<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/NCT03821064</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00077402</org_study_id>
    <nct_id>NCT03821064</nct_id>
  </id_info>
  <brief_title>Single-arm Phase II Study of NDURE for Patients With HNC</brief_title>
  <acronym>NDURE</acronym>
  <official_title>Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</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>
      This study will evaluate whether a new patient navigation intervention can decrease delays&#xD;
      starting post-operative radiation therapy after surgery for white and African-American head&#xD;
      and neck cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the feasibility, acceptability, preliminary clinical impact, and&#xD;
      preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation&#xD;
      thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable&#xD;
      post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We&#xD;
      hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white&#xD;
      and African American (AA) HNC patients and decrease disparities in delay between the two&#xD;
      groups by improving system-, interpersonal-, and individual-level health behavior constructs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">November 21, 2019</completion_date>
  <primary_completion_date type="Actual">November 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Patients With a Delay Starting Post-Operative Radiation Treatment</measure>
    <time_frame>6 weeks</time_frame>
    <description>Percent of patients who start PORT &gt;6 weeks after surgery. Initiation of postoperative PORT &gt; 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Difference in PORT Delay Between White and AA HNC Patients.</measure>
    <time_frame>6 weeks</time_frame>
    <description>The difference in the rate of initiation of PORT &gt; 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT &gt;6 weeks after surgery)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients</measure>
    <time_frame>12 weeks</time_frame>
    <description>Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-PORT</measure>
    <time_frame>12 weeks</time_frame>
    <description>Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Pre-Surgical Radiation Consultation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients Surgery to Pathology Reports &lt;/= 7 Days</measure>
    <time_frame>12 weeks</time_frame>
    <description>Surgery to Pathology Report &lt;/= 7 days is defined as the production of the pathology report from the definitive surgical procedure within the electronic medical record (EMR) within 7 calendar days of the definitive surgical procedure. Addenda to the pathology report at the request of the HNC team (e.g. tumor p16 status) are not counted in this measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Referral to PORT Within 10 Days of Surgery</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of patients with surgery to PORT referral &lt;/= 10 days, defined as the placement of a referral for PORT, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With RT Consult Within 10 Days of RT Referral</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of patients with RT Referral to Consult &lt;/= 10 days, defined as the evaluation of the patient at a postoperative consultation with a radiation oncologist within 10 calendar days of the referral being placed (or postoperative appointment being scheduled in cases in which care has been established and the return visit is no longer a consultation). The consultation may occur in the clinic or the hospital depending upon clinical circumstances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Initiation of RT Within 21 Days of Consultation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percent of patients with RT Consult to Initiation &lt;/= 21 days, defined as the initiation of PORT within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers Resolved</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers Unresolved</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Eligible Participants Who Accrue to NDURE</measure>
    <time_frame>13 months</time_frame>
    <description>Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Enrolled Participants Who Complete NDURE</measure>
    <time_frame>13 months</time_frame>
    <description>Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigation Session Completion</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of NDURE navigation sessions completed by a participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigator Caseload</measure>
    <time_frame>13 months</time_frame>
    <description>The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigator Time Allocation (Direct)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigator Time Allocation (Indirect)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With the Interpersonal Relationship With the Navigator Scale Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Logistical Aspects of Navigation Scale Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Perceived Barriers Score From Baseline to End-of-study</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Cancer of Head and Neck</condition>
  <arm_group>
    <arm_group_label>Patient Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45 patients (15 African American, 30 white) will interact with a patient navigator three times over three months to identify and address barriers before they cause breakdowns in care delivery, employing resources, education, and care coordination from the day of surgery until post-operative radiation treatment begins.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Navigation</intervention_name>
    <description>NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
    <arm_group_label>Patient Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Age &gt; 18 years at the time of screening&#xD;
&#xD;
          2. Histologically or pathologically confirmed invasive squamous cell carcinoma (SCC) (or&#xD;
             histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or&#xD;
             unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity.&#xD;
&#xD;
          3. American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition)&#xD;
             for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx,&#xD;
             larynx, paranasal sinuses, and nasal cavity; or AJCC clinical stage grouping III-IV&#xD;
             (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary.&#xD;
&#xD;
          4. No prior exposure to radiation therapy, with or without concurrent chemotherapy, for&#xD;
             treatment of HNSCC in the definitive or adjuvant therapy settings&#xD;
&#xD;
          5. Plan for curative intent surgery at MUSC&#xD;
&#xD;
          6. Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following&#xD;
             curative intent surgery&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Self-identified Hispanic ethnicity&#xD;
&#xD;
          2. Presence of cognitive impairment that precludes participation as determined by&#xD;
             oncology provider&#xD;
&#xD;
          3. Prior radiation therapy for HNC&#xD;
&#xD;
          4. Failure to undergo curative intent surgery at MUSC&#xD;
&#xD;
          5. Lack of indication for PORT (with or without concurrent chemotherapy) per National&#xD;
             Comprehensive Cancer Network (NCCN) Guidelines based on final pathologic evaluation of&#xD;
             adverse features and AJCC pathologic stage grouping&#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>Evan Graboyes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P. Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015 Sep;141(9):804-9. doi: 10.1001/jamaoto.2015.1467.</citation>
    <PMID>26313895</PMID>
  </reference>
  <reference>
    <citation>Cramer JD, Speedy SE, Ferris RL, Rademaker AW, Patel UA, Samant S. National evaluation of multidisciplinary quality metrics for head and neck cancer. Cancer. 2017 Nov 15;123(22):4372-4381. doi: 10.1002/cncr.30902. Epub 2017 Jul 20.</citation>
    <PMID>28727137</PMID>
  </reference>
  <reference>
    <citation>Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 1;21(3):555-63. doi: 10.1200/JCO.2003.04.171. Erratum In: J Clin Oncol. 2003 Apr 1;21(7):1424.</citation>
    <PMID>12560449</PMID>
  </reference>
  <reference>
    <citation>Graboyes EM, Garrett-Mayer E, Ellis MA, Sharma AK, Wahlquist AE, Lentsch EJ, Nussenbaum B, Day TA. Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer. Cancer. 2017 Dec 15;123(24):4841-4850. doi: 10.1002/cncr.30939. Epub 2017 Aug 25.</citation>
    <PMID>28841234</PMID>
  </reference>
  <reference>
    <citation>Graboyes EM, Garrett-Mayer E, Sharma AK, Lentsch EJ, Day TA. Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer. Cancer. 2017 Jul 15;123(14):2651-2660. doi: 10.1002/cncr.30651. Epub 2017 Feb 27.</citation>
    <PMID>28241092</PMID>
  </reference>
  <reference>
    <citation>Divi V, Chen MM, Hara W, Shah D, Narvasa K, Segura Smith A, Kelley J, Rosenthal EL, Porter J. Reducing the Time from Surgery to Adjuvant Radiation Therapy: An Institutional Quality Improvement Project. Otolaryngol Head Neck Surg. 2018 Jul;159(1):158-165. doi: 10.1177/0194599818768254. Epub 2018 Apr 10.</citation>
    <PMID>29631478</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <results_first_submitted>November 22, 2020</results_first_submitted>
  <results_first_submitted_qc>January 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2021</results_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Evan Graboyes</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Otolaryngology- Head and Neck Surgery</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Patient Navigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03821064/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03821064/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NDURE (Patient Navigation)</title>
          <description>NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>did not meet study eligibility criteria of needing adjuvant radiation per NCCN guidelines on path</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NDURE (Patient Navigation)</title>
          <description>NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" lower_limit="46.75" upper_limit="71.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Patients With a Delay Starting Post-Operative Radiation Treatment</title>
        <description>Percent of patients who start PORT &gt;6 weeks after surgery. Initiation of postoperative PORT &gt; 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT.</description>
        <time_frame>6 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With a Delay Starting Post-Operative Radiation Treatment</title>
          <description>Percent of patients who start PORT &gt;6 weeks after surgery. Initiation of postoperative PORT &gt; 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Difference in PORT Delay Between White and AA HNC Patients.</title>
        <description>The difference in the rate of initiation of PORT &gt; 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT &gt;6 weeks after surgery)</description>
        <time_frame>6 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Difference in PORT Delay Between White and AA HNC Patients.</title>
          <description>The difference in the rate of initiation of PORT &gt; 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT &gt;6 weeks after surgery)</description>
          <population>ITT</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients</title>
        <description>Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients</title>
          <description>Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients</description>
          <population>ITT</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time-to-PORT</title>
        <description>Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Time-to-PORT</title>
          <description>Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure.</description>
          <population>ITT</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="36.6" upper_limit="49.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Pre-Surgical Radiation Consultation</title>
        <description>Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Pre-Surgical Radiation Consultation</title>
          <description>Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions</title>
        <description>Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- modified (the endpoint is only evaluable for dentate patients and 3 patients were edentulous and thus not evaluable for the endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions</title>
          <description>Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.</description>
          <population>ITT- modified (the endpoint is only evaluable for dentate patients and 3 patients were edentulous and thus not evaluable for the endpoint)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients Surgery to Pathology Reports &lt;/= 7 Days</title>
        <description>Surgery to Pathology Report &lt;/= 7 days is defined as the production of the pathology report from the definitive surgical procedure within the electronic medical record (EMR) within 7 calendar days of the definitive surgical procedure. Addenda to the pathology report at the request of the HNC team (e.g. tumor p16 status) are not counted in this measure.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients Surgery to Pathology Reports &lt;/= 7 Days</title>
          <description>Surgery to Pathology Report &lt;/= 7 days is defined as the production of the pathology report from the definitive surgical procedure within the electronic medical record (EMR) within 7 calendar days of the definitive surgical procedure. Addenda to the pathology report at the request of the HNC team (e.g. tumor p16 status) are not counted in this measure.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Referral to PORT Within 10 Days of Surgery</title>
        <description>Percent of patients with surgery to PORT referral &lt;/= 10 days, defined as the placement of a referral for PORT, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Referral to PORT Within 10 Days of Surgery</title>
          <description>Percent of patients with surgery to PORT referral &lt;/= 10 days, defined as the placement of a referral for PORT, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With RT Consult Within 10 Days of RT Referral</title>
        <description>Percent of patients with RT Referral to Consult &lt;/= 10 days, defined as the evaluation of the patient at a postoperative consultation with a radiation oncologist within 10 calendar days of the referral being placed (or postoperative appointment being scheduled in cases in which care has been established and the return visit is no longer a consultation). The consultation may occur in the clinic or the hospital depending upon clinical circumstances.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With RT Consult Within 10 Days of RT Referral</title>
          <description>Percent of patients with RT Referral to Consult &lt;/= 10 days, defined as the evaluation of the patient at a postoperative consultation with a radiation oncologist within 10 calendar days of the referral being placed (or postoperative appointment being scheduled in cases in which care has been established and the return visit is no longer a consultation). The consultation may occur in the clinic or the hospital depending upon clinical circumstances.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Initiation of RT Within 21 Days of Consultation</title>
        <description>Percent of patients with RT Consult to Initiation &lt;/= 21 days, defined as the initiation of PORT within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Initiation of RT Within 21 Days of Consultation</title>
          <description>Percent of patients with RT Consult to Initiation &lt;/= 21 days, defined as the initiation of PORT within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.</description>
          <population>ITT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Barriers Resolved</title>
        <description>The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Barriers Resolved</title>
          <description>The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log.</description>
          <population>ITT</population>
          <units>barriers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study</title>
        <description>The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- 3 participants did not complete the questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study</title>
          <description>The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude.</description>
          <population>ITT- 3 participants did not complete the questionnaire</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.86" spread="14.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Barriers Unresolved</title>
        <description>The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Barriers Unresolved</title>
          <description>The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.</description>
          <population>ITT</population>
          <units>unresolved barriers</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Eligible Participants Who Accrue to NDURE</title>
        <description>Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria</description>
        <time_frame>13 months</time_frame>
        <population>eligible patients</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Eligible Participants Who Accrue to NDURE</title>
          <description>Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria</description>
          <population>eligible patients</population>
          <units>percentage of eligible participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Enrolled Participants Who Complete NDURE</title>
        <description>Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment</description>
        <time_frame>13 months</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Enrolled Participants Who Complete NDURE</title>
          <description>Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment</description>
          <population>ITT</population>
          <units>percentage of enrolled participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Navigation Session Completion</title>
        <description>The number of NDURE navigation sessions completed by a participant</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Navigation Session Completion</title>
          <description>The number of NDURE navigation sessions completed by a participant</description>
          <population>ITT</population>
          <units>NDURE sessions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Navigator Caseload</title>
        <description>The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator</description>
        <time_frame>13 months</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Navigator Caseload</title>
          <description>The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator</description>
          <population>ITT</population>
          <units>NDURE participants</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Navigator Time Allocation (Direct)</title>
        <description>The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Navigator Time Allocation (Direct)</title>
          <description>The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy</description>
          <population>ITT</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="60" upper_limit="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Navigator Time Allocation (Indirect)</title>
        <description>The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Navigator Time Allocation (Indirect)</title>
          <description>The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient</description>
          <population>ITT</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120" lower_limit="90" upper_limit="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With the Interpersonal Relationship With the Navigator Scale Score</title>
        <description>The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator).</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- two participants failed to return the end of study questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With the Interpersonal Relationship With the Navigator Scale Score</title>
          <description>The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator).</description>
          <population>ITT- two participants failed to return the end of study questionnaire</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Logistical Aspects of Navigation Scale Score</title>
        <description>This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation).</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- two participants failed to turn in end-of study questionnaires</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Logistical Aspects of Navigation Scale Score</title>
          <description>This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation).</description>
          <population>ITT- two participants failed to turn in end-of study questionnaires</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study</title>
        <description>Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- 3 did not complete the questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study</title>
          <description>Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions.</description>
          <population>ITT- 3 did not complete the questionnaire</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study</title>
        <description>The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- 1 did not complete baseline questionnaire and 2 different participants did not complete end of study questionnaire leaving 7 evaluable paired pre-post data points</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study</title>
          <description>The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support.</description>
          <population>ITT- 1 did not complete baseline questionnaire and 2 different participants did not complete end of study questionnaire leaving 7 evaluable paired pre-post data points</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.14" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study</title>
        <description>The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility.</description>
        <time_frame>12 weeks</time_frame>
        <population>4 participants did not complete a post questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study</title>
          <description>The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility.</description>
          <population>4 participants did not complete a post questionnaire</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study</title>
        <description>The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness.</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- 3 participants did not complete the questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study</title>
          <description>The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness.</description>
          <population>ITT- 3 participants did not complete the questionnaire</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Perceived Barriers Score From Baseline to End-of-study</title>
        <description>The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care</description>
        <time_frame>12 weeks</time_frame>
        <population>ITT- 3 did not complete post-treatment questionnaire</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Perceived Barriers Score From Baseline to End-of-study</title>
          <description>The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care</description>
          <population>ITT- 3 did not complete post-treatment questionnaire</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="3.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from baseline to initiation of postoperative radiation therapy</time_frame>
      <desc>the specific period of time is variable in this study, with end-of study defined as the initiation of postoperative radiation therapy (or 12 weeks if PORT is never started)</desc>
      <group_list>
        <group group_id="E1">
          <title>Patient Navigation</title>
          <description>Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Evan Graboyes (PI)</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-0719</phone>
      <email>graboyes@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03821064
org study id: Pro00077402
nct id: NCT03821064
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate whether a new patient navigation intervention can decrease delays
      starting post-operative radiation therapy after surgery for white and African-American head
      and neck cancer patients.
This study will evaluate the feasibility, acceptability, preliminary clinical impact, and
      preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation
      thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable
      post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We
      hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white
      and African American (AA) HNC patients and decrease disparities in delay between the two
      groups by improving system-, interpersonal-, and individual-level health behavior constructs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent of Patients With a Delay Starting Post-Operative Radiation Treatment
time frame: 6 weeks
description: Percent of patients who start PORT >6 weeks after surgery. Initiation of postoperative PORT > 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT.
measure: Percent Difference in PORT Delay Between White and AA HNC Patients.
time frame: 6 weeks
description: The difference in the rate of initiation of PORT > 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT >6 weeks after surgery)
measure: Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients
time frame: 12 weeks
description: Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients
measure: Time-to-PORT
time frame: 12 weeks
description: Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure.
measure: Percent of Patients With Pre-Surgical Radiation Consultation
time frame: 12 weeks
description: Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting.
measure: Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions
time frame: 12 weeks
description: Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.
measure: Percent of Patients Surgery to Pathology Reports </= 7 Days
time frame: 12 weeks
description: Surgery to Pathology Report </= 7 days is defined as the production of the pathology report from the definitive surgical procedure within the electronic medical record (EMR) within 7 calendar days of the definitive surgical procedure. Addenda to the pathology report at the request of the HNC team (e.g. tumor p16 status) are not counted in this measure.
measure: Percent of Patients With Referral to PORT Within 10 Days of Surgery
time frame: 12 weeks
description: Percent of patients with surgery to PORT referral </= 10 days, defined as the placement of a referral for PORT, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.
measure: Percent of Patients With RT Consult Within 10 Days of RT Referral
time frame: 12 weeks
description: Percent of patients with RT Referral to Consult </= 10 days, defined as the evaluation of the patient at a postoperative consultation with a radiation oncologist within 10 calendar days of the referral being placed (or postoperative appointment being scheduled in cases in which care has been established and the return visit is no longer a consultation). The consultation may occur in the clinic or the hospital depending upon clinical circumstances.
measure: Percent of Patients With Initiation of RT Within 21 Days of Consultation
time frame: 12 weeks
description: Percent of patients with RT Consult to Initiation </= 21 days, defined as the initiation of PORT within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.
measure: Barriers Resolved
time frame: 12 weeks
description: The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log.
measure: Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study
time frame: 12 weeks
description: The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude.
measure: Barriers Unresolved
time frame: 12 weeks
description: The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.
measure: Percent of Eligible Participants Who Accrue to NDURE
time frame: 13 months
description: Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria
measure: Percentage of Enrolled Participants Who Complete NDURE
time frame: 13 months
description: Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment
measure: Navigation Session Completion
time frame: 12 weeks
description: The number of NDURE navigation sessions completed by a participant
measure: Navigator Caseload
time frame: 13 months
description: The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator
measure: Navigator Time Allocation (Direct)
time frame: 12 weeks
description: The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy
measure: Navigator Time Allocation (Indirect)
time frame: 12 weeks
description: The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient
measure: Satisfaction With the Interpersonal Relationship With the Navigator Scale Score
time frame: 12 weeks
description: The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator).
measure: Satisfaction With Logistical Aspects of Navigation Scale Score
time frame: 12 weeks
description: This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation).
measure: Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study
time frame: 12 weeks
description: Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions.
measure: Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study
time frame: 12 weeks
description: The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support.
measure: Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study
time frame: 12 weeks
description: The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility.
measure: Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study
time frame: 12 weeks
description: The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness.
measure: Change in Perceived Barriers Score From Baseline to End-of-study
time frame: 12 weeks
description: The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care
arm group label: Patient Navigation
arm group type: Experimental
description: 45 patients (15 African American, 30 white) will interact with a patient navigator three times over three months to identify and address barriers before they cause breakdowns in care delivery, employing resources, education, and care coordination from the day of surgery until post-operative radiation treatment begins.
intervention type: Other
intervention name: Patient Navigation
description: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
arm group label: Patient Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evan Graboyes, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
citation: Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P. Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015 Sep;141(9):804-9. doi: 10.1001/jamaoto.2015.1467.
PMID: 26313895
citation: Cramer JD, Speedy SE, Ferris RL, Rademaker AW, Patel UA, Samant S. National evaluation of multidisciplinary quality metrics for head and neck cancer. Cancer. 2017 Nov 15;123(22):4372-4381. doi: 10.1002/cncr.30902. Epub 2017 Jul 20.
PMID: 28727137
citation: Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 1;21(3):555-63. doi: 10.1200/JCO.2003.04.171. Erratum In: J Clin Oncol. 2003 Apr 1;21(7):1424.
PMID: 12560449
citation: Graboyes EM, Garrett-Mayer E, Ellis MA, Sharma AK, Wahlquist AE, Lentsch EJ, Nussenbaum B, Day TA. Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer. Cancer. 2017 Dec 15;123(24):4841-4850. doi: 10.1002/cncr.30939. Epub 2017 Aug 25.
PMID: 28841234
citation: Graboyes EM, Garrett-Mayer E, Sharma AK, Lentsch EJ, Day TA. Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer. Cancer. 2017 Jul 15;123(14):2651-2660. doi: 10.1002/cncr.30651. Epub 2017 Feb 27.
PMID: 28241092
citation: Divi V, Chen MM, Hara W, Shah D, Narvasa K, Segura Smith A, Kelley J, Rosenthal EL, Porter J. Reducing the Time from Surgery to Adjuvant Radiation Therapy: An Institutional Quality Improvement Project. Otolaryngol Head Neck Surg. 2018 Jul;159(1):158-165. doi: 10.1177/0194599818768254. Epub 2018 Apr 10.
PMID: 29631478
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Evan Graboyes
investigator title: Assistant Professor, Department of Otolaryngology- Head and Neck Surgery
mesh term: Head and Neck Neoplasms
sharing ipd: No
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