Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels.

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

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.

Design: The study design is a single-site, single-arm, trial of NDURE (Navigation for Disparities and Untimely Radiation thErapy) to assess the feasibility and acceptability of this patient navigation (PN) intervention to decrease delays and racial disparities starting postoperative radiation therapy (PORT) after surgery for HNSCC.

Following screening and informed consent, sociodemographic and oncologic will be prospectively gathered about participants from validated questionnaires and the electronic medical record (EMR). Participants will undergo 3 sessions of NDURE. Measures of feasibility (enrollment, dropout, missed PN encounters, navigator caseload, and time allocation) will be assessed during delivery of NDURE. Questionnaires assessing symptom burden and health-related beliefs will be collected at baseline and post-treatment to assess the feasibility of data collection procedures and monitor completion rates. Following completion of NDURE, patients with HNSCC will complete validated measures of acceptability related to satisfaction with PN. Post-NDURE qualitative work with patients and providers will help refine the intervention

Treatment Allocation: Participants will be enrolled into NDURE

Delivery of intervention: NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. 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. 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.

The sample size justification for this single-arm study is based on the primary feasibility endpoints of NDURE accrual and completion. In the randomized controlled trial (RCT) of NDURE (NCT04030130), the investigators plan to enroll 60% of eligible patients. The investigators expect similar accrual in this feasibility study and therefore, accruing to NDURE will be considered feasible if at least 15 of 25 eligible subjects enroll. Our sample size was selected to provide a small probability of having an observed accrual rate of at least 60% when the true accrual probability is actually less than 60%. For example, if the true accrual probability for our proposed design is 45% (35%), the probability of enrolling 15 or more of 25 eligible subjects is only 10% (1%). Additionally, the investigators target an NDURE completion rate ≥85%. That is to say, NDURE is feasible if at least 13 of the 15 subjects enrolled complete all three in-person NDURE sessions. Accordingly, the sample size for the single-arm study was selected to provide a small probability of having an observed completion rate of at least 85% when the true completion probability of the intervention is actually less than 85%. For example, if the true completion probability for our proposed design is 70% (60%), the probability that 13 or more of the 15 enrolled patients complete all three in-person NDURE sessions is 13% (3%). Therefore, the probability of falsely declaring NDURE feasible is reasonably controlled based on this sample size.

Statistical Methods of Analysis: This aim is descriptive, and the statistical analysis focuses on characterizing the feasibility and acceptability of NDURE. To examine patterns and characterize sociodemographic, oncologic, and symptom burden variables, the investigators will construct graphical displays and descriptive statistics (e.g. frequencies and percent for categorical variables and mean, median, standard deviation, and range for continuous variables). Feasibility measures for study accrual rate will evaluate the proportion and frequency of eligible patients who accrue (overall, white, and African American). Given its pilot nature, the study is not designed to evaluate racial differences in accrual, although reasons for study decline will be collected, analyzed for each racial subgroup, and used to refine recruitment. NDURE completion rate will be analyzed as 1) the percentage of enrolled patients who attend all three in-person NDURE sessions and 2) the proportion of three in-person NDURE sessions that are completed. For navigator caseload, the investigators will consider the frequency of simultaneous cases navigated. Navigator time allocation for direct and indirect time, as well as patient-report measures of satisfaction with navigation will be summarized as described above for continuous data. Study questionnaire completion rate will be calculated as the proportion of pre- and post-intervention questionnaires (n=5 each) completed. Qualitative data will be analyzed using established team codebooks and focus on the content, format, delivery, and timing of NDURE. Qualitative analysis of semi-structured interviews with patients and providers following the pilot will be analyzed using established codebooks from the study team for evaluating the feasibility and acceptability of clinic-based interventions with a focus on the content, format, delivery, and timing of NDURE.

Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC

Single-Arm Trial Assessing the Feasibility and Acceptability of Navigation for The Management of Delays and Racial Disparities Starting Adjuvant Therapy in Adults With Surgically-Managed, Locally Advanced HNSCC (NDURE 2.0 Pilot)

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

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

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).

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

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.

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

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

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.

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Medical University of South Carolina

Assistant Professor, Department of Otolaryngology-Head & Neck Surgery

This trial is considered to carry a low risk to subjects (i.e. has a "no more than minimal risk" designation). As such, this protocol defines an adverse event (AE) as any undesirable sign, symptom, medical, psychological, social, or emotional reaction that is definitely, probably, or possibly related to the study intervention.

NDURE is a navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT at the patient-, healthcare team-, and organization-levels. 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 patient 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. 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.

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

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Health Insurance Coverage

Marital Status

Living Situation

Highest Level of Education

Employment

Subsite

Patients were staged using the American Joint Committee on Cancer (AJCC) 8th Edition Staging Manual for Head and Neck Cancer. Pathologic T category is determined by pathologic evaluation of the main cancer specimen following surgery. Pathologic T category ranges from 0 to 4b, with higher AJCC T category representing more locally advanced head and neck cancer

American Joint Committee on Cancer Pathologic T Category

Patients were staged using the American Joint Committee on Cancer (AJCC) 8th Edition Staging Manual for Head and Neck Cancer. Pathologic N category is determined by pathologic evaluation of the lymph nodes from the neck dissection specimen following surgery. Pathologic N category ranges from 0 to 3b, with higher AJCC N category representing more regionally advanced head and neck cancer

American Joint Committee on Cancer Pathologic N Category

Patients were staged using the American Joint Committee on Cancer (AJCC) 8th Edition Staging Manual for Head and Neck Cancer. Overall AJCC Pathologic Stage Grouping is determined by combining the pathologic T, N, and M categories. Overall pathologic AJCC Stage Grouping ranges from 0 to IVc, with higher stage grouping representing more advanced head and neck cancer

Overall American Joint Committee on Cancer Stage Grouping

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

Adjuvant Therapy

Fragmentation of Care Between Surgical and Radiation Facilities

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

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

Percent of Eligible Participants Who Accrue to NDURE

Percent of Participants Who Complete the NDURE Intervention and Study Measures

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

Satisfaction With the Interpersonal Relationship With the Navigator (PSN-I) Scale Score

Navigator Caseload

Navigator Time Allocation (Direct)

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

Navigator Time Allocation (Indirect)

Navigator Time Allocation (Total)

Percent of Patients With a Delay Starting Post-Operative Radiation Treatment

Percent Difference in PORT Delay Between White and Black Patients With Head and Neck Cancer

NDURE Program Evaluation Scale Score: Utility of Sessions With the Navigator

NDURE Program Evaluation Scale Score: Timeline of Activities

NDURE Program Evaluation Scale Score: Helpful in Identifying Challenges Starting Radiation Therapy

NDURE Program Evaluation Scale Score: Helpful in Coming up With a Plan to Solve Challenges Starting Radiation

NDURE Program Evaluation Scale Score: Helpful in Solving Challenges Starting Radiation

NDURE Program Evaluation Scale Score: Material From Navigator Was Relevant

NDURE Program Evaluation Scale Score: Timing of Program

NDURE Program Evaluation Scale Score: Method of Delivery

NDURE Program Evaluation Scale Score: Number of Sessions

NDURE Program Evaluation Scale Score: Overall Satisfaction

NDURE Program Evaluation Scale Score: Likelihood to Recommend

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

NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model \[HBM\]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC 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 navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.

UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.

NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months).

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, parallel-group, randomized controlled trial of adults with surgically-managed, locally advanced HNSCC, will be randomized to NDURE versus usual care to assess the preliminary clinical impact of NDURE on delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the rate of PORT delay, racial disparities in the rate of PORT delay, and completion rate of key cancer care processes. Participants will also complete validated questionnaires at baseline and post-intervention to understand the theoretical constructs underlying 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 HNC surgery, thereby improving survival for patients with HNC, decreasing racial disparities in mortality, and developing new standards of clinical care.

Design: The study design is a Single-Site, Parallel-Group, Randomized-Controlled Trial of Navigation Versus Usual Care for The Management of Delays and Racial Disparities Starting Postoperative Radiation Therapy in Adults with Surgically-Managed, Locally Advanced Head and Neck Squamous Cell Carcinoma

Following screening and informed consent, sociodemographic, oncologic and symptom data will be prospectively gathered about participants from validated questionnaires and the electronic medical record (EMR). Participants will then be randomized to 3-sessions of the navigation intervention (NDURE; Navigation for Disparities and Untimely Radiation thErapy) or usual care (UC) and followed until the start of postoperative radiation therapy (PORT) following surgery for head and neck squamous cell carcinoma (HNSCC). Measures of PORT delay, racial disparities in PORT delay, key cancer care delivery processes, and theoretical constructs underlying PORT will be evaluated.

Treatment Allocation: Upon enrollment, participants will be randomized 1:1 to NDURE or UC using a stratified randomization design with strata defined by race (white, African American \[AA\]) and location of radiation facility (Medical University of South Carolina (\[MUSC\], non-MUSC) because of the known association of these variables with PORT delay.

Delivery of intervention:

NDURE is a theory-based, multi-level PN intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, increase HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The NDURE intervention consists of: Navigation Sessions, the Navigator Manual, the Navigator Patient Guide, structured EMR documentation, weekly conferences to facilitate care coordination, real-time patient tracking, and multidisciplinary reporting. The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions. Contact beyond the three prescribed in-person sessions will occur with a frequency and modality (e.g. text message, email, etc.) dictated by patient and navigator need. During the first in-person session, the navigator will 1) elicit barriers and facilitators to timely PORT from the patient, caregiver, and provider, 2) develop the personalized barrier reduction plan (BRP), review it with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent in-person 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. The Navigator Manual provides a structured resource to guide intervention delivery and enhance reproducibility. The Patient Guide is 1) literacy-level appropriate, 2) personalized for each patient's care pathway and BRP, 3) updated longitudinally as the patient progresses along the cancer continuum, and 4) available to patients in print and/or electronically via the patient portal in the EMR.

UC consists of oncology visits with provider-led discussion about the referrals needed to start PORT.

Expected Effect Size and Power Calculation: Power and sample size calculations were performed using PASS version 08.0.13, "Inequality Tests for Two Independent Proportions." The primary endpoint for this pilot RCT is the rate of PORT delay, defined by NCCN Guidelines as PORT initiation \> 6 weeks following surgery. Our primary objective is to compare PORT delay rates between the NDURE and UC arms. Patients (n=150) will be randomized 1:1 to NDURE or UC using a stratified randomization design with strata defined by race (white or AA) and location of radiation facility (MUSC or not MUSC). Furthermore, to facilitate evaluation of PORT delay rates in racial subgroups, the investigators will oversample AAs for a final sample size of 50 white and 25 AA patients in each arm. The investigators assume the rate of PORT delay in the usual care arm will be 45% and target an absolute reduction of 20% for a PORT delay in the navigation arm of 25%. This effect size is clinically significant and is a realistic goal given published rates of improvement in similar (non-randomized) interventions. Seventy-five patients in each arm yields 83% power to detect a 20% reduction in PORT delay (45% versus 25%) based on a two-sided Mantel-Haenszel test of two independent proportions assuming a two-sided α = 0.1. Our choice of the Mantel-Haenszel test to compare proportions is based on the trial's stratified design. Our selection of α = 0.1 and 1 - β = 0.8 is based on the desire to emphasize power over type I error at this early stage of development (single institution phase II trial) to ensure follow-up on promising interventions. The investigators therefore consider our trial to be appropriately and rigorously designed to detect a clinically meaningful reduction in PORT delay.

Statistical Methods of Analysis: Graphical displays and descriptive statistics for sociodemographic, oncologic, and baseline symptom severity characteristics will be used to examine patterns and summarize data for each arm. The percentage of patients who start PORT within 6 weeks of surgery (the primary outcome measure) and corresponding 95% confidence interval (CI) will be calculated for both arms and for white and AA subgroups within each arm separately. The rate of PORT delay will be compared between arms using a Mantel-Haenszel test of two proportions, with strata defined by race and location of radiation facility. The investigators will analyze time to PORT as a continuous variable and estimate median time to PORT for each arm and for racial subgroups within each arm using Kaplan-Meier curves with Greenwood variance estimation to construct the corresponding 95% CIs. The investigators will estimate the hazard ratio comparing the two arms using Cox proportional hazards regression controlling for the stratification variables. The investigators will compare time to PORT between intervention arms using a stratified log-rank test. For other secondary endpoints, data will be summarized using frequency and percent for categorical variables and using mean, median, standard deviation, IQR and range for continuous variables. The investigators will also construct 95% CIs to provide a measure of uncertainty in estimated proportions and means. Comparisons between trial arms of other secondary endpoints will be performed using t-tests and chi-square tests, or Wilcoxon rank sum and Fisher's exact tests as appropriate. Baseline and post-intervention values of variables measuring the theoretical constructs underlying NDURE (i.e. care coordination, self-efficacy in cancer care, interpersonal support, and knowledge) will be compared using Wilcoxon sign rank tests. Comparisons between arms of the change in scores will be conducted using Wilcoxon rank sum tests.

Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC

Parallel-Group, Randomized-Controlled Trial of Navigation Vs Usual Care for The Management of Delays and Racial Disparities Starting Adjuvant Therapy in Adults With Surgically-Managed, Locally Advanced HNSCC (NDURE 2.0)

Initiation of PORT \> 6 weeks after surgery

Time, in days, between the date of definitive surgical resection to the initiation of radiation therapy

The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log

The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log.

The measures assesses the performance (or lack thereof) of a care delivery process (Pre-Surigcal Radiation Consultation) for patients with HNSCC. The measure is evaluated as performed if the patient attends a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting

The measures assesses the performance (or lack thereof) of a care delivery process (Pre-Radiation Therapy Dental Extractions) for patients with HNSCC. The measure is evaluated as performed if the patient has extraction of his/her indicated teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.

The measures assesses the performance (or lack thereof) of a care delivery process (Surgery to Pathology Report \</= 7 days) for patients with HNSCC. The measure is evaluated as performed if the pathology report from the definitive surgical procedure is produced within the EMR within 7 calendar days of the definitive surgical procedure. Addenda to the pathology report at the request of the HNSCC team (e.g. tumor p16 status) are not counted in this measure.

The measures assesses the performance (or lack thereof) of a care delivery process (Surgery to PORT Referral \</= 10 days) for patients with HNSCC. The measure is evaluated as performed if the a referral for PORT is placed, at MUSC or elsewhere, within 10 calendar days of the definitive surgical procedure.

TThe measures assesses the performance (or lack thereof) of a care delivery process (Surgery to PORT Referral \</= 10 days) for patients with HNSCC. The measure is evaluated as performed if a patient is evaluated in consultation 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.

The measures assesses the performance (or lack thereof) of a care delivery process (RT Consult to Initiation \</= 21 days) for patients with HNSCC. The measure is evaluated as performed if PORT is initiated within 21 calendar days of the patient being evaluated by a radiation oncologist for PORT.

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

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

A modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNSCC surgery. Items are rated on a 5-point Likert scale with higher scores indicating higher perceived susceptibility

An easily modifiable measure of 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

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

A validated, psychometrically sound 12-item scale that addresses three domains of self-efficacy in cancer care (understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information). The CASE-Cancer scale has been used extensively in PN studies to measure perceived self-efficacy. Responses are on a 4-point Likert scale with higher scores indicating higher levels of self-efficacy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC	NCT04098458	Squamous Cell C...	NDURE	18 Years -	Medical University of South Carolina
Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC	NCT04030130	Squamous Cell C...	NDURE	18 Years -	Medical University of South Carolina
Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC	NCT04098458	Squamous Cell C...	NDURE	18 Years -	Medical University of South Carolina
Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC	NCT04030130	Squamous Cell C...	NDURE	18 Years -	Medical University of South Carolina

Spots Global Cancer Trial Database for ndure

Every month we try and update this database with for ndure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ndure

Every month we try and update this database with for ndure cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ndure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.