<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/NCT03766945</url>
  </required_header>
  <id_info>
    <org_study_id>201705112RINB</org_study_id>
    <nct_id>NCT03766945</nct_id>
  </id_info>
  <brief_title>Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery</brief_title>
  <official_title>A Survey of Fatigue and QoL Among Gastric Cancer Patients Undergoing Major Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Background: Cancer-related fatigue (CRF), one of the indicators of QoL, is one of the most&#xD;
      common side effects of cancer and its treatment. However, the pathophysiological mechanisms&#xD;
      involved in CRF among cancer patients are not completely understood. Therefore, more in-depth&#xD;
      researches on CRF of surgical patients suffering from gastric cancer are needed in Taiwan.&#xD;
&#xD;
      Purpose: The purpose of this study is to examine the incidence rate and correlated factors&#xD;
      (QoL and immune biomarkers) of CRF among gastric cancer patients undergoing major abdominal&#xD;
      surgery.&#xD;
&#xD;
      Method: A longitudinal study was conducted to recruit gastric cancer patients who scheduled&#xD;
      to operate at surgical clinics from a northern medical center in Taiwan. The data will be&#xD;
      collected with a structured questionnaire and Immune markers assessments via purposive&#xD;
      sampling of 120 subjects. Before operation, on day 1 after operation, and on day 7 after&#xD;
      operation, the biomarkers will be measured. The BFI-T questionnaire will be filled out before&#xD;
      surgery and on day 1, 2, 7, 28 after surgery; The EORTC QLQ-C30 and EORTC QLQ-STO22&#xD;
      questionnaire will be filled out before surgery and on day 7, 28 after surgery; Type D&#xD;
      scale-14(Taiwanese version) questionnaire will be filled out before surgery and on day 28&#xD;
      after surgery. Data will be analyzed by using descriptive statistics, paired t-test, Chi&#xD;
      square test, Pearson's correlation, and the generalized estimating equation (GEE) was used to&#xD;
      identify significant factors with QoL after operation.&#xD;
&#xD;
      Anticipated achievement: The anticipated achievement of this study is to provide healthcare&#xD;
      providers with more knowledge about CRF, and help them to enhance the quality of life on&#xD;
      gastric cancer patients in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Anticipated">July 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 25, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Change from baseline fatigue at 1 month</time_frame>
    <description>Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Change from baseline quality of life at 1 month</time_frame>
    <description>Quality of Life Questionnaire(EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire). The questionnaire includes 52 items to assess quality of life.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Surgical Wound Infection</condition>
  <condition>Fatigue</condition>
  <condition>Quality of Life</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biomarkers including pre-operative and post-operative serum IFN-gamma, IL-1 beta, IL-4, IL-6,&#xD;
      IL-10 and TNF.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Gastric cancer patients who are scheduled for major abdominal surgery will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of gastric cancer and schedule for major abdominal surgery&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe multiple organ impairment, comorbidities or immune disorder before surgery&#xD;
&#xD;
          2. Undergoing chemotherapy or radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Ming Wu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Ming Wu, PhD</last_name>
    <phone>+886-972652080</phone>
    <email>wujm0531@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shiow-Ching Shun, PhD</last_name>
    <phone>+886-2-23123456</phone>
    <phone_ext>88439</phone_ext>
    <email>scshun@ntu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui-Ting Yang, MSN</last_name>
      <phone>+886930005267</phone>
      <email>sophy790303@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jin-Ming Wu, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shiow-Ching Shun, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <keyword>Surgery</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Surgical Wound</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/NCT03766945
org study id: 201705112RINB
nct id: NCT03766945
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Cancer-related fatigue (CRF), one of the indicators of QoL, is one of the most
      common side effects of cancer and its treatment. However, the pathophysiological mechanisms
      involved in CRF among cancer patients are not completely understood. Therefore, more in-depth
      researches on CRF of surgical patients suffering from gastric cancer are needed in Taiwan.

      Purpose: The purpose of this study is to examine the incidence rate and correlated factors
      (QoL and immune biomarkers) of CRF among gastric cancer patients undergoing major abdominal
      surgery.

      Method: A longitudinal study was conducted to recruit gastric cancer patients who scheduled
      to operate at surgical clinics from a northern medical center in Taiwan. The data will be
      collected with a structured questionnaire and Immune markers assessments via purposive
      sampling of 120 subjects. Before operation, on day 1 after operation, and on day 7 after
      operation, the biomarkers will be measured. The BFI-T questionnaire will be filled out before
      surgery and on day 1, 2, 7, 28 after surgery; The EORTC QLQ-C30 and EORTC QLQ-STO22
      questionnaire will be filled out before surgery and on day 7, 28 after surgery; Type D
      scale-14(Taiwanese version) questionnaire will be filled out before surgery and on day 28
      after surgery. Data will be analyzed by using descriptive statistics, paired t-test, Chi
      square test, Pearson's correlation, and the generalized estimating equation (GEE) was used to
      identify significant factors with QoL after operation.

      Anticipated achievement: The anticipated achievement of this study is to provide healthcare
      providers with more knowledge about CRF, and help them to enhance the quality of life on
      gastric cancer patients in the future.
observational model: Case-Only
time perspective: Other
measure: Fatigue
time frame: Change from baseline fatigue at 1 month
description: Brief Fatigue Inventory-Taiwan Form (BFI-T). The questionnaire includes 10 items to assess fatigue.
measure: Quality of Life
time frame: Change from baseline quality of life at 1 month
description: Quality of Life Questionnaire(EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire). The questionnaire includes 52 items to assess quality of life.
Biomarkers including pre-operative and post-operative serum IFN-gamma, IL-1 beta, IL-4, IL-6,
      IL-10 and TNF.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Ming Wu, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Jin-Ming Wu, PhD
phone: +886-972652080
email: wujm0531@gmail.com
last name: Shiow-Ching Shun, PhD
phone: +886-2-23123456
phone ext: 88439
email: scshun@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Stomach Neoplasms
mesh term: Fatigue
mesh term: Surgical Wound
sharing ipd: No