<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/NCT04444544</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00536</org_study_id>
    <nct_id>NCT04444544</nct_id>
  </id_info>
  <brief_title>Quality of Life and High-Risk Abdominal Cancer Surgery</brief_title>
  <acronym>ChangeQoL</acronym>
  <official_title>Changes of Health-related Quality of Life 6 Months After High-risk Oncological Upper Gastrointestinal and Hepatobiliary Surgery: a Single-centre Prospective Observational Study (ChangeQol Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</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 investigators plan to measure the changes of health-related quality of life (HRQoL) at 6&#xD;
      months and 12 months after the following high-risk oncological abdominal surgery:&#xD;
      gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure&#xD;
      the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month&#xD;
      after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement,&#xD;
      stability and deterioration) at 6 months and 12 months after surgery.&#xD;
&#xD;
      The second aim is to assess the regret of the patient at 6 months and 12 months regarding&#xD;
      his/her decision to undergo surgery. The investigators will also assess the regret of the&#xD;
      next of kin at 6 months regarding the decision to undergo surgery.&#xD;
&#xD;
      This descriptive, prospective, observational, single-centre cohort study aims to: identify&#xD;
      phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and&#xD;
      deterioration); assess the regret of patients regarding their decision to undergo surgical&#xD;
      oncology at 6 months and 12 months; assess the regret of the next of kin regarding the&#xD;
      decision of the patient to undergo surgical oncology at 6 months and 12 months. The&#xD;
      investigators will include patients scheduled for the following elective abdominal cancer&#xD;
      surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators&#xD;
      will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12&#xD;
      months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined&#xD;
      using the minimal clinically important difference (MCID) of 10 points. The investigators will&#xD;
      assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery.&#xD;
&#xD;
      The expected results are: The investigators can identify phenotypes of HRQoL changes after&#xD;
      surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the&#xD;
      distribution of these phenotypes and will find an association with the pre-existing frailty.&#xD;
      The investigators can describe the extent of the regret of the patient and of the next of kin&#xD;
      at 6 months using the DRS. The investigators will observe an association between the DRS&#xD;
      score at 6 months and the HRQoL Summary Score change. The investigators will not observe a&#xD;
      relationship between the DRS score of patients and next-of-kins.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 5, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Health-related Quality of Life</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>EORTC-QLQ C30. Minimum 0, Maximum 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Regret</measure>
    <time_frame>6 and 12 months after surgery</time_frame>
    <description>Decision Regret Scale. Minimum 0, Maximum 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>EORTC-QLQ C30. Minimum 0, Maximum 100</description>
  </secondary_outcome>
  <enrollment type="Anticipated">295</enrollment>
  <condition>Quality of Life</condition>
  <condition>Surgery</condition>
  <condition>Cancer</condition>
  <condition>Frailty</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Risk Abdominal Surgery</intervention_name>
    <description>Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elective patients scheduled for high-risk abdominal cancer surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Adult patients (&gt;18 years) scheduled for the following elective abdominal cancer surgery&#xD;
        known for high one-year mortality4: gastrectomy; esophagectomy; pancreas resection and&#xD;
        hepatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with inoperable tumours; i.e. some patients will be excluded at the time of&#xD;
             surgery if unexpected advanced tumour staging is confirmed intraoperatively (e.g.&#xD;
             peritoneal carcinomatosis or any other diagnosis without therapy).&#xD;
&#xD;
          -  Hepatectomy for metastasectomy&#xD;
&#xD;
          -  Mentally impaired patients (known diagnosis)&#xD;
&#xD;
          -  Psychotic diagnoses (i.e. schizophrenia)&#xD;
&#xD;
          -  Dementia (mini mental score (MMSE) &lt; 18)&#xD;
&#xD;
          -  Incapacity to understand the information sheet&#xD;
&#xD;
          -  Blindness (unable to perform the visual part of the mini-mental state examination)&#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>Julien Maillard, MD</last_name>
    <phone>0041787753730</phone>
    <email>julien.maillard@hcuge.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1206</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien Maillard, MD</last_name>
      <phone>0041787753730</phone>
      <email>julien.maillard@hcuge.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Julien Maillard</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Surgery</keyword>
  <keyword>Regret</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</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/NCT04444544
org study id: 2020-00536
nct id: NCT04444544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6
      months and 12 months after the following high-risk oncological abdominal surgery:
      gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure
      the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month
      after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement,
      stability and deterioration) at 6 months and 12 months after surgery.

      The second aim is to assess the regret of the patient at 6 months and 12 months regarding
      his/her decision to undergo surgery. The investigators will also assess the regret of the
      next of kin at 6 months regarding the decision to undergo surgery.

      This descriptive, prospective, observational, single-centre cohort study aims to: identify
      phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and
      deterioration); assess the regret of patients regarding their decision to undergo surgical
      oncology at 6 months and 12 months; assess the regret of the next of kin regarding the
      decision of the patient to undergo surgical oncology at 6 months and 12 months. The
      investigators will include patients scheduled for the following elective abdominal cancer
      surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators
      will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12
      months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined
      using the minimal clinically important difference (MCID) of 10 points. The investigators will
      assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery.

      The expected results are: The investigators can identify phenotypes of HRQoL changes after
      surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the
      distribution of these phenotypes and will find an association with the pre-existing frailty.
      The investigators can describe the extent of the regret of the patient and of the next of kin
      at 6 months using the DRS. The investigators will observe an association between the DRS
      score at 6 months and the HRQoL Summary Score change. The investigators will not observe a
      relationship between the DRS score of patients and next-of-kins.
observational model: Cohort
time perspective: Prospective
measure: Health-related Quality of Life
time frame: 6 months after surgery
description: EORTC-QLQ C30. Minimum 0, Maximum 100
measure: Regret
time frame: 6 and 12 months after surgery
description: Decision Regret Scale. Minimum 0, Maximum 100
measure: Health-related Quality of Life
time frame: 12 months after surgery
description: EORTC-QLQ C30. Minimum 0, Maximum 100
intervention type: Other
intervention name: High Risk Abdominal Surgery
description: Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julien Maillard, MD
phone: 0041787753730
email: julien.maillard@hcuge.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Julien Maillard
investigator title: Principal Investigator
mesh term: Frailty