<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/NCT01724333</url>
  </required_header>
  <id_info>
    <org_study_id>2012/1390REK</org_study_id>
    <secondary_id>EORTC-SG2012</secondary_id>
    <nct_id>NCT01724333</nct_id>
  </id_info>
  <brief_title>International Validation of the QLQ-OH17 for Oral Health</brief_title>
  <acronym>QLQ-OH17</acronym>
  <official_title>International Validation and Testing of a Supplementary Questionnaire Module for Assessment of Oral and Dental Health in Cancer; the QLQ-OH17</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of oral and dental problems is seldom routine in clinical oncology, despite the&#xD;
      potential negative impact of these problems on nutritional status, social function and&#xD;
      quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues&#xD;
      to improve symptom management has been requested. The present study will be conducted on&#xD;
      behalf of and with support from the European Organisation for Research and Treatment of&#xD;
      Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step,&#xD;
      in the development of an international, symptom specific questionnaire module, focusing on&#xD;
      oral and dental problems in relation to cancer and its treatment. Phase I-III of this&#xD;
      stepwise development process was conducted from 2008 to 2011, as an international&#xD;
      collaboration and conducted according to the guidelines for module development set forth by&#xD;
      the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field&#xD;
      testing and validation study as described in this project description.&#xD;
&#xD;
      The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item&#xD;
      scales (pain/discomfort, xerostomia, eating and information) and three single items related&#xD;
      to use of dentures and future worries. The aim of the present study is to conduct phase IV;&#xD;
      an international field study to confirm the psychometric properties of the QLQ-OH17&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EORTC guidelines will be strictly followed also in phase IV of the module development.&#xD;
      Eligible patients will be contacted by the local study coordinator or a study nurse and&#xD;
      informed about the study. After having provided written informed consent, they will be&#xD;
      presented with the following two questionnaires for self-report of general symptoms, specific&#xD;
      dental and oral symptoms, and quality of life issues; the EORTC QLQ-C30 and the QLQ-OH17. In&#xD;
      addition to these two, a short debriefing interview will be conducted by study coordinator /&#xD;
      study nurse for assessment of feasibility and patients' opinion about the questionnaires.&#xD;
&#xD;
      The case report form (CRF) on medical and demographic data will be completed by the study&#xD;
      coordinator / study nurse before or after the patients have completed their part.&#xD;
&#xD;
      A subset of the patients will be assessed twice, as examination of test - retest reliability&#xD;
      is important in phase IV of the development process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oral morbidity</measure>
    <time_frame>Up to two years</time_frame>
    <description>The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to two years</time_frame>
    <description>The questionnaire module that is subject to testing of psychometric properties, will be used together with a well-validated quality of life questionnaire, to investigate if oral morbidity affects overall quality of life</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">585</enrollment>
  <condition>Quality of Life</condition>
  <condition>Adverse Effects</condition>
  <condition>Late Effects</condition>
  <condition>Cancer</condition>
  <condition>Xerostomia</condition>
  <arm_group>
    <arm_group_label>Group 1- in active treatment</arm_group_label>
    <description>Questionnaires only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - 2-6 months post-treatment</arm_group_label>
    <description>Questionnaires only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 - 6 mos-3yrs post-treatment</arm_group_label>
    <description>Questionnaires only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 - Palliative treatment</arm_group_label>
    <description>Questionnaires only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5 - Referred to dentist/oral team</arm_group_label>
    <description>Questionnaires only</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        An international, cross-cultural sample of cancer patients with different diagnoses in&#xD;
        different phases of treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H&amp;N&#xD;
             cancer&#xD;
&#xD;
          -  Sufficient language ability to understand and complete the questionnaires without&#xD;
             assistance&#xD;
&#xD;
          -  No obvious cognitive impairments, as judged by the study coordinator upon inclusion&#xD;
&#xD;
          -  Age 18 years or above&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
          -  No participation in another trial or study possibly interfering with the present study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients being diagnosed with basal cell carcinoma&#xD;
&#xD;
          -  Patients who have been included in Phase I-III of the module development&#xD;
&#xD;
          -  Patients who are in the terminal phase of cancer&#xD;
&#xD;
          -  Patients who are unable to participate in the interviews do to obvious cognitive&#xD;
             impairment, psychological disturbance or language problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne J Hjermstad, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Metz</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Gutenberg University Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv University</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori &quot;Fondazione G. Pascale&quot;- IRCCS,</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Centre for Dentistry Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Dietl Specialistic Hospital,</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jagiellonian University Medical College</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Leeds</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <reference>
    <citation>Hjermstad MJ, Bergenmar M, Bjordal K, Fisher SE, Hofmeister D, Montel S, Nicolatou-Galitis O, Pinto M, Raber-Durlacher J, Singer S, Tomaszewska IM, Tomaszewski KA, Verdonck-de Leeuw I, Yarom N, Winstanley JB, Herlofson BB; EORTC QoL Group. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer. 2016 Sep;24(9):3915-24. doi: 10.1007/s00520-016-3216-0. Epub 2016 Apr 25.</citation>
    <PMID>27113466</PMID>
  </reference>
  <results_reference>
    <citation>Hjermstad MJ, Bergenmar M, Fisher SE, Montel S, Nicolatou-Galitis O, Raber-Durlacher J, Singer S, Verdonck-de Leeuw I, Weis J, Yarom N, Herlofson BB. The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients. Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Epub 2012 May 8.</citation>
    <PMID>22572480</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>April 28, 2016</last_update_submitted>
  <last_update_submitted_qc>April 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EORTC QLQ-C30</keyword>
  <keyword>Oral health</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Patient reported</keyword>
  <keyword>outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Phase III and Phase IV reports approved by the EORTC Quality of Life Group Executive Committee. First publication in Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Second publication accepted for publication in Supp Care Cancer, April 2016</ipd_description>
  </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/NCT01724333
org study id: 2012/1390REK
secondary id: EORTC-SG2012
nct id: NCT01724333
lead sponsor: 
collaborator: 
has dmc: No
Assessment of oral and dental problems is seldom routine in clinical oncology, despite the
      potential negative impact of these problems on nutritional status, social function and
      quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues
      to improve symptom management has been requested. The present study will be conducted on
      behalf of and with support from the European Organisation for Research and Treatment of
      Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step,
      in the development of an international, symptom specific questionnaire module, focusing on
      oral and dental problems in relation to cancer and its treatment. Phase I-III of this
      stepwise development process was conducted from 2008 to 2011, as an international
      collaboration and conducted according to the guidelines for module development set forth by
      the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field
      testing and validation study as described in this project description.

      The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item
      scales (pain/discomfort, xerostomia, eating and information) and three single items related
      to use of dentures and future worries. The aim of the present study is to conduct phase IV;
      an international field study to confirm the psychometric properties of the QLQ-OH17
The EORTC guidelines will be strictly followed also in phase IV of the module development.
      Eligible patients will be contacted by the local study coordinator or a study nurse and
      informed about the study. After having provided written informed consent, they will be
      presented with the following two questionnaires for self-report of general symptoms, specific
      dental and oral symptoms, and quality of life issues; the EORTC QLQ-C30 and the QLQ-OH17. In
      addition to these two, a short debriefing interview will be conducted by study coordinator /
      study nurse for assessment of feasibility and patients' opinion about the questionnaires.

      The case report form (CRF) on medical and demographic data will be completed by the study
      coordinator / study nurse before or after the patients have completed their part.

      A subset of the patients will be assessed twice, as examination of test - retest reliability
      is important in phase IV of the development process.
observational model: Cohort
time perspective: Cross-Sectional
measure: Oral morbidity
time frame: Up to two years
description: The study aims to validate a questionnaire for assessment of oral morbidity, oral health , and quality of life in relation to cancer treatment. Specific outcomes are prevalence of patients with moderate to severe oral morbidity due to cancer treatment (mucositis,stomatitis, taste change, decayed /loose teeth, osteoradionecrosis, ulcers), to investigate if the severity varies with certain background variables , for example, diagnostic group, age, sex, stage of disease, type of treatment, and to investigate the discriminant validity, reliability and responsiveness of the specific items in patient subgroups
measure: Quality of life
time frame: Up to two years
description: The questionnaire module that is subject to testing of psychometric properties, will be used together with a well-validated quality of life questionnaire, to investigate if oral morbidity affects overall quality of life
arm group label: Group 1- in active treatment
description: Questionnaires only
arm group label: Group 2 - 2-6 months post-treatment
description: Questionnaires only
arm group label: Group 3 - 6 mos-3yrs post-treatment
description: Questionnaires only
arm group label: Group 4 - Palliative treatment
description: Questionnaires only
arm group label: Group 5 - Referred to dentist/oral team
description: Questionnaires only
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marianne J Hjermstad, PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Netherlands
country: Norway
country: Poland
country: Sweden
country: United Kingdom
country: Australia
citation: Hjermstad MJ, Bergenmar M, Bjordal K, Fisher SE, Hofmeister D, Montel S, Nicolatou-Galitis O, Pinto M, Raber-Durlacher J, Singer S, Tomaszewska IM, Tomaszewski KA, Verdonck-de Leeuw I, Yarom N, Winstanley JB, Herlofson BB; EORTC QoL Group. International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ-OH15. Support Care Cancer. 2016 Sep;24(9):3915-24. doi: 10.1007/s00520-016-3216-0. Epub 2016 Apr 25.
PMID: 27113466
citation: Hjermstad MJ, Bergenmar M, Fisher SE, Montel S, Nicolatou-Galitis O, Raber-Durlacher J, Singer S, Verdonck-de Leeuw I, Weis J, Yarom N, Herlofson BB. The EORTC QLQ-OH17: a supplementary module to the EORTC QLQ-C30 for assessment of oral health and quality of life in cancer patients. Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Epub 2012 May 8.
PMID: 22572480
responsible party type: Sponsor
mesh term: Xerostomia
sharing ipd: Yes
ipd description: Phase III and Phase IV reports approved by the EORTC Quality of Life Group Executive Committee. First publication in Eur J Cancer. 2012 Sep;48(14):2203-11. doi: 10.1016/j.ejca.2012.04.003. Second publication accepted for publication in Supp Care Cancer, April 2016