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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Other: Patient Navigation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age > 18 years at the time of screening
2. 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.
3. 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.
4. No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
5. Plan for curative intent surgery at MUSC
6. 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:

1. Self-identified Hispanic ethnicity
2. Presence of cognitive impairment that precludes participation as determined by oncology provider
3. Prior radiation therapy for HNC
4. Failure to undergo curative intent surgery at MUSC
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient Navigation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Evan Graboyes, MD, Medical University of South Carolina

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Patient Navigation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Pro00077402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No