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

Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study

This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer patients.

This study will evaluate the feasibility, acceptability, preliminary clinical impact, and preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white and African American (AA) HNC patients and decrease disparities in delay between the two groups by improving system-, interpersonal-, and individual-level health behavior constructs.

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age > 18 years at the time of screening
2. Histologically or pathologically confirmed invasive squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity.
3. American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity; or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary.
4. No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
5. Plan for curative intent surgery at MUSC
6. Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Self-identified Hispanic ethnicity
2. Presence of cognitive impairment that precludes participation as determined by oncology provider
3. Prior radiation therapy for HNC
4. Failure to undergo curative intent surgery at MUSC
5. Lack of indication for PORT (with or without concurrent chemotherapy) per National Comprehensive Cancer Network (NCCN) Guidelines based on final pathologic evaluation of adverse features and AJCC pathologic stage grouping