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

Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Neoplasms; Head and Neck Cancer (H&N); Emergency Department Presentation
• Intervention / Treatment: Behavioral: Community Health Support Specialist (CHSS) Navigation

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 patients with newly suspected or newly diagnosed head and neck cancer (HNC). The study will be conducted at two University of Tennessee Health Science Center (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 with prior established oncology care for HNC, those enrolled in hospice, incarcerated individuals, or patients who cannot be contacted by telephone will be excluded.

During routine clinical care in the ED, otolaryngology residents identify potentially eligible patients and introduce the study using an IRB-approved consent disclosure statement. ED activities are limited to screening and obtaining permission to contact; no informed consent or HIPAA authorization occurs in the ED.

After ED discharge, a trained study team member conducts the full informed consent process electronically using REDCap eConsent. Participants may review the consent form remotely with study staff and provide electronic signature with date/time acknowledgment. Only participants who complete electronic informed consent and HIPAA authorization are enrolled.

Following enrollment, CHSS specialists initiate outreach within 72 hours of ED discharge and provide structured, non-clinical navigation support through at least two telephone or text-based contacts prior to initiation of definitive cancer treatment. CHSS activities focus on identifying and addressing barriers to care, including transportation challenges, insurance or financial barriers, housing instability, and communication gaps. CHSS staff do not provide medical advice, schedule clinical appointments, or alter treatment plans. All encounters are documented using standardized REDCap case report forms.

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

Study data are entered and stored in REDCap, a secure, HIPAA-compliant database hosted by UTHSC. Outcomes for the pilot cohort will be compared with a historical control group of similar ED-presenting HNC patients treated at UTHSC-affiliated hospitals in the 24 months preceding program implementation. Analyses will use descriptive, non-parametric, and regression methods to estimate feasibility metrics and effect sizes to inform future multi-site studies.

This 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 deploys CHSS specialists to reduce disparities in cancer care. Results will inform potential expansion of this navigation model to improve equity, timeliness, and outcomes for head and neck cancer patients presenting through the emergency department.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin M Soffer, MD; Phone Number: 321-287-7574; Email: jsoffer@uthsc.edu
• Study Contact Backup: Name: David Schwartz, MD; Phone Number: 516-234-8090; Email: dschwar4@uthsc.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32819
      • Methodist University Hospital
      • Contact: Justin M Soffer, MD; Phone Number: 321-287-7574; Email: jsoffer@uthsc.edu
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Regional One Health
      • Contact: Justin M Soffer, MD; Phone Number: 321-287-7574

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Community Health Support Specialist (CHSS) Navigation; Participants will receive structured, non-clinical navigation support from a trained Community Health Support Specialist (CHSS) initiated after emergency department discharge. CHSS outreach will occur by telephone or text message and will focus on identifying social and logistical barriers to timely cancer care (e.g., transportation, insurance, housing, communication), providing appropriate resource referrals, and reinforcing communication between patients and clinical care teams as needed. Each participant will receive a minimum of two CHSS contacts prior to initiation of definitive cancer treatment.

Behavioral: Community Health Support Specialist (CHSS) Navigation; This intervention consists of structured, non-clinical navigation delivered by trained Community Health Support Specialists (CHSS) as part of the Engaging Navigators to Reduce Inequities in Cancer Health (ENRICH) program. Following emergency department discharge and completion of electronic informed consent, CHSS staff conduct outreach by telephone or text message to identify and address social and logistical barriers to timely head and neck cancer care. Navigation activities may include assistance with transportation resources, insurance or financial navigation, connection to housing or community services, and reinforcement of communication between patients and clinical care teams. CHSS staff do not provide medical advice, schedule clinical appointments, or alter treatment plans. All navigation encounters are documented using standardized REDCap instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)	Interval (days) between the date of ED discharge from the index visit and the date of the first diagnostic biopsy procedure performed to evaluate suspected head and neck cancer.	Up to 90 days after ED discharge
Time From Emergency Department (ED) Presentation to Treatment Initiation (Days)	Interval (days) between the date of ED discharge from the index visit and the start date of definitive treatment (surgery, radiation, systemic therapy, or combined modality) for head and neck cancer.	Up to 90 days after ED discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Community Health Support Specialist (CHSS) Navigation	Proportion of enrolled participants who complete the CHSS navigation protocol, defined as documentation of at least two completed CHSS outreach contacts (telephone or text message) prior to initiation of definitive treatment or study completion.	Up to 90 days after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Types of Social Barriers Identified During CHSS Encounters	Count and categorization of distinct social or logistical barriers (e.g., transportation, insurance, housing, communication) documented by CHSS staff across all encounters using standardized REDCap instruments.	Up to 90 days after enrollment
Number of Barriers Resolved Through CHSS Intervention	Count of barriers documented as resolved by CHSS staff using standardized REDCap instruments. Resolution is defined as documentation that the participant was successfully linked to an appropriate resource/service or that the identified barrier was otherwise addressed.	Up to 90 days after enrollment

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Regional One Health; Methodist University Hospital; UTHSC Center for Cancer Research
• Investigators: Principal Investigator: David Schwartz, MD, University of Tennessee

Publications and helpful links

Helpful Links

• UTHSC news release describing the ENRICH program, a state-funded initiative led by Drs. Schwartz and Stewart to improve cancer care access through community health support specialists in West Tennessee.
• Official UTHSC Cancer Center webpage providing information about cancer research, pilot grant programs, and access-to-care initiatives supported by the institution.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 4, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Emergency Department; Patient Navigation; Implementation Science; Health Equity; Community Health Support; Cancer Care Access; Care Timeliness; Engaging Navigators to Reduce Inequities in Cancer Health; ENRICH Program
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Head and Neck Neoplasms
• Other Study ID Numbers: 25-10971-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because this is a small, minimal-risk feasibility study containing identifiable clinical data. Aggregate results may be shared in publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No