<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/NCT03237884</url>
  </required_header>
  <id_info>
    <org_study_id>EKSG 13/157</org_study_id>
    <secondary_id>IZERZO_142226/1</secondary_id>
    <nct_id>NCT03237884</nct_id>
  </id_info>
  <brief_title>Romanian-Swiss Research Programme IZERZO</brief_title>
  <acronym>IZERZO</acronym>
  <official_title>Reality Map of Integrated Oncology and Palliative Care in Romanian and Swiss Cancer Centres</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palliative Care procedures should be integrated early in the course of disease of patients&#xD;
      with advanced incurable cancer. With this study, where the investigators follow adult&#xD;
      patients with incurable cancer over 6 months or until death (whatever occurs earlier), the&#xD;
      investigators aim to identify patients' needs for Palliative Care interventions (like support&#xD;
      in illness understanding and decision making, symptom management, concrete end-of-life&#xD;
      preparation, and others) and their remembered delivery by health care professionals. The&#xD;
      investigators also collect data on patients care (use of chemotherapy, intensive care in the&#xD;
      last month of life) and quality of death and dying (assessed by post-death-interviews with&#xD;
      bereaved relatives). The aim is to have a &quot;reality map&quot; on current integration of oncology&#xD;
      and palliative care and to test if appropriate Palliative Care interventions predict a better&#xD;
      outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background The integration of Palliative Care (PC) in routine oncological care remains&#xD;
      challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal&#xD;
      disperse settings like Romania. The investigators aim to collect original data (&quot;reality&#xD;
      map&quot;) about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and&#xD;
      specific outcome quality indicators (QI). The investigators also hypothesize that both&#xD;
      predefined cofactors and appropriately delivered KI-PCC will predict quality of care.&#xD;
&#xD;
      Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in&#xD;
      this setting there are no predefined structures, the investigators focus on interventions&#xD;
      perceived by the patient.&#xD;
&#xD;
      Methods The investigators' target population are advanced incurable cancer patients in&#xD;
      different care settings (oncology clinics, Palliative Care centers, and hospice, varying in&#xD;
      size, location (rural, urban) and grade of specialization) representing the heterogeneity of&#xD;
      care in Romania. The investigators characterize the population using demographic data (EAPC&#xD;
      basic dataset amended by country specific data like family structures and income), and&#xD;
      validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of&#xD;
      Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These&#xD;
      KI-PCC include illness understanding, symptom management, decision making, spirituality,&#xD;
      end-of-life-preparation, and network/family support. Further, the investigators collect&#xD;
      defined outcome quality indicators (QI) for the integration (quality of death and dying,&#xD;
      symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In&#xD;
      addition, known, associated cofactors (e.g. comorbidities, living situation) are measured.&#xD;
      The data collection will be longitudinal with monthly follow-ups for at most six months or&#xD;
      until death. Focus groups at each participating center explore local influencing factors both&#xD;
      for KI-PCC and QI. Several steps of quality assurance (source data verification, expert&#xD;
      reviews of anticancer treatment, etc.) are introduced.&#xD;
&#xD;
      The analysis has three elements. First, the investigators will describe the population.&#xD;
      Second, the investigators will map the patient perceived KI-PCC and defined outcome QI.&#xD;
      Third, if data show robust after international expert review, the investigators will test the&#xD;
      hypothesis that appropriate KI-PCC predict quality of care, measured by QI.&#xD;
&#xD;
      Expected impact The investigators expect that their approach will identify gaps in the&#xD;
      integration of oncology and palliative care in their specific settings, focusing, however,&#xD;
      mainly on patient and proxy view and backed by available information from outcome QI. The&#xD;
      conduct of this protocol might also directly have an influence on patient care.&#xD;
&#xD;
      This approach will allow the development of tailored interventions in a next step. The&#xD;
      investigators' approach may also serve as a model to measure the integration of oncology and&#xD;
      palliative care in various settings, focusing on interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Composite Endpoint</measure>
    <time_frame>up to 6 months (or death, whichever occurs first)</time_frame>
    <description>A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), &quot;aggressive&quot; end-of-life-care, and bad quality of death and dying (QODD)</description>
  </primary_outcome>
  <enrollment type="Actual">308</enrollment>
  <condition>Advanced Incurable Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Advanced, incurable cancer patients, adult, without cognitive impairment, with a minimal&#xD;
        symptom burden (defined threshold on IPOS)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stage IV cancer&#xD;
&#xD;
          -  over 18 years&#xD;
&#xD;
          -  minimal symptom burden in IPOS (at least 3 symptoms over or equal 2)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 1, 2, 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitively impaired&#xD;
&#xD;
          -  prognosis less than 1 month according to clinician&#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>Florian Strasser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital of St. Gallen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oncological Institute &quot;Prof. Dr. Ion Chiricuţă&quot;</name>
      <address>
        <city>Cluj</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St.Gallen</name>
      <address>
        <city>St.Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
    <investigator_full_name>Florian Strasser, MD ABHPM</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Oncology</keyword>
  <keyword>advanced incurable cancer (any type)</keyword>
  <keyword>integration</keyword>
  <keyword>development</keyword>
  <keyword>palliative care interventions</keyword>
  <keyword>process indicators</keyword>
  <keyword>Romania</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03237884
org study id: EKSG 13/157
secondary id: IZERZO_142226/1
nct id: NCT03237884
lead sponsor: 
has dmc: Yes
Palliative Care procedures should be integrated early in the course of disease of patients
      with advanced incurable cancer. With this study, where the investigators follow adult
      patients with incurable cancer over 6 months or until death (whatever occurs earlier), the
      investigators aim to identify patients' needs for Palliative Care interventions (like support
      in illness understanding and decision making, symptom management, concrete end-of-life
      preparation, and others) and their remembered delivery by health care professionals. The
      investigators also collect data on patients care (use of chemotherapy, intensive care in the
      last month of life) and quality of death and dying (assessed by post-death-interviews with
      bereaved relatives). The aim is to have a "reality map" on current integration of oncology
      and palliative care and to test if appropriate Palliative Care interventions predict a better
      outcome.
Background The integration of Palliative Care (PC) in routine oncological care remains
      challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal
      disperse settings like Romania. The investigators aim to collect original data ("reality
      map") about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and
      specific outcome quality indicators (QI). The investigators also hypothesize that both
      predefined cofactors and appropriately delivered KI-PCC will predict quality of care.

      Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in
      this setting there are no predefined structures, the investigators focus on interventions
      perceived by the patient.

      Methods The investigators' target population are advanced incurable cancer patients in
      different care settings (oncology clinics, Palliative Care centers, and hospice, varying in
      size, location (rural, urban) and grade of specialization) representing the heterogeneity of
      care in Romania. The investigators characterize the population using demographic data (EAPC
      basic dataset amended by country specific data like family structures and income), and
      validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of
      Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These
      KI-PCC include illness understanding, symptom management, decision making, spirituality,
      end-of-life-preparation, and network/family support. Further, the investigators collect
      defined outcome quality indicators (QI) for the integration (quality of death and dying,
      symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In
      addition, known, associated cofactors (e.g. comorbidities, living situation) are measured.
      The data collection will be longitudinal with monthly follow-ups for at most six months or
      until death. Focus groups at each participating center explore local influencing factors both
      for KI-PCC and QI. Several steps of quality assurance (source data verification, expert
      reviews of anticancer treatment, etc.) are introduced.

      The analysis has three elements. First, the investigators will describe the population.
      Second, the investigators will map the patient perceived KI-PCC and defined outcome QI.
      Third, if data show robust after international expert review, the investigators will test the
      hypothesis that appropriate KI-PCC predict quality of care, measured by QI.

      Expected impact The investigators expect that their approach will identify gaps in the
      integration of oncology and palliative care in their specific settings, focusing, however,
      mainly on patient and proxy view and backed by available information from outcome QI. The
      conduct of this protocol might also directly have an influence on patient care.

      This approach will allow the development of tailored interventions in a next step. The
      investigators' approach may also serve as a model to measure the integration of oncology and
      palliative care in various settings, focusing on interventions.
observational model: Cohort
time perspective: Prospective
measure: Composite Endpoint
time frame: up to 6 months (or death, whichever occurs first)
description: A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), "aggressive" end-of-life-care, and bad quality of death and dying (QODD)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florian Strasser, MD
role: Principal Investigator
affiliation: Cantonal Hospital of St. Gallen
facility: 
facility: 
country: Romania
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Cantonal Hospital of St. Gallen
investigator full name: Florian Strasser, MD ABHPM
investigator title: Principal Investigator
sharing ipd: Undecided