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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 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 18 participants.

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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.

Interventions

  • BEHAVIORAL NDURE

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-09-12
Est. Completion 2020-04-14
Phase NA

What the Registry Record Tells You About NCT04098458

The ClinicalTrials.gov registry entry for NCT04098458 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 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.

NCT04098458 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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