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NCT04030130 · ClinicalTrials.gov registry record · NA
Navigation vs Usual Care 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
- 176
- Enrollment target
NCT04030130 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 176 participants.
The verdict
NCT04030130, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 176 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, parallel-group, randomized controlled trial of adults with surgically-managed, locally advanced HNSCC, will be randomized to NDURE versus usual care to assess the preliminary clinical impact of NDURE on delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the rate of PORT delay, racial disparities in the rate of PORT delay, and completion rate of key cancer care processes. Participants will also complete validated questionnaires at baseline and post-intervention to understand the theoretical constructs underlying 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 HNC surgery, thereby improving survival for patients with HNC, decreasing racial disparities in mortality, and developing new standards of clinical care.
Interventions
- BEHAVIORAL NDURE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2020-05-19 |
| Est. Completion | 2024-01-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04030130
The ClinicalTrials.gov registry entry for NCT04030130 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NDURE is the first listed.
NCT04030130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04030130 about?
NCT04030130 is a clinical study titled "Navigation vs Usual Care 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 NCT04030130?
This trial is currently completed. It is a NA study. The enrollment target is 176 participants. The study started on 2020-05-19. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT04030130?
The interventions under investigation include: NDURE (BEHAVIORAL).
Who is sponsoring clinical trial NCT04030130?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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