Single-arm Phase II Study of NDURE for Patients With HNC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Other: Patient Navigation


Participation Criteria
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Eligibility Criteria
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In order to be eligible to participate in this study, an individual must meet all of the following criteria: Age > 18 years at the time of screening Histologically or pathologically confirmed invasive squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity. American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity; or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary. No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings Plan for curative intent surgery at MUSC Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery An individual who meets any of the following criteria will be excluded from participation in this study: Self-identified Hispanic ethnicity Presence of cognitive impairment that precludes participation as determined by oncology provider Prior radiation therapy for HNC Failure to undergo curative intent surgery at MUSC Lack of indication for PORT (with or without concurrent chemotherapy) per National Comprehensive Cancer Network (NCCN) Guidelines based on final pathologic evaluation of adverse features and AJCC pathologic stage grouping

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigation<br>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. | Other: Patient Navigation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With a Delay Starting Post-Operative Radiation Treatment | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Difference in PORT Delay Between White and AA HNC Patients. | 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) | 6 weeks | 
| Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients | 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 | 12 weeks | 
| Time-to-PORT | 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. | 12 weeks | 
| Percent of Patients With Pre-Surgical Radiation Consultation | 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. | 12 weeks | 
| Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions | 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. | 12 weeks | 
| Percent of Patients Surgery to Pathology Reports </= 7 Days | 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. | 12 weeks | 
| Percent of Patients With Referral to PORT Within 10 Days of Surgery | 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. | 12 weeks | 
| Percent of Patients With RT Consult Within 10 Days of RT Referral | 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. | 12 weeks | 
| Percent of Patients With Initiation of RT Within 21 Days of Consultation | 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. | 12 weeks | 
| Barriers Resolved | The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log. | 12 weeks | 
| Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study | 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. | 12 weeks | 
| Barriers Unresolved | The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log. | 12 weeks | 
| Percent of Eligible Participants Who Accrue to NDURE | Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria | 13 months | 
| Percentage of Enrolled Participants Who Complete NDURE | 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 | 13 months | 
| Navigation Session Completion | The number of NDURE navigation sessions completed by a participant | 12 weeks | 
| Navigator Caseload | The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator | 13 months | 
| Navigator Time Allocation (Direct) | 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 | 12 weeks | 
| Navigator Time Allocation (Indirect) | The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient | 12 weeks | 
| Satisfaction With the Interpersonal Relationship With the Navigator Scale Score | 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). | 12 weeks | 
| Satisfaction With Logistical Aspects of Navigation Scale Score | 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). | 12 weeks | 
| Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study | 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. | 12 weeks | 
| Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study | 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. | 12 weeks | 
| Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study | 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. | 12 weeks | 
| Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study | 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. | 12 weeks | 
| Change in Perceived Barriers Score From Baseline to End-of-study | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Patient Navigation