Actively Recruiting
A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer
Led by Medical University of South Carolina · Updated on 2025-12-11
532
Participants Needed
4
Research Sites
N/A
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
Researchers are evaluating a navigation-based multilevel intervention called ENDURE compared with treatment as usual to improve timely start of postoperative radiation therapy (PORT) in patients with head and neck cancer. This study is a hybrid type 1 effectiveness-implementation trial designed to answer if ENDURE improves initiation of PORT, understand how it works, and explore how it can be integrated into routine care. The trial involves patients with specific types and stages of squamous cell carcinoma undergoing surgery and radiation therapy. The study uses a stepped-wedge cluster randomized design across four cancer centers, where patients first receive treatment as usual and then the ENDURE intervention. ENDURE aims to overcome barriers by providing patient education, social support, coordinated communication among cancer care teams, and referral tracking. It enhances standard patient navigation focusing on key transitions in care from diagnosis, surgery, and radiation oncology. Treatment as usual involves standard clinical care practices at each site. Participants will be monitored for the timing of starting PORT within three months after surgery as the primary outcome. Secondary outcomes include time to PORT, pre-surgical consultations, dental extractions before radiation, and scheduling and attendance for radiation oncology appointments. Researchers will collect quantitative and qualitative data to evaluate both effectiveness and implementation. The study runs from October 2023 to March 2028, with multiple assessments and interviews conducted throughout.
CONDITIONS
Brief 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 its variants in oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
- Clinical stage T3-4 or greater than N1 according to AJCC 8th edition for the specified cancer sites
- No prior radiation therapy for head and neck squamous cell carcinoma that affects need for adjuvant radiation
- Planned curative surgery at a participating center
- Planned postoperative radiation therapy with or without chemotherapy based on expected adverse features on final pathology such as pT3 or pT4 primary, 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 oropharyngeal cancer or unknown primary staged as cT1-2N1 with a single lymph node less than 3 cm
- Untreated synchronous malignancy expected to affect life expectancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 month
Participants undergo surgery for head and neck cancer followed by immediate post-operative care.
Visits as needed during hospital stay and initial recovery
Duration - Up to 3 months
Participants receive either the ENDURE navigation-based intervention or treatment as usual to support timely initiation of postoperative radiation therapy.
Multiple visits coordinated for care transitions and radiation therapy initiation
Duration - Up to 4 months
Participants are followed to monitor initiation and timing of postoperative radiation therapy and related care coordination.
Follow-up visits with oncology and radiation teams
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here