<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/NCT03245788</url>
  </required_header>
  <id_info>
    <org_study_id>42674</org_study_id>
    <nct_id>NCT03245788</nct_id>
  </id_info>
  <brief_title>Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study</brief_title>
  <official_title>Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the&#xD;
      quality of care and care coordination across the continuum of care. The newest innovation is&#xD;
      to introduce lay navigators to specified high-need patients. The larger goal of the project&#xD;
      is to assess whether lay navigators can address non-clinical patient needs in a timely&#xD;
      fashion and appropriately connect them with their clinical team when warranted. It is&#xD;
      expected that proactive interaction with patients will decrease patient anxiety/stress&#xD;
      related to their cancer and facilitate higher patient engagement and improved management of&#xD;
      physical, social,and emotional health. For the pilot project, the smaller goal is to&#xD;
      understand: how lay navigator time is used; the types and frequency of issues brought up by&#xD;
      patients; resources that patients are given or referred to; type and frequency of mode of&#xD;
      contact with patients; and patients' acceptance of navigators based on refusal. An electronic&#xD;
      intake form will be used to collect this information so that data can be analyzed regularly&#xD;
      to inform changes to the navigator program as needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in&#xD;
      2013. One of the goals of this initiative is to increase patient engagement. The underlying&#xD;
      premise is that engaged patients will be more likely to attend all their visits, receive all&#xD;
      their treatments, and understand ways to manage treatment side effects so that they are less&#xD;
      likely to go to the emergency room (ER) or be admitted to the hospital. An approach being&#xD;
      tested is to use lay navigators to help identify patient issues and help them address the&#xD;
      issues through a combination of direct supportive activities (e.g., calling clinical team for&#xD;
      the patient) and activities that help the patients help themselves (helping them understand&#xD;
      when side effects warrant a call to their clinical team that they make themselves).&#xD;
&#xD;
      Information including patient acceptance/refusal of navigator services; number and types of&#xD;
      contacts with patients (phone, in-person, email); types of issues discussed (financial,&#xD;
      social, educational, physical, emotional, etc); referrals made; and time spent with patients&#xD;
      for each encounter will be routinely entered by the navigators for each patient contact. The&#xD;
      data entered will be evaluated regularly to closely monitor navigator activities and better&#xD;
      understand cancer patient issues/needs. This information will be used to inform possible&#xD;
      training needs of navigators, educational needs of patients,needs for better referral&#xD;
      support,help predict navigator case-load, and other issues.&#xD;
&#xD;
      Eligibility Criteria:&#xD;
&#xD;
      All new biopsy positive cancer patients that have a treatment plan to receive at least 2&#xD;
      treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are&#xD;
      eligible. Because there will be more patients eligible than the navigators can manage, only&#xD;
      patients with an even MRN will receive a navigator for the pilot. The overall purpose of the&#xD;
      pilot is to learn which patients benefit most and which services navigators are able to best&#xD;
      help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used&#xD;
      to evaluate the navigators and will include existing patient experience surveys, unscheduled&#xD;
      hospitalizations, ER visits, interviews with patients, staff (including navigators), and&#xD;
      physicians regarding their experience with and perceived value of navigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 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>There will be 12 groups in each arm which reflects the 12 different cancer types.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking occurs.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Experience/Satisfaction: Difference in topbox scores</measure>
    <time_frame>3-18 months after eligibility is determined</time_frame>
    <description>Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of unplanned hospitalization and ER visits</measure>
    <time_frame>0-18 months after eligibility is determined</time_frame>
    <description>Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Utilization of non-treatment-related cancer services</measure>
    <time_frame>0-18 months after eligibility is determined</time_frame>
    <description>Comparison of the proportion of navigated patients that used non-treatment-related cancer services to those not navigated. Examples of services include palliative care, supportive care, nutrition, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1053</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Gynecologic Cancer</condition>
  <condition>Neck Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Gastrointestinal Cancer</condition>
  <condition>Thoracic Cancer</condition>
  <condition>Cutaneous Tumor</condition>
  <condition>Urologic Cancer</condition>
  <condition>Neurologic Cancer</condition>
  <condition>Lymphoma</condition>
  <condition>Sarcoma</condition>
  <condition>Bone Marrow Transplant</condition>
  <arm_group>
    <arm_group_label>Lay Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with even MRN.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with odd MRN.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lay Navigation</intervention_name>
    <description>Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.</description>
    <arm_group_label>Lay Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patient to eligible Cancer Care Program (CCP)&#xD;
&#xD;
          -  Biopsy positive&#xD;
&#xD;
          -  Plan to receive at least one treatment modality at Stanford: surgery, chemotherapy&#xD;
             and/or radiation therapy&#xD;
&#xD;
          -  Cancer that is treated by any of the following CCPs: Breast, Gynecologic oncology,&#xD;
             Head/neck, Cutaneous (melanoma only), Thoracic, Gastrointestinal&#xD;
&#xD;
          -  Patient has even numbered MRN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone with odd numbered MRN&#xD;
&#xD;
          -  Anyone in other cancer programs that are not included&#xD;
&#xD;
          -  Biopsy negative&#xD;
&#xD;
          -  No treatment modality received&#xD;
&#xD;
          -  Patients with already established care/treatment i.e. not new 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>Steve Asch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Cancer Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res. 2017 Mar;27(4):591-608. doi: 10.1177/1049732316665344. Epub 2016 Sep 26.</citation>
    <PMID>27670770</PMID>
  </reference>
  <reference>
    <citation>O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.</citation>
    <PMID>20851841</PMID>
  </reference>
  <reference>
    <citation>Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.</citation>
    <PMID>20957426</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>May 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Marcy Winget</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Lay Navigator</keyword>
  <keyword>Quality of Care</keyword>
  <keyword>High-Need Cancer Treatment Regimen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Urologic Neoplasms</mesh_term>
    <mesh_term>Skin 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/NCT03245788
org study id: 42674
nct id: NCT03245788
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the
      quality of care and care coordination across the continuum of care. The newest innovation is
      to introduce lay navigators to specified high-need patients. The larger goal of the project
      is to assess whether lay navigators can address non-clinical patient needs in a timely
      fashion and appropriately connect them with their clinical team when warranted. It is
      expected that proactive interaction with patients will decrease patient anxiety/stress
      related to their cancer and facilitate higher patient engagement and improved management of
      physical, social,and emotional health. For the pilot project, the smaller goal is to
      understand: how lay navigator time is used; the types and frequency of issues brought up by
      patients; resources that patients are given or referred to; type and frequency of mode of
      contact with patients; and patients' acceptance of navigators based on refusal. An electronic
      intake form will be used to collect this information so that data can be analyzed regularly
      to inform changes to the navigator program as needed.
The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in
      2013. One of the goals of this initiative is to increase patient engagement. The underlying
      premise is that engaged patients will be more likely to attend all their visits, receive all
      their treatments, and understand ways to manage treatment side effects so that they are less
      likely to go to the emergency room (ER) or be admitted to the hospital. An approach being
      tested is to use lay navigators to help identify patient issues and help them address the
      issues through a combination of direct supportive activities (e.g., calling clinical team for
      the patient) and activities that help the patients help themselves (helping them understand
      when side effects warrant a call to their clinical team that they make themselves).

      Information including patient acceptance/refusal of navigator services; number and types of
      contacts with patients (phone, in-person, email); types of issues discussed (financial,
      social, educational, physical, emotional, etc); referrals made; and time spent with patients
      for each encounter will be routinely entered by the navigators for each patient contact. The
      data entered will be evaluated regularly to closely monitor navigator activities and better
      understand cancer patient issues/needs. This information will be used to inform possible
      training needs of navigators, educational needs of patients,needs for better referral
      support,help predict navigator case-load, and other issues.

      Eligibility Criteria:

      All new biopsy positive cancer patients that have a treatment plan to receive at least 2
      treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are
      eligible. Because there will be more patients eligible than the navigators can manage, only
      patients with an even MRN will receive a navigator for the pilot. The overall purpose of the
      pilot is to learn which patients benefit most and which services navigators are able to best
      help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used
      to evaluate the navigators and will include existing patient experience surveys, unscheduled
      hospitalizations, ER visits, interviews with patients, staff (including navigators), and
      physicians regarding their experience with and perceived value of navigators.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There will be 12 groups in each arm which reflects the 12 different cancer types.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: No masking occurs.
measure: Patient Experience/Satisfaction: Difference in topbox scores
time frame: 3-18 months after eligibility is determined
description: Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients.
measure: Rates of unplanned hospitalization and ER visits
time frame: 0-18 months after eligibility is determined
description: Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients.
measure: Utilization of non-treatment-related cancer services
time frame: 0-18 months after eligibility is determined
description: Comparison of the proportion of navigated patients that used non-treatment-related cancer services to those not navigated. Examples of services include palliative care, supportive care, nutrition, etc.
arm group label: Lay Navigation
arm group type: Experimental
description: Patients with even MRN.
arm group label: Usual Care
arm group type: No Intervention
description: Patients with odd MRN.
intervention type: Other
intervention name: Lay Navigation
description: Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.
arm group label: Lay Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steve Asch, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res. 2017 Mar;27(4):591-608. doi: 10.1177/1049732316665344. Epub 2016 Sep 26.
PMID: 27670770
citation: O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.
PMID: 20851841
citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PMID: 20957426
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Marcy Winget
investigator title: Clinical Associate Professor
mesh term: Head and Neck Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Urologic Neoplasms
mesh term: Skin Neoplasms
sharing ipd: No