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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821064
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Evan Graboyes, Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Other: Patient Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : November 21, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Delays Starting Post-Operative Radiation Treatment [ Time Frame: 6 weeks ]
    Percent of patients (overall, African American, white) 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.


Secondary Outcome Measures :
  1. Racial Disparities Starting PORT, Rate of Delay [ Time Frame: 6 weeks ]
    The difference in the rate of initiation of PORT > 6 weeks after surgery between white and AA HNC patients.

  2. Racial Disparities Starting PORT, Number of Days [ Time Frame: 12 weeks ]
    Difference in number of days from surgery to PORT start (overall, white, AA)

  3. Time-to-PORT [ Time Frame: 12 weeks ]
    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.

  4. PORT Timeline and Care Processes, Pre-Surgical Radiation Consultation [ Time Frame: 12 weeks ]
    Percent of patients with pre-surgical radiation consultation. Pre-Surgical Radiation Consultation is 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.

  5. PORT Timeline and Care Processes, Pre-Radiation Therapy Dental Extractions [ Time Frame: 12 weeks ]
    Percent of patients with on-time dental extractions. Pre-Radiation Therapy Dental Extractions is 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.

  6. PORT Timeline and Care Processes, Surgery to Pathology Reports </= 7 days [ Time Frame: 12 weeks ]
    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.

  7. PORT Timeline and Care Processes, Surgery to PORT Referral <10 days [ Time Frame: 12 weeks ]
    Percent of patients with surgery to PORT referral < 10 days. Surgery to PORT Referral </= 10 days is defined as the placement of a referral for PORT, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.

  8. PORT Timeline and Care Processes, RT Referral to RT Consult <10 days [ Time Frame: 12 weeks ]
    Percent of patients with RT Referral to Consult < 10 days. RT Referral to Consult </= 10 days is 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.

  9. PORT Timeline and Care Processes, RT Consult to Initiation </= 21 days [ Time Frame: 12 weeks ]
    Percent of patients with RT Consult to Initiation </= 21 days. RT Consult to Initiation </= 21 days is defined as the initiation of PORT within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.

  10. Barriers Resolved [ Time Frame: 12 weeks ]
    The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log.

  11. Mechanisms of Barrier Reduction [ Time Frame: 12 weeks ]
    PN Log (type of navigator action for barrier reduction, number of navigator actions for barrier reduction).

  12. Self-Efficacy in Cancer Care [ Time Frame: 12 weeks ]
    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. Higher values represent a more positive attitude.

  13. Barriers Unresolved [ Time Frame: 12 weeks ]
    The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.

  14. NDURE Accrual [ Time Frame: 13 months ]
    The proportion of eligible patients who enroll in NDURE

  15. NDURE Completion [ Time Frame: 13 months ]
    The proportion of enrolled patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment

  16. Navigation Session Completion [ Time Frame: 12 weeks ]
    The number of NDURE navigation sessions completed by a participant

  17. Navigator Caseload [ Time Frame: 13 months ]
    The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator

  18. Navigator Time Allocation (Direct) [ Time Frame: 12 weeks ]
    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

  19. Navigator Time Allocation (Indirect) [ Time Frame: 12 weeks ]
    The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient

  20. Satisfaction with the Interpersonal Relationship with the Navigator Scale Score [ Time Frame: 12 weeks ]
    This scale is a validated, 9-item measure of the satisfaction of the interpersonal relationship with the patient navigator that has been used in prior studies of PN.

  21. Satisfaction with Logistical Aspects of Navigation Scale Score [ Time Frame: 12 weeks ]
    This scale is a validated, 26-item measure of the satisfaction of the logistical aspects of PN that has been used in prior studies of PN

  22. Care Transition Measure-15 (CTM-15) Score [ Time Frame: 12 weeks ]
    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. Higher scores reflect higher levers of care integration and coordination.

  23. Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score [ Time Frame: 12 weeks ]
    Interpersonal Support Evaluation List-12 (ISEL-12) is a validated, 12-item assessment of three domains of interpersonal support that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale with higher scores indicating more support.

  24. Change in Perceived Susceptibility Questionnaire Score [ Time Frame: 12 weeks ]
    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 with higher scores indicating higher perceived susceptibility.

  25. Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score [ Time Frame: 12 weeks ]
    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. It is scored using a 5-point Likert scale with higher scores indicate higher perceived severity.

  26. Change in Perceived Barriers Score [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821064


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Evan Graboyes, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Evan Graboyes, Medical University of South Carolina:
Informed Consent Form  [PDF] July 31, 2019

Publications:

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Responsible Party: Evan Graboyes, Assistant Professor, Department of Otolaryngology- Head and Neck Surgery, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03821064    
Other Study ID Numbers: Pro00077402
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evan Graboyes, Medical University of South Carolina:
Cancer
Patient Navigation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms