Patient Navigation Program for the Management of Delays and Racial Disparities to Starting Post-Operative Radiation Therapy in Patients with Stage III-IV Head and Neck Squamous Cell Carcinoma, the NDURE 2.0 Study

Inclusion Criteria

• Age >= 18 years at the time of screening
• Self-identified white or AA race
• Cytologically or pathologically confirmed SCC (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity. * In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but the patient is scheduled to undergo curative intent surgery by the treating oncologic surgeon due to clinical suspicion of invasive SCC, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the pathologic diagnosis enrollment criterion
• 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 * At screening, AJCC clinical stage grouping should be determined based on a combination of physical exam, diagnostic evaluation with cross sectional imaging of the neck (computerized tomography [CT] and/or magnetic resonance imaging [MRI]) and/or fludeoxyglucose F-18 (18-F-fluoro-deoxyglucose) positron emission tomography (FDG PET) CT within 60 days * In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia (without definitive evidence of invasive SCC), but would otherwise have an appropriate clinical stage grouping, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to full the staging enrollment criterion
• No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
• SURGERY AND ADJUVANT THERAPY ELIGIBILITY
• Plan for curative intent surgery at Medical University of South Carolina (MUSC) * At screening, plan for curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon
• Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery * At screening, plan for adjuvant therapy following curative intent surgical resection of the HNSCC at MUSC must be deemed likely by the treating surgeon and/or multidisciplinary tumor board, which must include a fellowship-trained head and neck oncologic surgeon, based on the clinical expectation of at least one of the following adverse features on final pathologic evaluation: extranodal extension (ENE), pT3 or pT4 primary, N1 or greater nodal disease, nodal disease in levels IV or V, perineural invasion (PNI), or lymphovascular invasion (LVI)

Exclusion Criteria

• Self-identified Hispanic ethnicity
• Presence of cognitive impairment that precludes participation
• Synchronous untreated malignancy * Patients with known untreated indolent malignancies (e.g. non-melanoma skin cancer, untreated chronic lymphocytic leukemia [CLL], thyroid gland papillary microcarcinoma [microPTC], untreated prostate cancer) at the time of diagnosis or that develop during the study period would not exclude a patient from the study