<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/NCT02979678</url>
  </required_header>
  <id_info>
    <org_study_id>27-355</org_study_id>
    <nct_id>NCT02979678</nct_id>
  </id_info>
  <brief_title>European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire (QLQ) Breast Cancer Module Update</brief_title>
  <official_title>The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the&#xD;
      development of BR-23 published 1996 the standard therapy of breast cancer has changed. New&#xD;
      therapies brought new side effects and different impact on QoL (quality of life) are not&#xD;
      sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both&#xD;
      from clinical and scientific point of view.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Based on a systematic literature search a new issue list will be developed, containing&#xD;
           additional issues relevant for new treatment strategies. A total of 5-10 patients from&#xD;
           different countries (5-8) as well as health care professionals (5/country) will be&#xD;
           interviewed (Phase 1).&#xD;
&#xD;
        2. Operationalization of the issues into items; a provisional version of a the&#xD;
           questionnaire and a hypothetic scale structure will be established (Phase2).&#xD;
&#xD;
        3. The resulting provisional updated module will be tested with respect to understanding,&#xD;
           comprehensiveness and applicability (according to the EORTC Module Development&#xD;
           Guidelines). The items will be translated from English into other languages following a&#xD;
           standardized forward-backward procedure. Total aof 260 patients will be interviewed from&#xD;
           different cultural areas: Northern Europe, Central Europe, Southern Europe, Asia (Phase&#xD;
           3).&#xD;
&#xD;
        4. The module and its scale structure will be field-tested in a large, international group&#xD;
           of patients in order to determine its acceptability, reliability, validity,&#xD;
           responsiveness and crosscultural applicability .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 years, Patients under treatment are asked once to complete the questionnaire during 3 years</time_frame>
    <description>Patients under Treatment are asked to complete the questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breast cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The questionnaire should be updated with respect to wording, terminology.</description>
    <arm_group_label>Questionnaire</arm_group_label>
    <other_name>EORTC QLQ-Breast Cancer Module Update</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with early or metastatic breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with second malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vesna Bjelic-Radisic</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vesna Bjelic-Radisic</last_name>
    <phone>+43 316 385 80504</phone>
    <email>vesna.bjelic-radisic@medunigraz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brigitte Bliem</last_name>
    <phone>+43 316 385 81426</phone>
    <email>brigitte.bliem@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vesna Bjelic-Radisic, MD</last_name>
      <phone>+43 316 385 80504</phone>
      <email>vesna.bjelic-radisic@medunigraz.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Rijeka</name>
      <address>
        <city>Rijeka</city>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de Lorraine</name>
      <address>
        <city>Lorraine</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Medical Center Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto Nazionale Tumori Fondazione Pascale</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IOV Oncologico Veneto Padova</name>
      <address>
        <city>Padivarma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Netherlands Cancer Institute - NKI</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jagiellonian University Medical College Krakow</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oncology Department Hospital of Navarre</name>
      <address>
        <city>Navarra</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.</citation>
    <PMID>8874337</PMID>
  </results_reference>
  <results_reference>
    <citation>Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011</citation>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>October 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer, quality of life</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/NCT02979678
org study id: 27-355
nct id: NCT02979678
lead sponsor: 
has dmc: No
The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the
      development of BR-23 published 1996 the standard therapy of breast cancer has changed. New
      therapies brought new side effects and different impact on QoL (quality of life) are not
      sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both
      from clinical and scientific point of view.
1. Based on a systematic literature search a new issue list will be developed, containing
           additional issues relevant for new treatment strategies. A total of 5-10 patients from
           different countries (5-8) as well as health care professionals (5/country) will be
           interviewed (Phase 1).

        2. Operationalization of the issues into items; a provisional version of a the
           questionnaire and a hypothetic scale structure will be established (Phase2).

        3. The resulting provisional updated module will be tested with respect to understanding,
           comprehensiveness and applicability (according to the EORTC Module Development
           Guidelines). The items will be translated from English into other languages following a
           standardized forward-backward procedure. Total aof 260 patients will be interviewed from
           different cultural areas: Northern Europe, Central Europe, Southern Europe, Asia (Phase
           3).

        4. The module and its scale structure will be field-tested in a large, international group
           of patients in order to determine its acceptability, reliability, validity,
           responsiveness and crosscultural applicability .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Quality of life
time frame: 3 years, Patients under treatment are asked once to complete the questionnaire during 3 years
description: Patients under Treatment are asked to complete the questionnaire
arm group label: Questionnaire
arm group type: Experimental
description: Breast cancer
intervention type: Other
intervention name: Questionnaire
description: The questionnaire should be updated with respect to wording, terminology.
arm group label: Questionnaire
other name: EORTC QLQ-Breast Cancer Module Update
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vesna Bjelic-Radisic
role: Principal Investigator
affiliation: Medical University of Graz
last name: Vesna Bjelic-Radisic
phone: +43 316 385 80504
email: vesna.bjelic-radisic@medunigraz.at
last name: Brigitte Bliem
phone: +43 316 385 81426
email: brigitte.bliem@medunigraz.at
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Austria
country: Croatia
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Spain
citation: Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.
PMID: 8874337
citation: Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011
responsible party type: Sponsor
sharing ipd: No