NCT04098458

Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC

Completed NA Results posted Last updated 22 March 2021

What this trial tests

NA trial testing NDURE in Squamous Cell Carcinoma of Head and Neck in 18 participants. Completed in 14 April 2020.

Timeline

12 September 2019

Primary endpoint
14 April 2020

14 April 2020

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	18
Start date	12 September 2019
Primary completion	14 April 2020
Estimated completion	14 April 2020
Sites	1 location across United States

Drugs / interventions tested

• NDURE

Conditions studied

• Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Eligible Participants Who Accrue to NDURE Primary · 5 months

Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria

Group	Value	95% CI
NDURE	15

Percent of Participants Who Complete the NDURE Intervention and Study Measures Secondary · 5 months

Completion of the baseline assessment, at least two (of 3) NDURE intervention sessions, and the end of study assessment

Group	Value	95% CI
NDURE	14

Satisfaction With the Interpersonal Relationship With the Navigator (PSN-I) Scale Score Secondary · Post-intervention (3 months)

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).

Group	Value	95% CI
NDURE	38	± 2.9

Navigator Caseload Secondary · 5 months

The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator

Group	Value	95% CI
NDURE	3.5	1 – 5

Navigator Time Allocation (Direct) Secondary · 3 months

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.

Group	Value	95% CI
NDURE	96	90 – 135

Navigator Time Allocation (Indirect) Secondary · 3 months

The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient

Group	Value	95% CI
NDURE	135	120 – 195

Navigator Time Allocation (Total) Secondary · 3 months

The time (in minutes), that the NDURE navigator spends directly or indirectly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy

Group	Value	95% CI
NDURE	231	210 – 330

Percent of Patients With a Delay Starting Post-Operative Radiation Treatment Secondary · 6 weeks

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 ea

Group	Value	95% CI
NDURE	2

Percent Difference in PORT Delay Between White and Black Patients With Head and Neck Cancer Secondary · 6 weeks

The difference in the rate of initiation of PORT \> 6 weeks after surgery between white and black patients with head and neck cancer (i.e., percent difference = percent of white patients with PORT delay minus percent of black patients with PORT delay)

Group	Value	95% CI
NDURE	14.2

NDURE Program Evaluation Scale Score: Utility of Sessions With the Navigator Secondary · 3 months

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The sessions meeting with the navigator were useful to help prevent a delay starting radiation therapy after surgery." Higher scores represent higher levels of agreement.

Group	Value	95% CI
NDURE	4.79	± 0.58

NDURE Program Evaluation Scale Score: Timeline of Activities Secondary · 3 months

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The timeline of activities for starting radiation after surgery was useful." Higher scores represent higher levels of agreement.

Group	Value	95% CI
NDURE	4.85	± 0.38

NDURE Program Evaluation Scale Score: Helpful in Identifying Challenges Starting Radiation Therapy Secondary · 3 months

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The navigator was helpful in identifying my specific challenges starting radiation therapy after surgery." Higher scores represent higher levels of agreement.

Group	Value	95% CI
NDURE	4.79	± 0.58

Sponsor's own description

Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, single-arm trial, adults with surgically-managed, locally advanced HNSCC, will be enrolled in NDURE to assess the feasibility and acceptability of NDURE as a novel approach to decreasing delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the accrual rate and NDURE completion rate. Participants will also complete validated questionnaires at baseline and post-intervention to evaluate the feasibility of outcome assessment for NDURE. Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNSCC surgery, thereby improving survival for patients with HNSCC, decreasing racial disparities in mortality, and developing new standards of clinical care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer.
   Graboyes EM, Sterba KR, Li H, Warren GW, et al · · 2021 · cited 40× · PMID 33689399 · DOI 10.1200/op.20.00943