<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/NCT03837132</url>
  </required_header>
  <id_info>
    <org_study_id>H2018:291</org_study_id>
    <nct_id>NCT03837132</nct_id>
  </id_info>
  <brief_title>Early Palliative Care on Quality of Life of Patients With Advanced Pancreas Cancer</brief_title>
  <official_title>The Impact of Early Palliative Care on the Quality of Life of Patients With Advanced Pancreas Cancer: A Case-crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CancerCare Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to explore the impact of early palliative care on quality of life in&#xD;
      patients with advanced pancreatic cancer. The secondary objectives are to explore the impact&#xD;
      of early palliative care on symptom management, depression, anxiety and survival in patients&#xD;
      with advanced pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective case-crossover study of patients with advanced pancreatic cancer (APC)&#xD;
      at CancerCare Manitoba (CCMB) with early palliative care (PALC) plus standard oncologic care.&#xD;
&#xD;
      The primary endpoint of this study is quality of life (QOL) at week 16, measured by the&#xD;
      Functional Assessment of Cancer Therapy - hepatobiliary (FACT-Hep). FACT-hep is a 45-item&#xD;
      tool, which measures physical, emotional, social and functional well-being, and has been&#xD;
      validated in a general population with hepatobiliary cancers, including metastatic pancreatic&#xD;
      cancer. FACT-Hep has strong psychometric properties, and is a reliable, comprehensive and&#xD;
      well-validated scale for use in patients with gastrointestinal cancers.&#xD;
&#xD;
      Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised&#xD;
      Edmonton Symptom Assessment Scale (ESAS-r), (a widely used and validated tool to assess&#xD;
      symptom intensity, which is routinely completed by patients at all CCMB visits); (2)&#xD;
      depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS),&#xD;
      (a-14 item scale which can be used in the outpatient setting to screen for anxiety and&#xD;
      depression within the previous week) and the Patient Health Questionnaire (PHQ-9), (a&#xD;
      sensitive (88%) and specific (88%) 9-question tool which incorporates diagnostic criteria for&#xD;
      major depression); and overall survival measured from date of registration to death.&#xD;
&#xD;
      Recruitment to the study will occur in a clinic staffed by medical oncologists with expertise&#xD;
      in gastrointestinal cancers, as this is the first point of entry into the CCMB system for&#xD;
      patients with APC.&#xD;
&#xD;
      Early PALC will consist of referral to PALC at the time of study enrollment. Patients will&#xD;
      undergo an initial consultation by the PALC team within two weeks of registration. Patients&#xD;
      enrolled in the study who are also receiving chemotherapy must have their initial PALC&#xD;
      consultation before receiving cycle 2 of chemotherapy. Baseline QoL questionnaires may be&#xD;
      completed any time between registration and the first PALC consultation. The PALC team will&#xD;
      be led by a physician with subspecialty training in PALC and an advanced practice nurse, with&#xD;
      the ability to involve other members of the team (dietician, pharmacist, social worker,&#xD;
      psychologist, psychiatrist, spiritual care, home care) as needed. The initial consultation by&#xD;
      the PALC team will consist of assessments as per guidelines set by the Canadian Hospice&#xD;
      Palliative Care Association. Patients will be followed by the PALC team at least every 2&#xD;
      weeks for the first month, then every 4 weeks until week 16, then at the discretion of the&#xD;
      PALC team thereafter. Follow-up PALC visits will occur in person or via telehealth&#xD;
      videoconference. A more intensive follow up regimen will occur early on, with a goal of&#xD;
      achieving symptom control, as APC related symptoms can result in emergency room visits and&#xD;
      hospitalizations. Patients will also receive regular oncologic follow up as directed by their&#xD;
      oncologist.&#xD;
&#xD;
      All patients will complete the FACT-hep, ESAS-r, HADS and PHQ-9 at baseline and every 4 weeks&#xD;
      until week 16. The data collected at these time points will provide a sense of the trajectory&#xD;
      of the patient experience and provide insights into the timing of interventions to improve&#xD;
      management of pain, symptoms, anxiety and depression in the future. Measuring QOL at these&#xD;
      various time points may also be useful in case we experience unexpected loss to follow up at&#xD;
      weeks 16, as it would provide data at intermediate time points for analysis.&#xD;
&#xD;
      Completion of QOL questionnaires will take patients approximately 15-20 minutes (10-15&#xD;
      minutes for FACT-hep), 1-2 minutes for ESAS, 2-3 minutes for HADS, and 1-2 minutes for&#xD;
      PHQ-9). Questionnaires will be completed in the outpatient clinic, at least 7 days after&#xD;
      receiving any chemotherapy to avoid conflation from chemotherapy side effects. All&#xD;
      questionnaires will be collected by a study coordinator, and the study coordinator will be&#xD;
      available to assist patients with questionnaire paperwork as needed. If a patient does not&#xD;
      have an oncology appointment, they may receive the questionnaires and a stamped return&#xD;
      envelope in the mail. If the questionnaires are not returned within 2 weeks, the study&#xD;
      coordinator will contact the patient via phone as a reminder. If necessary, the study&#xD;
      coordinator can complete these in an interview-style format over the telephone.&#xD;
&#xD;
      Patient and treatment characteristics will be captured at baseline, including: age, sex,&#xD;
      education level, height, weight, primary language spoken, Eastern Cooperative Oncology Group&#xD;
      (ECOG) performance status, comorbid illnesses (hypertension, dyslipidemia, diabetes, coronary&#xD;
      artery disease, cerebrovascular accident or transient ischemic attack, psychiatric illness,&#xD;
      other cancers), medications (prescribed, over the counter, alternative/complementary), use of&#xD;
      opioids for cancer related pain, weight loss, clinical stage (locally advanced,&#xD;
      unresectable/metastatic), site of primary tumour in pancreas (head or neck/body/tail), CA&#xD;
      19-9 (normal/elevated). Emergency room visits and hospitalizations while on study will be&#xD;
      captured. This data will be used to describe the study cohort. Data will be entered and&#xD;
      maintained in REDCap on the University of Manitoba's secure research environment.&#xD;
&#xD;
      Note: During the time of the COVID-19 response, patients are assessed over the phone by the&#xD;
      advanced practice nurse two days before their scheduled appointment to determine if in-person&#xD;
      visits are necessary. If in-person visits are necessary, follow up palliative care visits&#xD;
      will be done in clinic with only one support person allowed per patient and clinic visit time&#xD;
      limited to minimize any potential exposure time. In in-person visits not necessary, the&#xD;
      follow up palliative care visits are conducted over the phone until COVID-19 precautions are&#xD;
      lifted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of early palliative care on quality of life in patients with advanced pancreatic cancer</measure>
    <time_frame>registration to 16 weeks</time_frame>
    <description>For the primary endpoint, we will use a generalized linear model to test for a statistically significant change score between baseline and 16 weeks. We will assume a normal distribution for the change scores. Model fit will be assessed via a visual assessment of residuals and the ratio of the model deviance to its degrees of freedom.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer</measure>
    <time_frame>registration to 16 weeks</time_frame>
    <description>Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised Edmonton Symptom Assessment Scale (ESAS-r) (a widely used and validated tool to assess symptom intensity, which is routinely completed by patients at all CCMB visits); (2) depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS) (a 14 item scale which can be used in the outpatient setting to screen for anxiety and depression within the previous week) and the Patient Health Questionnaire (PHQ-9) (a sensitive (88%) and specific (88%) 9 question tool which incorporates diagnostic criteria for major depression); and overall survival measured from date of registration to death</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Advanced pancreatic cancers</arm_group_label>
    <description>Newly diagnosed patients with advanced pancreatic cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Palliative care assessment</intervention_name>
    <description>Patients with advanced pancreatic cancer will have regular palliative care assessment with palliative care team</description>
    <arm_group_label>Advanced pancreatic cancers</arm_group_label>
    <other_name>Early palliative care assessment</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed advanced adult pancreatic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18&#xD;
&#xD;
          -  newly diagnosed advanced pancreatic cancer (APC)&#xD;
&#xD;
          -  English speaking or willing to be seen with a medical interpreter&#xD;
&#xD;
          -  willing and able to complete quality of life (QoL) questionnaires&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18&#xD;
&#xD;
          -  receiving cycle 2 of chemotherapy&#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>Christina Kim, MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>CancerCare Manitoba/ University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Victoria General Hospital Buhler Cancer Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3T 2E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Christina Kim</investigator_full_name>
    <investigator_title>Medical Oncologist, CancerCare Manitoba; Assistant Professor, University of Manitoba</investigator_title>
  </responsible_party>
  <keyword>Advanced Pancreatic Cancer</keyword>
  <keyword>Early Palliative Care</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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/NCT03837132
org study id: H2018:291
nct id: NCT03837132
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to explore the impact of early palliative care on quality of life in
      patients with advanced pancreatic cancer. The secondary objectives are to explore the impact
      of early palliative care on symptom management, depression, anxiety and survival in patients
      with advanced pancreatic cancer.
This is a prospective case-crossover study of patients with advanced pancreatic cancer (APC)
      at CancerCare Manitoba (CCMB) with early palliative care (PALC) plus standard oncologic care.

      The primary endpoint of this study is quality of life (QOL) at week 16, measured by the
      Functional Assessment of Cancer Therapy - hepatobiliary (FACT-Hep). FACT-hep is a 45-item
      tool, which measures physical, emotional, social and functional well-being, and has been
      validated in a general population with hepatobiliary cancers, including metastatic pancreatic
      cancer. FACT-Hep has strong psychometric properties, and is a reliable, comprehensive and
      well-validated scale for use in patients with gastrointestinal cancers.

      Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised
      Edmonton Symptom Assessment Scale (ESAS-r), (a widely used and validated tool to assess
      symptom intensity, which is routinely completed by patients at all CCMB visits); (2)
      depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS),
      (a-14 item scale which can be used in the outpatient setting to screen for anxiety and
      depression within the previous week) and the Patient Health Questionnaire (PHQ-9), (a
      sensitive (88%) and specific (88%) 9-question tool which incorporates diagnostic criteria for
      major depression); and overall survival measured from date of registration to death.

      Recruitment to the study will occur in a clinic staffed by medical oncologists with expertise
      in gastrointestinal cancers, as this is the first point of entry into the CCMB system for
      patients with APC.

      Early PALC will consist of referral to PALC at the time of study enrollment. Patients will
      undergo an initial consultation by the PALC team within two weeks of registration. Patients
      enrolled in the study who are also receiving chemotherapy must have their initial PALC
      consultation before receiving cycle 2 of chemotherapy. Baseline QoL questionnaires may be
      completed any time between registration and the first PALC consultation. The PALC team will
      be led by a physician with subspecialty training in PALC and an advanced practice nurse, with
      the ability to involve other members of the team (dietician, pharmacist, social worker,
      psychologist, psychiatrist, spiritual care, home care) as needed. The initial consultation by
      the PALC team will consist of assessments as per guidelines set by the Canadian Hospice
      Palliative Care Association. Patients will be followed by the PALC team at least every 2
      weeks for the first month, then every 4 weeks until week 16, then at the discretion of the
      PALC team thereafter. Follow-up PALC visits will occur in person or via telehealth
      videoconference. A more intensive follow up regimen will occur early on, with a goal of
      achieving symptom control, as APC related symptoms can result in emergency room visits and
      hospitalizations. Patients will also receive regular oncologic follow up as directed by their
      oncologist.

      All patients will complete the FACT-hep, ESAS-r, HADS and PHQ-9 at baseline and every 4 weeks
      until week 16. The data collected at these time points will provide a sense of the trajectory
      of the patient experience and provide insights into the timing of interventions to improve
      management of pain, symptoms, anxiety and depression in the future. Measuring QOL at these
      various time points may also be useful in case we experience unexpected loss to follow up at
      weeks 16, as it would provide data at intermediate time points for analysis.

      Completion of QOL questionnaires will take patients approximately 15-20 minutes (10-15
      minutes for FACT-hep), 1-2 minutes for ESAS, 2-3 minutes for HADS, and 1-2 minutes for
      PHQ-9). Questionnaires will be completed in the outpatient clinic, at least 7 days after
      receiving any chemotherapy to avoid conflation from chemotherapy side effects. All
      questionnaires will be collected by a study coordinator, and the study coordinator will be
      available to assist patients with questionnaire paperwork as needed. If a patient does not
      have an oncology appointment, they may receive the questionnaires and a stamped return
      envelope in the mail. If the questionnaires are not returned within 2 weeks, the study
      coordinator will contact the patient via phone as a reminder. If necessary, the study
      coordinator can complete these in an interview-style format over the telephone.

      Patient and treatment characteristics will be captured at baseline, including: age, sex,
      education level, height, weight, primary language spoken, Eastern Cooperative Oncology Group
      (ECOG) performance status, comorbid illnesses (hypertension, dyslipidemia, diabetes, coronary
      artery disease, cerebrovascular accident or transient ischemic attack, psychiatric illness,
      other cancers), medications (prescribed, over the counter, alternative/complementary), use of
      opioids for cancer related pain, weight loss, clinical stage (locally advanced,
      unresectable/metastatic), site of primary tumour in pancreas (head or neck/body/tail), CA
      19-9 (normal/elevated). Emergency room visits and hospitalizations while on study will be
      captured. This data will be used to describe the study cohort. Data will be entered and
      maintained in REDCap on the University of Manitoba's secure research environment.

      Note: During the time of the COVID-19 response, patients are assessed over the phone by the
      advanced practice nurse two days before their scheduled appointment to determine if in-person
      visits are necessary. If in-person visits are necessary, follow up palliative care visits
      will be done in clinic with only one support person allowed per patient and clinic visit time
      limited to minimize any potential exposure time. In in-person visits not necessary, the
      follow up palliative care visits are conducted over the phone until COVID-19 precautions are
      lifted.
observational model: Case-Crossover
time perspective: Prospective
measure: Impact of early palliative care on quality of life in patients with advanced pancreatic cancer
time frame: registration to 16 weeks
description: For the primary endpoint, we will use a generalized linear model to test for a statistically significant change score between baseline and 16 weeks. We will assume a normal distribution for the change scores. Model fit will be assessed via a visual assessment of residuals and the ratio of the model deviance to its degrees of freedom.
measure: To explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer
time frame: registration to 16 weeks
description: Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised Edmonton Symptom Assessment Scale (ESAS-r) (a widely used and validated tool to assess symptom intensity, which is routinely completed by patients at all CCMB visits); (2) depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS) (a 14 item scale which can be used in the outpatient setting to screen for anxiety and depression within the previous week) and the Patient Health Questionnaire (PHQ-9) (a sensitive (88%) and specific (88%) 9 question tool which incorporates diagnostic criteria for major depression); and overall survival measured from date of registration to death
arm group label: Advanced pancreatic cancers
description: Newly diagnosed patients with advanced pancreatic cancer
intervention type: Behavioral
intervention name: Palliative care assessment
description: Patients with advanced pancreatic cancer will have regular palliative care assessment with palliative care team
arm group label: Advanced pancreatic cancers
other name: Early palliative care assessment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Kim, MD FRCPC
role: Principal Investigator
affiliation: CancerCare Manitoba/ University of Manitoba
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Christina Kim
investigator title: Medical Oncologist, CancerCare Manitoba; Assistant Professor, University of Manitoba
mesh term: Pancreatic Neoplasms
sharing ipd: No