<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/NCT01718821</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-101-134</org_study_id>
    <nct_id>NCT01718821</nct_id>
  </id_info>
  <brief_title>Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients</brief_title>
  <official_title>Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng Kung University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng Kung University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain is one of the most common symptoms associated with cancer. The approach to pain&#xD;
      management compresses routine pain assessments, utilizes both pharmacologic and&#xD;
      nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain&#xD;
      can be well controlled in the vast majority of patients if the algorithms of pain control are&#xD;
      systematically applied, carefully monitored, and tailored to the needs of the individual&#xD;
      patient.This study is aimed to assess the current pain managements in upper gastrointestinal&#xD;
      cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled&#xD;
      patients would also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain, assessed by BPI-SF.</measure>
    <time_frame>Assessed at enrolled date (Day 1)</time_frame>
    <description>Pain intensities of participants would be assessed by BPI-SF at D1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pain, assessed by BPI-SF.</measure>
    <time_frame>Baseline and 1 month.</time_frame>
    <description>Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression, assessed by two stem questions.</measure>
    <time_frame>Assessed at enrolled date (Day 1)</time_frame>
    <description>Depression of participants would be assessed by questionnaires as mentioned at D1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depression, assessed by two stem questions.</measure>
    <time_frame>Baseline and 1 month.</time_frame>
    <description>Changes in depression status would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life, assessed by EROTC QLQ C30.</measure>
    <time_frame>Day 1</time_frame>
    <description>Quality of life of participants would be assessed by questionnaires as mentioned at D1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathic pain, assessed by DN4 questions.</measure>
    <time_frame>Day 1</time_frame>
    <description>Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.</measure>
    <time_frame>Baseline and 1 month.</time_frame>
    <description>Changes in quality of life would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.</measure>
    <time_frame>Baseline and 1 month.</time_frame>
    <description>Changes in neuropathic pain would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain</condition>
  <condition>Neuropathic Pain</condition>
  <condition>Depression</condition>
  <condition>Quality of Life</condition>
  <condition>Upper GI Cancer</condition>
  <arm_group>
    <arm_group_label>Advanced upper GI cancer patients</arm_group_label>
    <description>Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Admitted patients or out patients in National Cheng Kung University Hospital (a medical&#xD;
        center)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with a diagnose of advanced upper GI cancer based on pathology or imaging studies&#xD;
&#xD;
          -  could report pain intensities and answer questionnaires by him/herself&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with major neurologic or psychiatric diseases&#xD;
&#xD;
          -  could not report pain intensities and answer questionnaires by him/herself&#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>Yea-huei Kao Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng Kung University</investigator_affiliation>
    <investigator_full_name>Hsu-chih Chien</investigator_full_name>
    <investigator_title>Doctoral student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Neuralgia</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/NCT01718821
org study id: A-ER-101-134
nct id: NCT01718821
lead sponsor: 
has dmc: No
Pain is one of the most common symptoms associated with cancer. The approach to pain
      management compresses routine pain assessments, utilizes both pharmacologic and
      nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain
      can be well controlled in the vast majority of patients if the algorithms of pain control are
      systematically applied, carefully monitored, and tailored to the needs of the individual
      patient.This study is aimed to assess the current pain managements in upper gastrointestinal
      cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled
      patients would also be assessed.
observational model: Ecologic or Community
time perspective: Prospective
measure: Pain, assessed by BPI-SF.
time frame: Assessed at enrolled date (Day 1)
description: Pain intensities of participants would be assessed by BPI-SF at D1.
measure: Changes in pain, assessed by BPI-SF.
time frame: Baseline and 1 month.
description: Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
measure: Depression, assessed by two stem questions.
time frame: Assessed at enrolled date (Day 1)
description: Depression of participants would be assessed by questionnaires as mentioned at D1.
measure: Changes in depression, assessed by two stem questions.
time frame: Baseline and 1 month.
description: Changes in depression status would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
measure: Quality of life, assessed by EROTC QLQ C30.
time frame: Day 1
description: Quality of life of participants would be assessed by questionnaires as mentioned at D1.
measure: Neuropathic pain, assessed by DN4 questions.
time frame: Day 1
description: Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.
measure: Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.
time frame: Baseline and 1 month.
description: Changes in quality of life would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
measure: Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.
time frame: Baseline and 1 month.
description: Changes in neuropathic pain would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
arm group label: Advanced upper GI cancer patients
description: Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yea-huei Kao Yang
role: Principal Investigator
affiliation: Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng Kung University
investigator full name: Hsu-chih Chien
investigator title: Doctoral student
mesh term: Gastrointestinal Neoplasms
mesh term: Neuralgia