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

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Squamous Cell Carcinoma of Head and Neck (SCCHN)

• Registration Number: NCT07225725
• Lead Sponsor: University of Tennessee

Brief Summary

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face serious delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple barriers to accessing timely cancer care. Delays of more than 30 days are associated with worse outcomes, including higher recurrence and lower survival.

This pilot study will test 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 will embed trained Community Health Support Specialists (CHSS) from the existing Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program into the ED-to-treatment pathway. Within 72 hours of ED discharge, CHSS staff will contact participants by phone or text to identify barriers to care-such as transportation, insurance, or communication issues-and connect them with appropriate community or institutional resources.

All participants will receive the CHSS support intervention. Outcomes will be compared with a historical cohort of similar patients seen before program implementation. The main outcomes are the time from ED presentation to diagnostic biopsy and the time from ED presentation to treatment initiation. Secondary outcomes include feasibility, measured as the proportion of participants who complete CHSS support, and exploratory analysis of the types of barriers identified and resolved.

Findings will generate early data to guide larger studies aimed at improving access, reducing disparities, and accelerating treatment for head and neck cancer patients who first present in the emergency setting.

Detailed Description

This is a single-arm, prospective pilot study evaluating the feasibility and process impact of embedding Community Health Support Specialist (CHSS) navigation within the emergency department (ED)-to-treatment pathway for newly suspected or newly diagnosed head and neck cancer (HNC) patients. The study will be conducted at three UTHSC-affiliated hospitals: Methodist University Hospital and Regional One Health.

Eligible participants are adults aged 18 years or older who present to the ED with a new or suspected HNC involving the oral cavity, oropharynx, hypopharynx, larynx, salivary glands, skin, sinonasal region, nasopharynx, thyroid, or an unknown primary. Patients who have already established oncology care, are in hospice, incarcerated, or cannot be contacted by phone will be excluded.

After screening and verbal consent, CHSS specialists will initiate contact with each participant within 72 hours of ED discharge. The CHSS will provide structured, non-clinical support through at least two phone or text contacts before the start of definitive cancer treatment. Each contact will document barriers, interventions, and resolution status using standardized REDCap case report forms. Typical support activities include arranging transportation referrals, assisting with insurance verification or enrollment, connecting patients to housing or community resources, and reinforcing communication between patients and provider offices. CHSS staff will not provide clinical advice, make appointments, or alter treatment plans.

The primary outcomes are (1) the interval from ED presentation to diagnostic biopsy and (2) the interval from ED presentation to initiation of definitive treatment. Secondary outcomes include feasibility, measured as the proportion of enrolled participants completing CHSS navigation. Exploratory outcomes describe types of social barriers identified, barriers resolved, and overall navigation patterns.

Data will be entered and stored in REDCap, a secure, HIPAA-compliant database hosted by the University of Tennessee Health Science Center (UTHSC). Analyses will compare outcomes for the pilot cohort with a historical control group of similar ED-presenting HNC patients treated at UTHSC-affiliated hospitals in the 24 months preceding implementation. Non-parametric and regression analyses will estimate effect sizes and feasibility parameters to guide future multi-site implementation studies.

The study is funded through the UTHSC Cancer Center's Access to Cancer Care Pilot Project and builds upon the Tennessee Department of Health-supported ENRICH program, which employs CHSS specialists to reduce disparities in cancer care. This pilot will provide preliminary evidence to support scaling the ENRICH model statewide to improve equity, timeliness, and outcomes for head and neck cancer patients.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-04
• Study First Submitted QC: 2025-11-04
• Last Update Submitted: 2025-11-04
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2026-01-01
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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)
• Resident within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health)
• Able to provide verbal consent or have a caregiver available to provide consent on behalf of the patient
• Has a valid phone number for follow-up 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 or otherwise unable to provide voluntary consent
• Lacks phone access or unable to be reached after three attempts by CHSS staff
• Non-English or non-Spanish speaking without interpreter availability
• Expected survival less than 4 weeks as determined by the treating team

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)	Up to 90 days after ED presentation	Interval, measured in days, between the date of initial ED presentation and the date of diagnostic biopsy confirming head and neck cancer. This measure evaluates timeliness of diagnostic workup following ED presentation.
Time From Emergency Department (ED) Presentation to Treatment Initiation (Days)	Up to 90 days after ED presentation	Interval, measured in days, between the date of initial ED presentation and the start date of definitive treatment (surgery, radiation, systemic therapy, or combined modality). This measure assesses time to initiation of therapy as a key marker of access to care.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Community Health Support Specialist (CHSS) Navigation	Up to 90 days after enrollment	Proportion of enrolled participants who complete the full CHSS navigation protocol, defined as at least two successful CHSS contacts before treatment initiation. Feasibility will be reported as a percentage of total participants enrolled.

Trial Locations

Locations (2)

Methodist University Hospital; 🇺🇸 Orlando, Florida, United States

Regional One Health; 🇺🇸 Memphis, Tennessee, United States