<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/NCT03293849</url>
  </required_header>
  <id_info>
    <org_study_id>REF. 2191</org_study_id>
    <nct_id>NCT03293849</nct_id>
  </id_info>
  <brief_title>A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors</brief_title>
  <official_title>A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Global Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a&#xD;
      patient navigator-led generalist palliative and supportive care intervention or in usual care&#xD;
      led by their treating physician. The patient navigator will assess the patient's palliative&#xD;
      and supportive care needs using standardized quality of life and symptoms questionnaires and&#xD;
      present this assessment to a multidisciplinary team composed of oncologists and palliative&#xD;
      care specialist. The multidisciplinary team will develop a personalized supportive care plan&#xD;
      for the patient which will then be presented and discussed by the patient navigator. Those&#xD;
      interventions which are accepted by the patient will be implemented by the patient navigator,&#xD;
      who will also provide education and teaching. The patient navigator will also help eligible&#xD;
      patients complete advanced directives according to local rules and regulations. The patient&#xD;
      navigator will follow the patients both in person and by telephone to ensure that the&#xD;
      recommended interventions have been implemented. Three months after enrollment the patients&#xD;
      will undergo quality of life and symptom assessment once again, and the implementation of&#xD;
      interventions will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 20, 2019</primary_completion_date>
  <phase>N/A</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>Referrals to Supportive Care Services</measure>
    <time_frame>Three months</time_frame>
    <description>Proportion of patients who agree to participate in the patient navigation program, complete the initial assessment, meet with the patient navigator to discuss advanced care planning and supportive care interventions and obtain the appropriate referrals and consultations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of advanced directive completion</measure>
    <time_frame>Three months</time_frame>
    <description>Obtaining a signed advanced directive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implementation of planned supportive care interventions</measure>
    <time_frame>Three months</time_frame>
    <description>Documentation of the planned interventions on the patient's medical record at end-of-study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in QOL</measure>
    <time_frame>Three months</time_frame>
    <description>Changes in QOL measured using the FACT-G from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-reported pain</measure>
    <time_frame>Three months</time_frame>
    <description>Changes in self reported pain measured using the BPI scale from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of chemotherapy at the end of life</measure>
    <time_frame>18 months</time_frame>
    <description>Interval between last administration of chemotherapy and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>18 months</time_frame>
    <description>Sum of hospital admissions, emergency room admissions and ICU admissions during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>18 months</time_frame>
    <description>Overall survival (defined as time from study enrollment to last recorded visit or death)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <arm_group>
    <arm_group_label>Patient Navigation Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After an assessment of supportive care needs, a patient navigator will present assessment results and develop and implement a personalized supportive care intervention plan based on the findings in collaboration with a multidisciplinary supportive care team, formed by oncologists and pain and palliative care specialists. The developed plan will be sent to the treating oncologist and oncology team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Assessment results will be provided in printed and electronic form to the treating oncologist for their review. Referrals or interventions for patients allocated to the control arm will be coordinated by the treating oncologist without involvement from the patient navigator or the study team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Navigation</intervention_name>
    <description>The patient navigator will discuss the results and supportive care recommended interventions of the multidisciplinary team with the patient. Those interventions which are accepted by patient are initiated when possible, and referrals are made as planned. The study patient navigator will review advance directive planning with those patients who are candidates to complete an advanced directive under Mexican law, and will facilitate the resources to complete the advance directive.</description>
    <arm_group_label>Patient Navigation Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients 18 years of age and older&#xD;
&#xD;
          2. Newly diagnosed stage IV solid tumor&#xD;
&#xD;
          3. Recurrent stage IV solid tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Homeless persons&#xD;
&#xD;
          2. History of drug abuse or alcoholism&#xD;
&#xD;
          3. Patients suffering from major psychotic disorders or uncontrolled psychiatric&#xD;
             disorders&#xD;
&#xD;
          4. Mentally disabled patients&#xD;
&#xD;
          5. Incarcerated patients&#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>Enrique Soto Perez de Celis, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</name>
      <address>
        <city>Mexico City</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</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>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293849
org study id: REF. 2191
nct id: NCT03293849
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a
      patient navigator-led generalist palliative and supportive care intervention or in usual care
      led by their treating physician. The patient navigator will assess the patient's palliative
      and supportive care needs using standardized quality of life and symptoms questionnaires and
      present this assessment to a multidisciplinary team composed of oncologists and palliative
      care specialist. The multidisciplinary team will develop a personalized supportive care plan
      for the patient which will then be presented and discussed by the patient navigator. Those
      interventions which are accepted by the patient will be implemented by the patient navigator,
      who will also provide education and teaching. The patient navigator will also help eligible
      patients complete advanced directives according to local rules and regulations. The patient
      navigator will follow the patients both in person and by telephone to ensure that the
      recommended interventions have been implemented. Three months after enrollment the patients
      will undergo quality of life and symptom assessment once again, and the implementation of
      interventions will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Referrals to Supportive Care Services
time frame: Three months
description: Proportion of patients who agree to participate in the patient navigation program, complete the initial assessment, meet with the patient navigator to discuss advanced care planning and supportive care interventions and obtain the appropriate referrals and consultations.
measure: Rate of advanced directive completion
time frame: Three months
description: Obtaining a signed advanced directive
measure: Implementation of planned supportive care interventions
time frame: Three months
description: Documentation of the planned interventions on the patient's medical record at end-of-study
measure: Changes in QOL
time frame: Three months
description: Changes in QOL measured using the FACT-G from baseline.
measure: Changes in self-reported pain
time frame: Three months
description: Changes in self reported pain measured using the BPI scale from baseline.
measure: Use of chemotherapy at the end of life
time frame: 18 months
description: Interval between last administration of chemotherapy and death
measure: Healthcare utilization
time frame: 18 months
description: Sum of hospital admissions, emergency room admissions and ICU admissions during the study period
measure: Survival
time frame: 18 months
description: Overall survival (defined as time from study enrollment to last recorded visit or death)
arm group label: Patient Navigation Arm
arm group type: Experimental
description: After an assessment of supportive care needs, a patient navigator will present assessment results and develop and implement a personalized supportive care intervention plan based on the findings in collaboration with a multidisciplinary supportive care team, formed by oncologists and pain and palliative care specialists. The developed plan will be sent to the treating oncologist and oncology team.
arm group label: Control Arm
arm group type: No Intervention
description: Assessment results will be provided in printed and electronic form to the treating oncologist for their review. Referrals or interventions for patients allocated to the control arm will be coordinated by the treating oncologist without involvement from the patient navigator or the study team.
intervention type: Other
intervention name: Patient Navigation
description: The patient navigator will discuss the results and supportive care recommended interventions of the multidisciplinary team with the patient. Those interventions which are accepted by patient are initiated when possible, and referrals are made as planned. The study patient navigator will review advance directive planning with those patients who are candidates to complete an advanced directive under Mexican law, and will facilitate the resources to complete the advance directive.
arm group label: Patient Navigation Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Enrique Soto Perez de Celis, MD, MSc
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: Undecided