xml: <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/NCT05989191</url>
    </required_header>
    <id_info>
      <org_study_id>IC 2019-07</org_study_id>
      <nct_id>NCT05989191</nct_id>
    </id_info>
    <brief_title>Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires</brief_title>
    <acronym>PATSAT</acronym>
    <official_title>An International Field Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Curie</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Curie</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 aim of this study is to validate the EORTC PATSAT-C33 and EORTC OUT-PATSAT7&#xD;
        questionnaires scale structure in a large international field study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patient satisfaction is now recognized as an important indicator of care quality. Measures of&#xD;
        patient satisfaction with care can facilitate monitoring initiatives for care improvement&#xD;
        over time. The EORTC Quality of Life Group has cross-culturally validated a stand-alone&#xD;
        in-patient satisfaction with cancer care questionnaire, the IN-PATSAT32. Advances in cancer&#xD;
        care delivery required further development of this questionnaire to assess patients'&#xD;
        perceived quality of the care received in outpatient cancer care settings. Phase I to III of&#xD;
        this process have been completed, resulting in the EORTC PATSAT-C33 satisfaction with cancer&#xD;
        care core questionnaire to assess cancer care delivery as a whole and the complementary EORTC&#xD;
        OUT-PATSAT7, a questionnaire for the specific outpatient care settings. These questionnaires&#xD;
        concern all patients treated for their cancer, in the assessed service, regardless of the&#xD;
        stage and type of cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2020</start_date>
    <completion_date type="Anticipated">July 13, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 13, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Validate the EORTC PATSAT-C33 questionnaire</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Validate the EORTC OUT-PATSAT7 questionnaire</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cross-cultural applicability and acceptability</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of estimates of cross-cultural applicability and acceptability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reliability including test-retest and internal consistency</measure>
      <time_frame>change between inclusion et week 2</time_frame>
      <description>Adequacy of estimates for Reliability including test-retest and internal consistency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Validity, including construct (known-group comparisons)</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of estimates of validity, including construct (known-group comparisons)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Convergent and divergent validity</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of estimates of convergent and divergent validity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Responsiveness to change</measure>
      <time_frame>change between inclusion et year 1</time_frame>
      <description>Adequacy of estimates of responsiveness to change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cross-cultural invariance of psychometric properties</measure>
      <time_frame>At inclusion</time_frame>
      <description>Adequacy of estimates of cross-cultural invariance of psychometric properties</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          patients with cancer care setting as outpatient, chemotherapy day clinic/consultation for&#xD;
          oral treatment, ambulatory radiotherapy or consultation for follow-up surveillance or&#xD;
          inpatients or surgery ward.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients regardless of cancer site or stage of disease (i.e. local, loco-regional,&#xD;
          metastatic, in remission) will be invited to participate if they meet the following&#xD;
          criteria:&#xD;
  &#xD;
            1. Diagnosis of cancer confirmed histologically.&#xD;
  &#xD;
            2. Patients are 18 years or older (to be adapted for compliance with each country&#xD;
               regulation).&#xD;
  &#xD;
            3. Patients are willing to express their non-opposition to participate in the study.&#xD;
  &#xD;
            4. Patients are able to read and understand the language of questionnaires.&#xD;
  &#xD;
            5. Patients have the cognitive ability to complete the questionnaires.&#xD;
  &#xD;
            6. Patients have had a sufficient experience of the cancer treatment setting :&#xD;
  &#xD;
               a. For outpatients consulting in a chemotherapy day clinic/consultation for oral&#xD;
               treatment, ambulatory radiotherapy or consultation for follow-up surveillance to check&#xD;
               for signs of recurrence : i) between 3 to 6 cycles of chemotherapy or at least 2&#xD;
               cycles of other cancer treatment (e.g., biological oral therapy) or ii) between 2 to 6&#xD;
               weeks of radiotherapy or iii) within the 3rd to 24th month post-cancer treatment. b.&#xD;
               For inpatients consulting on an oncology or a surgery ward at least 3 days of hospital&#xD;
               stay&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded if they are :&#xD;
  &#xD;
            1. Participating in another patient-reported outcome investigation that may interfere&#xD;
               with this study.&#xD;
  &#xD;
            2. Experiencing any psychiatric condition or major cognitive impairment that may hamper&#xD;
               completion of self-reported questionnaires.&#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_contact>
      <last_name>Anne BREDART</last_name>
      <phone>+33 (0)1 44 32 43 50</phone>
      <email>anne.bredart@curie.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institut Curie</name>
        <address>
          <city>Paris</city>
          <zip>75005</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne BREDARD, pHd</last_name>
      </contact>
      <investigator>
        <last_name>Anne BREDART, pHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Institut de Cancérologie de Lorraine</name>
        <address>
          <city>Vandœuvre-lès-Nancy</city>
          <zip>54519</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 11, 2020</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Quality of life</keyword>
    <keyword>Cancer care pathway</keyword>
    <keyword>Patient satisfaction</keyword>
    <keyword>Care improvement</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989191
  org study id: IC 2019-07
  nct id: NCT05989191
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to validate the EORTC PATSAT-C33 and EORTC OUT-PATSAT7
        questionnaires scale structure in a large international field study.
  Patient satisfaction is now recognized as an important indicator of care quality. Measures of
        patient satisfaction with care can facilitate monitoring initiatives for care improvement
        over time. The EORTC Quality of Life Group has cross-culturally validated a stand-alone
        in-patient satisfaction with cancer care questionnaire, the IN-PATSAT32. Advances in cancer
        care delivery required further development of this questionnaire to assess patients'
        perceived quality of the care received in outpatient cancer care settings. Phase I to III of
        this process have been completed, resulting in the EORTC PATSAT-C33 satisfaction with cancer
        care core questionnaire to assess cancer care delivery as a whole and the complementary EORTC
        OUT-PATSAT7, a questionnaire for the specific outpatient care settings. These questionnaires
        concern all patients treated for their cancer, in the assessed service, regardless of the
        stage and type of cancer.
  observational model: Other
  time perspective: Prospective
  measure: Validate the EORTC PATSAT-C33 questionnaire
  time frame: At inclusion
  description: Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires
  measure: Validate the EORTC OUT-PATSAT7 questionnaire
  time frame: At inclusion
  description: Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires
  measure: Cross-cultural applicability and acceptability
  time frame: At inclusion
  description: Adequacy of estimates of cross-cultural applicability and acceptability
  measure: Reliability including test-retest and internal consistency
  time frame: change between inclusion et week 2
  description: Adequacy of estimates for Reliability including test-retest and internal consistency
  measure: Validity, including construct (known-group comparisons)
  time frame: At inclusion
  description: Adequacy of estimates of validity, including construct (known-group comparisons)
  measure: Convergent and divergent validity
  time frame: At inclusion
  description: Adequacy of estimates of convergent and divergent validity
  measure: Responsiveness to change
  time frame: change between inclusion et year 1
  description: Adequacy of estimates of responsiveness to change
  measure: Cross-cultural invariance of psychometric properties
  time frame: At inclusion
  description: Adequacy of estimates of cross-cultural invariance of psychometric properties
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anne BREDART
  phone: +33 (0)1 44 32 43 50
  email: anne.bredart@curie.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Completed
  country: France
  responsible party type: Sponsor
  sharing ipd: No