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NCT04098458 · ClinicalTrials.gov registry record · NA
Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT04098458: Completed NA study, sponsored by Medical University of South Carolina.
NCT04098458 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04098458, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, single-arm trial, adults with surgically-managed, locally advanced HNSCC, will be enrolled in NDURE to assess the feasibility and acceptability of NDURE as a novel approach to decreasing delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the accrual rate and NDURE completion rate. Participants will also complete validated questionnaires at baseline and post-intervention to evaluate the feasibility of outcome assessment for NDURE. Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNSCC surgery, thereby improving survival for patients with HNSCC, decreasing racial disparities in mortality, and developing new standards of clinical care.
Primary Outcome
Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria
Interventions
- BEHAVIORAL NDURE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2020-04-14 |
| Phase | NA |
What the finished NCT04098458 record still lists
NCT04098458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which NDURE is the first listed.
NCT04098458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04098458 about?
NCT04098458 is a clinical study titled "Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC". Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mo...
What is the current status of trial NCT04098458?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2019-09-12. Estimated completion is 2020-04-14.
What interventions are being tested in trial NCT04098458?
The interventions under investigation include: NDURE (BEHAVIORAL).
Who is sponsoring clinical trial NCT04098458?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04098458's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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