<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/NCT03305965</url>
  </required_header>
  <id_info>
    <org_study_id>N16NVG</org_study_id>
    <nct_id>NCT03305965</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Patient Navigation in Cancer Care</brief_title>
  <official_title>The Effectiveness of Patient Navigation in Cancer Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Netherlands Cancer Institute</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>
      Rationale: Supportive care such as physical therapy, psycho-social education, and dietary&#xD;
      advice is likely to have a positive effect on the recovery and quality of life of cancer&#xD;
      patients. Currently, not all patients know how to access supportive care, which results in&#xD;
      unmet supportive care needs. This study determines whether these unmet needs can be reduced&#xD;
      or prevented by a patient navigation intervention that focuses on timely screening and&#xD;
      systematic monitoring of patient's supportive care needs.&#xD;
&#xD;
      Objective: The primary objective is to determine the effect of patient navigation on health&#xD;
      related quality of life. Secondary objectives are: 1) to determine the effect of patient&#xD;
      navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to&#xD;
      determine the effect of patient navigation on patients' self-management; 3) to explore how&#xD;
      patient navigation affects the cost-effectiveness of cancer care.&#xD;
&#xD;
      Study design: Longitudinal randomised controlled trial with two study arms: a patient&#xD;
      navigation intervention and care as usual.&#xD;
&#xD;
      Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the&#xD;
      Netherlands Cancer Institute.&#xD;
&#xD;
      Intervention : Consultations with a specifically trained oncology nurse (i.e. patient&#xD;
      navigator), who assesses patients' needs for supportive cancer care, provides information on&#xD;
      supportive cancer care, and guides patients through the supportive cancer care system.&#xD;
      Consultations with the patient navigator take place at the start, halfway through, and at the&#xD;
      end of treatment.&#xD;
&#xD;
      Main study endpoints: The main endpoint of this study is health related quality of life,&#xD;
      which is defined as an individual's perceived emotional, social, physical, and functional&#xD;
      wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Participants are expected to strongly benefit from consulting the patient&#xD;
      navigator without being subjected to any severe risks. Consultations will be provided by&#xD;
      highly qualified professionals, and result in benefits such as decreased severity of&#xD;
      cancer-related psychosocial and physical distress. To minimise burden, face-to-face&#xD;
      consultations will always be scheduled alongside other appointments of at the NKI-AVL.&#xD;
      Furthermore, questionnaire completion takes no more than 30 minutes per data collection&#xD;
      round, of which three are scheduled in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 15, 2016</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</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>
    <intervention_model_description>Patient navigation vs. care as usual</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in health related quality of life</measure>
    <time_frame>Baseline, month 1, month 3, month 5</time_frame>
    <description>EORTC QLQ-C30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in need for supportive cancer care</measure>
    <time_frame>Baseline, month 1, month 3, month 5</time_frame>
    <description>Distress Thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with (supportive) cancer care</measure>
    <time_frame>Month 5</time_frame>
    <description>(Adapted version of) Patient Satisfaction with Cancer Care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of supportive cancer care</measure>
    <time_frame>Baseline, month 1, month 3, month 5</time_frame>
    <description>(Adapted version of) Medical Consumption Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-management</measure>
    <time_frame>Baseline, month 1, month 3, month 5</time_frame>
    <description>Study specific questions on knowledge and self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in work productivity</measure>
    <time_frame>Baseline and month 5</time_frame>
    <description>Study specific questions on work productivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health status</measure>
    <time_frame>Baseline and month 5</time_frame>
    <description>EQ-5D-5L</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patient navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Care as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient navigation</intervention_name>
    <description>Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.</description>
    <arm_group_label>Patient navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with lung, melanoma, urology or gynecology related cancer&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Treated at the Dutch Cancer Institute&#xD;
&#xD;
          -  Has not started treatment at the Dutch Cancer Institute&#xD;
&#xD;
          -  18 years of age and over&#xD;
&#xD;
          -  Curative or palliative treatment&#xD;
&#xD;
          -  Able to understands and speak Dutch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to sign the consent form&#xD;
&#xD;
          -  Not willing to meet with the patient navigator&#xD;
&#xD;
          -  Not willing to complete questionnaires at any point in time&#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>Eveline Bleiker, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The Netherlands Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dutch Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03305965
org study id: N16NVG
nct id: NCT03305965
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Rationale: Supportive care such as physical therapy, psycho-social education, and dietary
      advice is likely to have a positive effect on the recovery and quality of life of cancer
      patients. Currently, not all patients know how to access supportive care, which results in
      unmet supportive care needs. This study determines whether these unmet needs can be reduced
      or prevented by a patient navigation intervention that focuses on timely screening and
      systematic monitoring of patient's supportive care needs.

      Objective: The primary objective is to determine the effect of patient navigation on health
      related quality of life. Secondary objectives are: 1) to determine the effect of patient
      navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to
      determine the effect of patient navigation on patients' self-management; 3) to explore how
      patient navigation affects the cost-effectiveness of cancer care.

      Study design: Longitudinal randomised controlled trial with two study arms: a patient
      navigation intervention and care as usual.

      Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the
      Netherlands Cancer Institute.

      Intervention : Consultations with a specifically trained oncology nurse (i.e. patient
      navigator), who assesses patients' needs for supportive cancer care, provides information on
      supportive cancer care, and guides patients through the supportive cancer care system.
      Consultations with the patient navigator take place at the start, halfway through, and at the
      end of treatment.

      Main study endpoints: The main endpoint of this study is health related quality of life,
      which is defined as an individual's perceived emotional, social, physical, and functional
      wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Participants are expected to strongly benefit from consulting the patient
      navigator without being subjected to any severe risks. Consultations will be provided by
      highly qualified professionals, and result in benefits such as decreased severity of
      cancer-related psychosocial and physical distress. To minimise burden, face-to-face
      consultations will always be scheduled alongside other appointments of at the NKI-AVL.
      Furthermore, questionnaire completion takes no more than 30 minutes per data collection
      round, of which three are scheduled in this study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient navigation vs. care as usual
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in health related quality of life
time frame: Baseline, month 1, month 3, month 5
description: EORTC QLQ-C30
measure: Change in need for supportive cancer care
time frame: Baseline, month 1, month 3, month 5
description: Distress Thermometer
measure: Satisfaction with (supportive) cancer care
time frame: Month 5
description: (Adapted version of) Patient Satisfaction with Cancer Care
measure: Change in consumption of supportive cancer care
time frame: Baseline, month 1, month 3, month 5
description: (Adapted version of) Medical Consumption Questionnaire
measure: Change in self-management
time frame: Baseline, month 1, month 3, month 5
description: Study specific questions on knowledge and self-efficacy
measure: Change in work productivity
time frame: Baseline and month 5
description: Study specific questions on work productivity
measure: Change in health status
time frame: Baseline and month 5
description: EQ-5D-5L
arm group label: Patient navigation
arm group type: Experimental
arm group label: Care as usual
arm group type: No Intervention
intervention type: Behavioral
intervention name: Patient navigation
description: Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.
arm group label: Patient navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eveline Bleiker, PhD
role: Study Director
affiliation: The Netherlands Cancer Institute
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: Undecided