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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Tennessee

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Community Health Support Specialist (CHSS) NavigationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 90 days after ED discharge
2

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.

Time frame
Up to 90 days after ED discharge

Secondary outcomes

1

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.

Time frame
Up to 90 days after enrollment

Other outcomes

1

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.

Time frame
Up to 90 days after enrollment
2

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.

Time frame
Up to 90 days after enrollment

Sponsors and contacts

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University of Tennessee

Lead sponsor

Methodist University Hospital

Collaborator

Regional One Health

Collaborator

UTHSC Center for Cancer Research

Collaborator

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