<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/NCT02985502</url>
  </required_header>
  <id_info>
    <org_study_id>201611038RINB</org_study_id>
    <nct_id>NCT02985502</nct_id>
  </id_info>
  <brief_title>The Comparison of Quality of Life in Patients With Pancreatogenic Diabetes After Pancreatectomy</brief_title>
  <official_title>The Comparison and Association of Fatigue, Self-care Activities and Quality of Life in Patients With Pancreatogenic Diabetes Mellitus After Total Pancreatectomy or Pancreaticoduodenectomy</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>
  <brief_summary>
    <textblock>
      Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the&#xD;
      reason why this form of surgery technique is seldom performed. However, with the progress of&#xD;
      medical and surgical care nowadays, patients undergone TP could receive better care in&#xD;
      endocrine and exocrine insufficiency. In addition, with better understanding of benign&#xD;
      pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused&#xD;
      pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the&#xD;
      quality of life of patients with pancreatogenic diabetes after TP is still currently&#xD;
      controversial.&#xD;
&#xD;
      Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care&#xD;
      activities and quality of life in patients with pancreatogenic diabetes after total&#xD;
      pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.&#xD;
&#xD;
      Method: A correlational and comparative cross-sectional approach will be used. The data will&#xD;
      be collected with a structured questionnaire via purposive sampling of 120 subjects in an&#xD;
      outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1)&#xD;
      age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to&#xD;
      participate in the study and sign informed consent. Exclusion criteria will be the patients&#xD;
      diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go&#xD;
      through propensity score matching and will be analyzed by using descriptive statistics,&#xD;
      paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.&#xD;
&#xD;
      Anticipated achievement: The anticipated achievement of this study is to understand the&#xD;
      relationships between fatigue, self-care activities, and quality of life in patients with&#xD;
      pancreatogenic diabetes after pancreas surgery. In addition, through this study, the&#xD;
      influence of diabetes to patients after pancreatic tumor resection can be explored; and the&#xD;
      factors that influence the population's quality of life can be examined. By the filling of&#xD;
      this knowledge gap, intervention can be planned accordingly to help improve the population's&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>1 day at first appointment</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Quality of Life</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Pancreatectomy</condition>
  <arm_group>
    <arm_group_label>pancreatogenic diabetes</arm_group_label>
    <description>patients with pancreatogenic diabetes after pancreatectomy will be recruited</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pancreatogenic diabetes</intervention_name>
    <description>pancreatogenic diabetes</description>
    <arm_group_label>pancreatogenic diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with pancreatogenic diabetes after total pancreatectomy or pancreaticoduodenectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese,&#xD;
             (3) agree to participate in the study and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed with cancer other than pancreatic cancer and under active treatment&#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>Shiow-Ching Shun, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nursing, College of Medicine, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsuan-Ju Kuo, MSN</last_name>
    <phone>+886-929215939</phone>
    <email>kuo108041@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>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsuan-Ju Kuo, MSN</last_name>
      <phone>+886929215939</phone>
      <email>kuo108041@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Shiow-Ching Shun, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hsuan-Ju Kuo, MSN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Pancreatectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02985502
org study id: 201611038RINB
nct id: NCT02985502
lead sponsor: 
Background: Pancreatogenic diabetes resulted from total pancreatectomy(TP) is one of the
      reason why this form of surgery technique is seldom performed. However, with the progress of
      medical and surgical care nowadays, patients undergone TP could receive better care in
      endocrine and exocrine insufficiency. In addition, with better understanding of benign
      pancreatic tumors and pancreatic neuroendocrine tumors, more patients with diffused
      pancreatic disease are diagnosed; hence, the performance of TP may rise. Nevertheless, the
      quality of life of patients with pancreatogenic diabetes after TP is still currently
      controversial.

      Purpose: The purpose of this study is to (1) explore the association of fatigue, self-care
      activities and quality of life in patients with pancreatogenic diabetes after total
      pancreatectomy; (2) compare the data with diabetic patients after pancreaticoduodenectomy.

      Method: A correlational and comparative cross-sectional approach will be used. The data will
      be collected with a structured questionnaire via purposive sampling of 120 subjects in an
      outpatient pancreatic surgical department. Inclusion criteria will be the patients with: (1)
      age 20 or above, (2) conscious clear, can communicate in Mandarin or Taiwanese, (3) agree to
      participate in the study and sign informed consent. Exclusion criteria will be the patients
      diagnosed with cancer other than pancreatic cancer and under active treatment. Data will go
      through propensity score matching and will be analyzed by using descriptive statistics,
      paired t-test, Chi square test, Pearson's correlation, and conditional logistic regression.

      Anticipated achievement: The anticipated achievement of this study is to understand the
      relationships between fatigue, self-care activities, and quality of life in patients with
      pancreatogenic diabetes after pancreas surgery. In addition, through this study, the
      influence of diabetes to patients after pancreatic tumor resection can be explored; and the
      factors that influence the population's quality of life can be examined. By the filling of
      this knowledge gap, intervention can be planned accordingly to help improve the population's
      quality of life.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Quality of Life Questionnaire
time frame: 1 day at first appointment
arm group label: pancreatogenic diabetes
description: patients with pancreatogenic diabetes after pancreatectomy will be recruited
intervention type: Other
intervention name: pancreatogenic diabetes
description: pancreatogenic diabetes
arm group label: pancreatogenic diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Shiow-Ching Shun, PhD
role: Principal Investigator
affiliation: Department of Nursing, College of Medicine, National Taiwan University
last name: Hsuan-Ju Kuo, MSN
phone: +886-929215939
email: kuo108041@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: Diabetes Mellitus