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临床试验/NCT07225725
NCT07225725尚未招募不适用

Community Health Support for Emergency Department-Presenting Head and Neck Cancer Patients: A Pilot to Improve Access to Timely Care

University of Tennessee4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
4
主要终点
Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)

研究概览

简要总结

Patients diagnosed with head and neck cancer (HNC) after presenting to an emergency department (ED) often face serious delays in diagnosis and treatment. These patients are frequently younger, underinsured, and experience multiple barriers to accessing timely cancer care. Delays of more than 30 days are associated with worse outcomes, including higher recurrence and lower survival.

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.

详细描述

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 newly suspected or newly diagnosed head and neck cancer (HNC) patients. The study will be conducted at three 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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • 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

排除标准

  • Prior or ongoing established head and neck oncology care at the time of ED presentation
  • 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

结局指标

主要结局

Time From Emergency Department (ED) Presentation to Diagnostic Biopsy (Days)

时间窗: Up to 90 days after ED presentation

Interval, measured in days, between the date of initial ED presentation and the date of diagnostic biopsy confirming head and neck cancer. This measure evaluates timeliness of diagnostic workup following ED presentation.

Time From Emergency Department (ED) Presentation to Treatment Initiation (Days)

时间窗: Up to 90 days after ED presentation

Interval, measured in days, between the date of initial ED presentation and the start date of definitive treatment (surgery, radiation, systemic therapy, or combined modality). This measure assesses time to initiation of therapy as a key marker of access to care.

次要结局

  • Feasibility of Community Health Support Specialist (CHSS) Navigation(Up to 90 days after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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