Actively Recruiting
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
Led by Medical University of South Carolina · Updated on 2025-12-11
532
Participants Needed
4
Research Sites
230 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: 1. Does ENDURE improve initiation of timely PORT relative to treatment as usual? 2. What are the mechanisms through which ENDURE improves timeliness to treatment? 3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?
CONDITIONS
Official Title
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with squamous cell carcinoma or histologic variant in the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
- Clinical stage T3-4 or greater than N1 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary, according to AJCC 8th edition
- No prior radiation therapy for head and neck squamous cell carcinoma that affects the need for adjuvant radiation therapy
- Planned curative surgery at a participating center
- Planned postoperative radiation therapy with or without chemotherapy after surgery due to high-risk features such as pT3 or pT4 primary tumor, N1 or greater nodal disease, perineural invasion, or lymphovascular invasion
You will not qualify if you...
- Unable to speak or read English or Spanish
- Severe mental illness preventing participation
- HPV-positive oropharynx cancer or unknown primary squamous cell carcinoma staged as cT1-2N1 with a single ipsilateral lymph node smaller than 3 cm
- Having another untreated cancer expected to affect life expectancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
4
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Evan M Graboyes, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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