<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/NCT03307200</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2017/0350</org_study_id>
    <nct_id>NCT03307200</nct_id>
  </id_info>
  <brief_title>Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy</brief_title>
  <official_title>A Prospective Observational Study on the Unmet Supportive Care Needs of Bladder Cancer Patients Undergoing Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
      Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer.&#xD;
      Healthcare must respond to the specific needs of the patients to provide patient-centered&#xD;
      care. To date, research on the unmet supportive care needs in bladder cancer patients&#xD;
      undergoing radical cystectomy is scarce. Because the needs of the patients may differ&#xD;
      according to the phase in the illness trajectory, it is important that prospective research&#xD;
      is carried out. Research in other cancer populations shows that unmet supportive care needs&#xD;
      are negatively associated with health-related quality of life, psychological distress,&#xD;
      physical activity and the health literacy of the patient. By incorporating the above factors&#xD;
      into this study, we can not only map the unmet supportive care needs of the patient, but also&#xD;
      explore possible associations between the variables. Since this is the first prospective&#xD;
      study on supportive care needs in bladder cancer, this is a hypothesis-generating study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">August 27, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Change in Unmet supportive care needs</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the 34-item supportive care needs survey (SCNS-34)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Cancer-specific Health-related quality of life</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the EORTC-qlq-c30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bladder cancer-specific Health-related quality of life</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the EORTC-qlq-blm30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Psychological distress</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the distress thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in problems associated with psychological distress</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the problem list</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health literacy</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed with the BRIEF Health Literacy Screening Tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical activity pattern</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with the Godin Leisure-Time Exercise Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity Stage of change</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Assessed with a questionnaire based on an algorithm made by Marcus et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The use of health care services</measure>
    <time_frame>From baseline up to 1 year</time_frame>
    <description>Separate questions where the patient is asked about his/her use of supportive health care services.</description>
  </secondary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Bladder Cancer</condition>
  <condition>Urologic Cancer</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with bladder cancer who will undergo radical cystectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age is 18 years or older&#xD;
&#xD;
          -  Patients diagnosed with bladder cancer who will undergo radical cystectomy&#xD;
&#xD;
          -  Patient has to be able to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastatic cancer&#xD;
&#xD;
          -  Presence of a second primary tumor with the exception of fully deleted prostate&#xD;
             cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Valérie Fonteyne, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gent University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Supportive care</keyword>
  <keyword>Prospective observational study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Urologic Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03307200
org study id: EC/2017/0350
nct id: NCT03307200
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer.
      Healthcare must respond to the specific needs of the patients to provide patient-centered
      care. To date, research on the unmet supportive care needs in bladder cancer patients
      undergoing radical cystectomy is scarce. Because the needs of the patients may differ
      according to the phase in the illness trajectory, it is important that prospective research
      is carried out. Research in other cancer populations shows that unmet supportive care needs
      are negatively associated with health-related quality of life, psychological distress,
      physical activity and the health literacy of the patient. By incorporating the above factors
      into this study, we can not only map the unmet supportive care needs of the patient, but also
      explore possible associations between the variables. Since this is the first prospective
      study on supportive care needs in bladder cancer, this is a hypothesis-generating study.
observational model: Cohort
time perspective: Prospective
measure: Change in Unmet supportive care needs
time frame: From baseline up to 1 year
description: Assessed with the 34-item supportive care needs survey (SCNS-34)
measure: Change in Cancer-specific Health-related quality of life
time frame: From baseline up to 1 year
description: Assessed with the EORTC-qlq-c30
measure: Change in Bladder cancer-specific Health-related quality of life
time frame: From baseline up to 1 year
description: Assessed with the EORTC-qlq-blm30
measure: Change in Psychological distress
time frame: From baseline up to 1 year
description: Assessed with the distress thermometer
measure: Change in problems associated with psychological distress
time frame: From baseline up to 1 year
description: Assessed with the problem list
measure: Health literacy
time frame: Baseline
description: Assessed with the BRIEF Health Literacy Screening Tool
measure: Change in Physical activity pattern
time frame: From baseline up to 1 year
description: Assessed with the Godin Leisure-Time Exercise Questionnaire
measure: Change in Physical Activity Stage of change
time frame: From baseline up to 1 year
description: Assessed with a questionnaire based on an algorithm made by Marcus et al.
measure: Change in The use of health care services
time frame: From baseline up to 1 year
description: Separate questions where the patient is asked about his/her use of supportive health care services.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Valérie Fonteyne, MD, PhD
role: Principal Investigator
affiliation: Gent University
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Urologic Neoplasms