<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/NCT02988635</url>
  </required_header>
  <id_info>
    <org_study_id>RERSCE35E13</org_study_id>
    <nct_id>NCT02988635</nct_id>
  </id_info>
  <brief_title>Early Palliative Care on Quality of Life of Advanced Cancer Patients</brief_title>
  <official_title>Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria di Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regione Emilia-Romagna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria di Parma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares two types of care - Standard Oncology Care (SOC) and SOC with early&#xD;
      palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see&#xD;
      which is better for improving the quality of life of patients with advanced lung, pancreas,&#xD;
      gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure&#xD;
      patients' quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will complete a baseline FACT-G questionnaire and then will be randomized to a&#xD;
      study group.&#xD;
&#xD;
      Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their&#xD;
      treating oncologist. They will consult with the palliative care team at their request or at&#xD;
      the request of the treating oncologist or of the family. They will complete FACT-G&#xD;
      questionnaire at 12 weeks after enrollment.&#xD;
&#xD;
      Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a&#xD;
      palliative care team (basically composed by a palliative care physician and a palliative care&#xD;
      specialized nurse) at their next medical oncology or infusion visit. They will meet with the&#xD;
      palliative care team at least every three weeks. They will complete FACT-G questionnaire at&#xD;
      12 weeks after enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>compare change in QOL from baseline to 12 weeks between study arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>from date of randomization until date of death or for a minimum of six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource utilization at the end of life (EOL): chemotherapy utilization</measure>
    <time_frame>From date of randomization until death or for a minimum of six months after enrollment</time_frame>
    <description>percentage of patients who died, that in the 30 days preceding the death received chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource utilization at the end of life (EOL): hospital admissions</measure>
    <time_frame>From date of randomization until death or for a minimum of six months after enrollment</time_frame>
    <description>percentage of patients who died, that in the 30 days preceding the death were admitted to hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource utilization at the end of life (EOL): emergency room admissions</measure>
    <time_frame>From date of randomization until death or for a minimum of six months after enrollment</time_frame>
    <description>percentage of patients who died, that in the 30 days preceding the death went to the emergency room</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">281</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Biliary Tract Cancer</condition>
  <arm_group>
    <arm_group_label>Early Palliative Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive standard of care with early palliative care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects receive standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Palliative Care</intervention_name>
    <description>Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.</description>
    <arm_group_label>Early Palliative Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary&#xD;
             tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology&#xD;
             Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or&#xD;
             locally advanced disease (but not susceptible of loco-regional treatments);&#xD;
             eligibility to first-line chemotherapy ± biological agents; life expectancy more than&#xD;
             three months; written informed consent provided; FACT-G questionnaire filled in at&#xD;
             enrollment, before the randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients already receiving care from the PC service or pretreated with chemotherapy ±&#xD;
             biological&#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>VITTORIO FRANCIOSI, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria di Parma</investigator_affiliation>
    <investigator_full_name>Vittorio Franciosi</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Early Palliative Care</keyword>
  <keyword>Simultaneous Care</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract 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/NCT02988635
org study id: RERSCE35E13
nct id: NCT02988635
lead sponsor: 
collaborator: 
has dmc: Yes
This study compares two types of care - Standard Oncology Care (SOC) and SOC with early
      palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see
      which is better for improving the quality of life of patients with advanced lung, pancreas,
      gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure
      patients' quality of life.
The patients will complete a baseline FACT-G questionnaire and then will be randomized to a
      study group.

      Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their
      treating oncologist. They will consult with the palliative care team at their request or at
      the request of the treating oncologist or of the family. They will complete FACT-G
      questionnaire at 12 weeks after enrollment.

      Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a
      palliative care team (basically composed by a palliative care physician and a palliative care
      specialized nurse) at their next medical oncology or infusion visit. They will meet with the
      palliative care team at least every three weeks. They will complete FACT-G questionnaire at
      12 weeks after enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
time frame: Change from baseline to 12 weeks
description: compare change in QOL from baseline to 12 weeks between study arms
measure: Survival
time frame: from date of randomization until date of death or for a minimum of six months
measure: Resource utilization at the end of life (EOL): chemotherapy utilization
time frame: From date of randomization until death or for a minimum of six months after enrollment
description: percentage of patients who died, that in the 30 days preceding the death received chemotherapy
measure: Resource utilization at the end of life (EOL): hospital admissions
time frame: From date of randomization until death or for a minimum of six months after enrollment
description: percentage of patients who died, that in the 30 days preceding the death were admitted to hospital
measure: Resource utilization at the end of life (EOL): emergency room admissions
time frame: From date of randomization until death or for a minimum of six months after enrollment
description: percentage of patients who died, that in the 30 days preceding the death went to the emergency room
arm group label: Early Palliative Care
arm group type: Experimental
description: Subjects receive standard of care with early palliative care.
arm group label: Standard of Care
arm group type: No Intervention
description: Subjects receive standard of care.
intervention type: Other
intervention name: Early Palliative Care
description: Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.
arm group label: Early Palliative Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: VITTORIO FRANCIOSI, M.D.
role: Principal Investigator
affiliation: UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria di Parma
investigator full name: Vittorio Franciosi
investigator title: M.D.
mesh term: Biliary Tract Neoplasms
sharing ipd: No