phone>0032 16 34 22 35</phone>
    <email>jurgen.lemiere@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Trui Vercruysse, MSc</last_name>
    <phone>0032 16 34 02 66</phone>
    <email>trui.vercruysse@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jurgen Lemiere, PhD</last_name>
      <phone>+32 16 34 22</phone>
      <phone_ext>35</phone_ext>
      <email>jurgen.lemiere@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychosocial risk</keyword>
  <!-- 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/NCT03241251
org study id: S60600
nct id: NCT03241251
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening
      for psychosocial risk factors in families of a child with cancer. This study want to
      investigate the validation and evaluation of the clinical value of the Flemish translation of
      the psychosocial assessment tool
Psychosocial support of children having a diagnosis of cancer and their families is a crucial
      aspect of a qualitative treatment. Assessment of psychosocial needs is a first step in order
      to provide better and preventive psychosocial support. In Flanders, no instrument for
      screening of psychosocial needs is available. The Psychosocial Assessment Tool (PAT) is an
      international used instrument for the screening for psychosocial risk factors in families of
      a child with cancer. This study want to investigate the validation and evaluation of the
      clinical value of the Flemish translation of the PAT. Two large Flemish pediatric oncology
      centers will participate: University hospital Ghent (UZGent) and the University hospital in
      Leuven (UZLeuven). During a time period of 2.5 years families in which a child received a new
      diagnosis of a pediatric cancer will be invited to participate in this study. All subscales
      of the PAT will be validated by the use of standardized parent questionnaires measuring
      similar constructs: Inventory Social Reliance, Strengths and Difficulties Questionnaire,
      Hospital Anxiety and Depression Scale, Parenting Stress Index-short version and illness
      cognitions questionnaire, parent version. The usability of the PAT will be evaluated with the
      PAT-Netherlands Usability questionnaire. The clinical value will be evaluated by comparing
      the clinical judgment of psychosocial risk by the psychosocial team members of both centers
      with the scores on the PAT.

      The proposed project is an important step to ameliorate psychosocial support in families with
      a child with a diagnosis of cancer in Flemish pediatric oncological centers.
observational model: Cohort
time perspective: Prospective
measure: validation of PAT questionnaire
time frame: baseline assessment at diagnosis
description: The PAT validation will be performed by correlating PAT scores with validated questionnaires measuring similar constructs as the PAT. These questionnaires are Inventory social reliance, strengths and difficulties questionnaire , hospital anxiety and depression scale, parenting stress index -short version and illness cognition questionnaire parent version.
measure: clinical value of questionnaire
time frame: baseline assessment at diagnosis
description: a risk estimation of psychosocial risk by psychosocial team after diagnosis, but blinded to PAT scores, will be compared with PAT scores
arm group label: parents children pediatric cancer
description: Screening questionnaire psychosocial risk factors
intervention type: Other
intervention name: questionnaire
description: Questionnaire of psychosocial risk factors
arm group label: parents children pediatric cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Jurgen Lemiere, PhD
role: Study Director
affiliation: UZ Leuven
last name: Jurgen Lemiere, PhD
phone: 0032 16 34 22 35
email: jurgen.lemiere@uzleuven.be
last name: Trui Vercruysse, MSc
phone: 0032 16 34 02 66
email: trui.vercruysse@uzleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor