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

Study acronym: ENRICH-HNC
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Jan 1, 2026 to Feb 1, 2026v2 Show 6 more changesShow less
    • Primary completion date: Oct 31, 2026 to Jan 31, 2027
    • Study completion date: Dec 31, 2026 to Jan 31, 2027
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 87 words
    • Collaborators revised (3)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07225725
Lead Sponsor University of Tennessee
Collaborators: Methodist University Hospital, Regional One Health, UTHSC Center for Cancer Research
Conditions
(from sponsor)		 Head and Neck Neoplasms, Emergency Department Presentation, Head and Neck Cancer (H&N)
Related terms Emergencies, Head and Neck Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov