Not Yet RecruitingNot Applicable

Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)

United States24 participantsStarted 2026-02-01

Plain-language summary

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face significant delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple socioeconomic and systems-level barriers to accessing timely cancer care. Delays of more than 30 days have been associated with worse outcomes, including higher recurrence rates and reduced survival. This pilot study will evaluate the feasibility and early impact of a community-based navigation program designed to improve access to timely care for ED-presenting HNC patients. The study embeds trained Community Health Support Specialists (CHSS) from the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. After ED discharge, CHSS staff will contact participants by telephone or text message to identify barriers to care-such as transportation, insurance, housing, or communication challenges-and connect them with appropriate community or institutional resources. All participants will receive the CHSS navigation intervention. Outcomes will be compared with a historical cohort of similar ED-presenting HNC patients treated prior to program implementation. The primary outcomes are time from ED discharge to diagnostic biopsy and time from ED discharge to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS navigation, and exploratory analyses of the types of barriers identified and resolved. Findings from this pilot will generate preliminary data to inform larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age 18 years or older * Presentation to the emergency department (ED) with a new or suspected head and neck cancer (including oral cavity, oropharynx, hypopharynx, larynx, salivary gland, cutaneous, sinonasal, nasopharyngeal, thyroid, or metastatic disease with unknown primary) * Residence within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health) * Ability to provide informed consent electronically using REDCap eConsent after ED discharge * Has a valid telephone number for post-discharge contact Exclusion Criteria * Prior or ongoing established head and neck oncology care at the time of ED presentation * Currently receiving hospice or palliative-only care * Incarcerated individuals * Inability to complete electronic informed consent (e.g., lack of decisional capacity or inability to complete consent even with staff assistance) * Lacks reliable telephone access or is unable to be reached after three documented contact attempts by study staff * Non-English or non-Spanish speaking when interpreter services are unavailable * Expected survival less than four weeks, as determined by the treating clinical team

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)

Timeframe: Up to 90 days after ED discharge

Time From Emergency Department (ED) Presentation to Treatment Initiation (Days)

Timeframe: Up to 90 days after ED discharge

Trial details

NCT IDNCT07225725

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Justin M Soffer, MD

321-287-7574 jsoffer@uthsc.edu

View on ClinicalTrials.gov More Head and Neck Neoplasms trials