Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)
NCT ID: NCT07225725
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2026-01-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Community Health Support Specialist (CHSS) Navigation
Participants will receive structured, non-clinical support from a trained Community Health Support Specialist (CHSS) through phone or text outreach after discharge from the emergency department. Contacts will focus on identifying social and logistical barriers to cancer care, providing resource referrals, and communicating with provider offices as needed. Each participant will receive at least two CHSS contacts before treatment initiation.
Community Health Support Specialist (CHSS) Navigation
The CHSS Navigation intervention consists of structured post-discharge outreach by trained Community Health Support Specialists affiliated with the ENRICH program. Within 72 hours of emergency department discharge, CHSS staff contact participants by phone or text to identify barriers such as transportation, insurance, or communication challenges. They provide referrals, resource coordination, and emotional support but do not deliver clinical care or alter treatment plans. All activities are documented in REDCap case report forms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Community Health Support Specialist (CHSS) Navigation
The CHSS Navigation intervention consists of structured post-discharge outreach by trained Community Health Support Specialists affiliated with the ENRICH program. Within 72 hours of emergency department discharge, CHSS staff contact participants by phone or text to identify barriers such as transportation, insurance, or communication challenges. They provide referrals, resource coordination, and emotional support but do not deliver clinical care or alter treatment plans. All activities are documented in REDCap case report forms.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Methodist University Hospital
UNKNOWN
Regional One Health
OTHER
UTHSC Cancer Center
UNKNOWN
University of Tennessee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Methodist University Hospital
Orlando, Florida, United States
Regional One Health
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Justin M Soffer, MD
Role: primary
Justin M Soffer, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
25-10971-XP
Identifier Type: -
Identifier Source: org_study_id