Trial Outcomes & Findings for Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC (NCT NCT04098458)

Last Updated: 2021-03-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

5 months

Results posted on

2021-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	NDURE Navigation for Disparities and Untimely Radiation thErapy (NDURE) is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent postoperative radiation therapy (PORT). NDURE key functions include: 1) Improve patient knowledge about Guidelines for timely PORT and associated care processes; 2) Minimize the burden of travel for HNSCC care; 3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; 4) Enhance care coordination between care teams during care transitions and about treatment sequelae; 5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; 6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	NDURE Navigation for Disparities and Untimely Radiation thErapy (NDURE) is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent postoperative radiation therapy (PORT). NDURE key functions include: 1) Improve patient knowledge about Guidelines for timely PORT and associated care processes; 2) Minimize the burden of travel for HNSCC care; 3) Improve communication between patient and providers regarding intentions and goals for timely, guideline-adherent PORT; 4) Enhance care coordination between care teams during care transitions and about treatment sequelae; 5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; 6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each. The three NDURE sessions coincide with the pre-surgical consult, hospital discharge, and first postoperative visit, time points chosen to facilitate case identification and coordination across care transitions. During each NDURE session, the navigator delivers patient education and creates or updates the PORT Care Plan. Referral tracking and follow-up occurs through asynchronous contact between the navigator, patient, and healthcare organizations between NDURE sessions.
Overall Study Death	1
Overall Study did not meet study inclusion criteria	3

Baseline Characteristics

1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NDURE n=15 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Age, Continuous	65 years n=15 Participants
Sex: Female, Male Female	5 Participants n=15 Participants
Sex: Female, Male Male	10 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	5 Participants n=15 Participants
Race (NIH/OMB) White	10 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants
Health Insurance Coverage Private	6 Participants n=15 Participants
Health Insurance Coverage Medicare	6 Participants n=15 Participants
Health Insurance Coverage Medicaid	1 Participants n=15 Participants
Health Insurance Coverage Self-pay	2 Participants n=15 Participants
Marital Status Married/current partner	8 Participants n=15 Participants
Marital Status Single/separated/divorced/widowed	7 Participants n=15 Participants
Living Situation Spouse/partner	7 Participants n=15 Participants
Living Situation Parents/siblings/children	3 Participants n=15 Participants
Living Situation Self	5 Participants n=15 Participants
Highest Level of Education High school graduate	5 Participants n=15 Participants
Highest Level of Education Some college	4 Participants n=15 Participants
Highest Level of Education College or graduate school	6 Participants n=15 Participants
Employment Full or part-time paid	5 Participants n=15 Participants
Employment Retired	7 Participants n=15 Participants
Employment Disability or unemployed	3 Participants n=15 Participants
Subsite oral cavity	13 Participants n=15 Participants
Subsite Oropharynx (human papillomavirus-related)	1 Participants n=15 Participants
Subsite Paranasal sinus	1 Participants n=15 Participants
American Joint Committee on Cancer Pathologic T Category 1-2	2 Participants n=15 Participants
American Joint Committee on Cancer Pathologic T Category 3-4b	13 Participants n=15 Participants
American Joint Committee on Cancer Pathologic N Category 0-1	11 Participants n=15 Participants
American Joint Committee on Cancer Pathologic N Category 2-3b	4 Participants n=15 Participants
Overall American Joint Committee on Cancer Stage Grouping III	1 Participants n=15 Participants
Overall American Joint Committee on Cancer Stage Grouping IV	14 Participants n=15 Participants
Adjuvant Therapy Radiation	7 Participants n=14 Participants • 1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant
Adjuvant Therapy Chemoradiation	6 Participants n=14 Participants • 1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant
Adjuvant Therapy Immuno-radiation	1 Participants n=14 Participants • 1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant
Fragmentation of Care Between Surgical and Radiation Facilities No	7 Participants n=14 Participants • 1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant
Fragmentation of Care Between Surgical and Radiation Facilities Yes	7 Participants n=14 Participants • 1 participant suffered a mortality prior to initiating adjuvant radiation and the measure is thus not analyzable for this participant

PRIMARY outcome

Timeframe: 5 months

Population: percentage of participants meeting all inclusion/exclusion criteria who accrued to the study

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

Outcome measures

Outcome measures
Measure	NDURE n=17 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Percent of Eligible Participants Who Accrue to NDURE	15 Participants

SECONDARY outcome

Timeframe: 5 months

Population: intention to treat (ITT)

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

Outcome measures

Outcome measures
Measure	NDURE n=15 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Percent of Participants Who Complete the NDURE Intervention and Study Measures	14 Participants

SECONDARY outcome

Timeframe: Post-intervention (3 months)

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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).

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Satisfaction With the Interpersonal Relationship With the Navigator (PSN-I) Scale Score	38 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 5 months

Population: ITT

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

Outcome measures

Outcome measures
Measure	NDURE n=15 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Navigator Caseload	3.5 simultaneous cases Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Navigator Time Allocation (Direct)	96 minutes per patient Interval 90.0 to 135.0

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure.

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

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Navigator Time Allocation (Indirect)	135 minutes/patient Interval 120.0 to 195.0

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Navigator Time Allocation (Total)	231 minutes/patient Interval 210.0 to 330.0

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Percent of Patients With a Delay Starting Post-Operative Radiation Treatment	2 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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)

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
Percent Difference in PORT Delay Between White and Black Patients With Head and Neck Cancer	14.2 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Utility of Sessions With the Navigator	4.79 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Timeline of Activities	4.85 score on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Helpful in Identifying Challenges Starting Radiation Therapy	4.79 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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 coming up with a plan to solve my specific challenges starting radiation therapy after surgery." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Helpful in Coming up With a Plan to Solve Challenges Starting Radiation	4.85 score on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

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 solving my specific challenges starting radiation therapy after surgery." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Helpful in Solving Challenges Starting Radiation	4.69 score on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "he material that I received from the navigator was relevant in helping me address my challenges starting radiation therapy after surgery." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Material From Navigator Was Relevant	4.64 score on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The timing of the program starting at my surgical consultation (before surgery) worked well for me." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Timing of Program	4.85 score on a scale Standard Deviation 0.38

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The method of meeting with the navigator to ensure timely head and neck cancer care (face to face) worked well for me." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Method of Delivery	5.0 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their agreement with the following statement on a scale of 1-5: "The number of sessions with the navigator (at least 3) worked well for me." Higher scores represent higher levels of agreement.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Number of Sessions	4.43 score on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their satisfaction with the NDURE program on a scale of 1-5; higher scores represent higher levels of satisfaction.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Overall Satisfaction	4.92 score on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: 3 months

Population: ITT; 1 participant who suffered a mortality prior to the end of the study was not evaluable for this outcome measure

The study-specific program evaluation scale asks participants to rate their likelihood to recommend this program to someone else with head and neck cancer on a scale of 1-5; higher scores represent a greater likelihood of recommending NDURE.

Outcome measures

Outcome measures
Measure	NDURE n=14 Participants NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. NDURE: NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
NDURE Program Evaluation Scale Score: Likelihood to Recommend	4.79 score on a scale Standard Deviation 0.58

Adverse Events

NDURE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Evan M. Graboyes, MD, MPH (principal investigator)

Medical University of South Carolina

Phone: 843-792-0719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place