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

NCT07225725 | Not Yet Recruiting

• 1 other identifier: 25-10971-XP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Head and Neck Neoplasms; Emergency Department Presentation; Head and Neck Cancer (H&N)

Keywords

Emergency Department; Patient Navigation; Community Health Support; Health Equity; Cancer Care Access; Care Timeliness; Implementation Science; Engaging Navigators to Reduce Inequities in Cancer Health; ENRICH Program; Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Feasibility of Community Health Support Specialist (CHSS) Navigation

  Up to 90 days after enrollment

Other Outcomes (2)

• Number and Types of Social Barriers Identified During CHSS Encounters

  Up to 90 days after enrollment

• Number of Barriers Resolved Through CHSS Intervention

  Up to 90 days after enrollment

Study Arms (1)

Community Health Support Specialist (CHSS) Navigation

EXPERIMENTAL

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

Interventions

Community Health Support Specialist (CHSS) Navigation BEHAVIORAL

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.

Community Health Support Specialist (CHSS) Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• Methodist University Hospital: collaborator
• Regional One Health: collaborator
• UTHSC Center for Cancer Research: collaborator

Study Sites (2)

Methodist University Hospital

Orlando, Florida, 32819, United States

Location

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Related 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.

MeSH Terms

Conditions

Head and Neck Neoplasms; Emergencies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Schwartz, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin M Soffer, MD

CONTACT

321-287-7574; jsoffer@uthsc.edu

David Schwartz, MD

CONTACT

516-234-8090; dschwar4@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective feasibility pilot evaluating structured Community Health Support Specialist (CHSS) navigation initiated after emergency department discharge for adults presenting to the ED with suspected or newly diagnosed head and neck cancer.

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)