Head and Neck NeoplasmsENRICH-HNCNCT07225725
Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)
A study testing Community Health Support Specialist (CHSS) Navigation in people with Head and Neck Neoplasms and Emergency Department Presentation, run by University of Tennessee at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Emergency Department Presentation, Head and Neck Cancer (H&N)
- What is being tested?
- Community Health Support Specialist (CHSS) Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Regional One Health
Memphis, Tennessee, 38103
Justin M Soffer, MD, 321-287-7574
Methodist University Hospital
Orlando, Florida, 32819
Justin M Soffer, MD, 321-287-7574, jsoffer@uthsc.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Community Health Support Specialist (CHSS) Navigation
- 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
- Medical subject headings
- Head and Neck Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Support Specialist (CHSS) NavigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Health Support Specialist (CHSS) Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist University Hospital, Regional One Health, UTHSC Center for Cancer Research
- Responsible party
- Sponsor
- Investigators
- David Schwartz, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225725
- Sponsor's protocol ID
- 25-10971-XP
- Acronym
- ENRICH-HNC
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care
- ClinicalTrials.gov ID
- NCT07225725
- Acronym / sponsor ID
- ENRICH-HNC / 25-10971-XP
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Methodist University Hospital, Regional One Health, UTHSC Center for Cancer Research
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Community Health Support Specialist (CHSS) Navigation | Experimental | Behavioral: Community Health Support Specialist (CHSS) NavigationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Support Specialist (CHSS) NavigationThis 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. | Behavioural | Community Health Support Specialist (CHSS) Navigation |
Primary outcome
Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)
Time frame: Up to 90 days after ED discharge
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 From Emergency Department (ED) Presentation to Treatment Initiation (Days)
Time frame: Up to 90 days after ED discharge
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.
1 secondary outcome
Feasibility of Community Health Support Specialist (CHSS) Navigation
Time frame: Up to 90 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- 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.Link provided by the sponsor.
- Official UTHSC Cancer Center webpage providing information about cancer research, pilot grant programs, and access-to-care initiatives supported by the institution.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Schwartz, MD principal investigator
University of Tennessee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Support Specialist (CHSS) Navigation in people with Head and Neck Neoplasms and Emergency Department Presentation, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin M Soffer, MD (321-287-7574, jsoffer@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days) (time frame: Up to 90 days after ED discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.