xml: <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/NCT06013228</url>
    </required_header>
    <id_info>
      <org_study_id>202302123RIND</org_study_id>
      <nct_id>NCT06013228</nct_id>
    </id_info>
    <brief_title>Trajectories of Fatigue and Quality of Life in People With Both Operable Pancreatic Cancer and Diabetes Mellitus</brief_title>
    <official_title>Trajectories of Fatigue, Glycated Hemoglobin, Diabetes Self-management, and Quality of Life in People With a Dual Diagnosis of Operable Pancreatic Cancer and Diabetes Mellitus: A Longitudinal Mixed-methods Study</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>
        In people with both burdens of OPC and DM, fatigue is the most common and deliberating&#xD;
        symptom that likely impacts their quality of life and diabetes self-management. However,&#xD;
        little is known about the longitudinal relationships among fatigue, its influencing factors,&#xD;
        glycemic status, diabetes self-management, and quality of life in people with both OPC and DM&#xD;
        during the first-year post-operation. Thus, the purposes of this study are to (1) describe&#xD;
        the trajectories of fatigue, HbA1c, diabetes self-management, and quality of life in people&#xD;
        with OPC and DM within 12 months post-operation; (2) examine the relationships among the&#xD;
        trajectories of fatigue, its influencing factors, diabetes self-management, and quality of&#xD;
        life in people with OPC and DM; and (3) understand the experiences of people with both OPC&#xD;
        and DM regarding changes in challenges with diabetes, fatigue, diabetes self-management,&#xD;
        diabetes care needs, and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pancreatic cancer is a devastating disease, and surgery is one of the treatment options with&#xD;
        the goal of curing the disease. However, people with operable pancreatic cancer (OPC) often&#xD;
        have a high prevalence of comorbid diabetes mellitus (DM) that is likely to result in&#xD;
        increased glucose fluctuation and poor glycemic control. Importantly, in people with both&#xD;
        burdens of OPC and DM, fatigue is the most common and deliberating symptom that likely&#xD;
        impacts their quality of life and diabetes self-management. However, little is known about&#xD;
        the longitudinal relationships among fatigue, its influencing factors, glycemic status,&#xD;
        diabetes self-management, and quality of life in people with both OPC and DM during the&#xD;
        first-year post-operation. Thus, the purposes of this study are to (1) describe the&#xD;
        trajectories of fatigue, HbA1c, diabetes self-management, and quality of life in people with&#xD;
        OPC and DM within 12 months post-operation; (2) examine the relationships among the&#xD;
        trajectories of fatigue, its influencing factors, diabetes self-management, and quality of&#xD;
        life in people with OPC and DM; and (3) understand the experiences of people with both OPC&#xD;
        and DM regarding changes in challenges with diabetes, fatigue, diabetes self-management,&#xD;
        diabetes care needs, and quality of life. Guided by the Theory of unpleasant symptoms, this&#xD;
        two-year study will use a longitudinal concurrent mixed methods design. Participants will be&#xD;
        recruited from an outpatient pancreatic surgical department at a medical center in northern&#xD;
        Taiwan using purposive sampling. For the quantitative component, data will be collected using&#xD;
        structured questionnaires over five-time points (i.e., at 1 [first outpatient department&#xD;
        follow-up since discharge from the hospital], 3, 6, 9, and 12 months post pancreatic&#xD;
        resection). The Chinese version of a structured questionnaire, including the demographic and&#xD;
        clinical characteristics form, Diabetes Distress Scale, Center for Epidemiological Studies&#xD;
        Depression Scale, Multidimensional Scale of Perceived Social Support, Fatigue Symptom&#xD;
        Inventory, Summary of Diabetes Self-Care Activities, and the European Organization for&#xD;
        Research and Treatment of Cancer Core Quality of Life Questionnaire will be used. For data&#xD;
        analysis, latent growth curve modeling under a structural equation modeling framework using&#xD;
        Mplus version 8.6 will be performed. A sample of 115 participants with both OPC and DM will&#xD;
        be recruited. To illuminate our understanding of the findings from the quantitative component&#xD;
        of the study, the qualitative component will use semi-structured qualitative interviews to&#xD;
        explore the changes in challenges with diabetes, fatigue, diabetes self-management, diabetes&#xD;
        care needs, and quality of life for a subsample of 20 participants who reported their fatigue&#xD;
        intensity scores as 4 or more on the Fatigue Symptom Inventory concurrently. Qualitative&#xD;
        content analysis will be used to analyze the qualitative data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 23, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Fatigue</measure>
      <time_frame>1, 3, 6, 9, 12 months post operation for pancreatic cancer</time_frame>
      <description>Fatigue Symptom Inventory</description>
    </primary_outcome>
    <enrollment type="Anticipated">115</enrollment>
    <condition>Pancreatic Cancer Resectable</condition>
    <condition>Diabetes Mellitus</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The participants will be recruited from a pancreatic surgical outpatient department (OPD)&#xD;
          at a medical center located in northern Taiwan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  people who (1) have operable pancreatic cancer and are at their first outpatient&#xD;
               department follow-up since discharge from the hospital, (2) are diagnosed with&#xD;
               diabetes mellitus, (3) are aged 18 or above, (4) can communicate in Mandarin or&#xD;
               Taiwanese, and (5) agree to participate and sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  people who (1) are under active treatment for cancer other than pancreatic cancer, (2)&#xD;
               have a cognitive impairment, (3) do not know that they have pancreatic cancer, and (4)&#xD;
               have been diagnosed with chronic fatigue syndrome or fibromyalgia.&#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_official>
      <last_name>Hsuan-Ju Kuo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hsuan-Ju Kuo, PhD</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>288439</phone_ext>
      <email>hsuanjukuo@ntu.edu.tw</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data (IPD) will only be available to other researchers on reasonable request and only de-identified data will potentially be available to protect the rights of the participants.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013228
  org study id: 202302123RIND
  nct id: NCT06013228
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In people with both burdens of OPC and DM, fatigue is the most common and deliberating
        symptom that likely impacts their quality of life and diabetes self-management. However,
        little is known about the longitudinal relationships among fatigue, its influencing factors,
        glycemic status, diabetes self-management, and quality of life in people with both OPC and DM
        during the first-year post-operation. Thus, the purposes of this study are to (1) describe
        the trajectories of fatigue, HbA1c, diabetes self-management, and quality of life in people
        with OPC and DM within 12 months post-operation; (2) examine the relationships among the
        trajectories of fatigue, its influencing factors, diabetes self-management, and quality of
        life in people with OPC and DM; and (3) understand the experiences of people with both OPC
        and DM regarding changes in challenges with diabetes, fatigue, diabetes self-management,
        diabetes care needs, and quality of life.
  Pancreatic cancer is a devastating disease, and surgery is one of the treatment options with
        the goal of curing the disease. However, people with operable pancreatic cancer (OPC) often
        have a high prevalence of comorbid diabetes mellitus (DM) that is likely to result in
        increased glucose fluctuation and poor glycemic control. Importantly, in people with both
        burdens of OPC and DM, fatigue is the most common and deliberating symptom that likely
        impacts their quality of life and diabetes self-management. However, little is known about
        the longitudinal relationships among fatigue, its influencing factors, glycemic status,
        diabetes self-management, and quality of life in people with both OPC and DM during the
        first-year post-operation. Thus, the purposes of this study are to (1) describe the
        trajectories of fatigue, HbA1c, diabetes self-management, and quality of life in people with
        OPC and DM within 12 months post-operation; (2) examine the relationships among the
        trajectories of fatigue, its influencing factors, diabetes self-management, and quality of
        life in people with OPC and DM; and (3) understand the experiences of people with both OPC
        and DM regarding changes in challenges with diabetes, fatigue, diabetes self-management,
        diabetes care needs, and quality of life. Guided by the Theory of unpleasant symptoms, this
        two-year study will use a longitudinal concurrent mixed methods design. Participants will be
        recruited from an outpatient pancreatic surgical department at a medical center in northern
        Taiwan using purposive sampling. For the quantitative component, data will be collected using
        structured questionnaires over five-time points (i.e., at 1 [first outpatient department
        follow-up since discharge from the hospital], 3, 6, 9, and 12 months post pancreatic
        resection). The Chinese version of a structured questionnaire, including the demographic and
        clinical characteristics form, Diabetes Distress Scale, Center for Epidemiological Studies
        Depression Scale, Multidimensional Scale of Perceived Social Support, Fatigue Symptom
        Inventory, Summary of Diabetes Self-Care Activities, and the European Organization for
        Research and Treatment of Cancer Core Quality of Life Questionnaire will be used. For data
        analysis, latent growth curve modeling under a structural equation modeling framework using
        Mplus version 8.6 will be performed. A sample of 115 participants with both OPC and DM will
        be recruited. To illuminate our understanding of the findings from the quantitative component
        of the study, the qualitative component will use semi-structured qualitative interviews to
        explore the changes in challenges with diabetes, fatigue, diabetes self-management, diabetes
        care needs, and quality of life for a subsample of 20 participants who reported their fatigue
        intensity scores as 4 or more on the Fatigue Symptom Inventory concurrently. Qualitative
        content analysis will be used to analyze the qualitative data.
  observational model: Cohort
  time perspective: Prospective
  measure: Fatigue
  time frame: 1, 3, 6, 9, 12 months post operation for pancreatic cancer
  description: Fatigue Symptom Inventory
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hsuan-Ju Kuo, PhD
  role: Principal Investigator
  affiliation: National Taiwan University
  last name: Hsuan-Ju Kuo, PhD
  phone: +886-2-23123456
  phone ext: 288439
  email: hsuanjukuo@ntu.edu.tw
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  mesh term: Diabetes Mellitus
  sharing ipd: No
  ipd description: Individual participant data (IPD) will only be available to other researchers on reasonable request and only de-identified data will potentially be available to protect the rights of the participants.