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

NCT07225725 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-22

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • Methodist University Hospital

    collaborator UNKNOWN
  • Regional One Health

    collaborator OTHER
  • UTHSC Center for Cancer Research

    collaborator UNKNOWN
  • University of Tennessee

    lead OTHER

Principal Investigators

  • David Schwartz, MD · University of Tennessee

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225725 on ClinicalTrials.gov