<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/NCT03231462</url>
  </required_header>
  <id_info>
    <org_study_id>2014-10-035</org_study_id>
    <nct_id>NCT03231462</nct_id>
  </id_info>
  <brief_title>Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients</brief_title>
  <official_title>Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective cohort study examines the impact of perioperative physical activity on&#xD;
      postoperative pulmonary complications among esophageal cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 6, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Pulmonary complications</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>Incidence of pneumonia and atelectasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of quality of life</measure>
    <time_frame>Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery</time_frame>
    <description>The change of quality of life is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The quality of life scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of symptom</measure>
    <time_frame>Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery</time_frame>
    <description>The change of symptoms is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) oesophageal cancer module (OES18). The symptom scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Esophageal Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are diagnosed with eshophageal cancer and scheduled to receive curative&#xD;
        esophagectomy at a single cancer hospital in Seoul, Korea&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are diagnosed with esophageal cancer and scheduled to receive curative&#xD;
             esophagectomy&#xD;
&#xD;
          -  Patients who are able to read and understand the questionnaire&#xD;
&#xD;
          -  Patients who are able to communicate with research personnel&#xD;
&#xD;
          -  Patients who recognize the purpose of this study and provide written informed consent&#xD;
&#xD;
          -  Patients without treatment for psychiatric disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have difficulty for walking&#xD;
&#xD;
          -  Patients with history of other cancer in the last 3 years&#xD;
&#xD;
          -  Patients with neoadjuvant chemotherapy and/or radiation therapy&#xD;
&#xD;
          -  Patients with recurrent esophageal cancer&#xD;
&#xD;
          -  Patients with multiple cancer&#xD;
&#xD;
          -  Foreigner or overseas patients who were not able to regularly participate this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Mog Shim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Young Mog Shim, MD</last_name>
    <phone>+82-2-3410-6491</phone>
    <email>genehee.lee@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae Kyung Lee, MSc</last_name>
      <phone>+82-2-3410-6491</phone>
      <email>jk1230.lee@sbri.co.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03231462
org study id: 2014-10-035
nct id: NCT03231462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective cohort study examines the impact of perioperative physical activity on
      postoperative pulmonary complications among esophageal cancer patients.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary complications
time frame: Within 30 days after surgery
description: Incidence of pneumonia and atelectasis
measure: The change of quality of life
time frame: Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
description: The change of quality of life is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The quality of life scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life.
measure: The change of symptom
time frame: Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery
description: The change of symptoms is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) oesophageal cancer module (OES18). The symptom scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Young Mog Shim, MD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Young Mog Shim, MD
phone: +82-2-3410-6491
email: genehee.lee@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: No