NCT05793151 Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
| NCT ID | NCT05793151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 532 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 532 participants in total. It began in 2023-10-30 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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?
Eligibility Criteria
Inclusion Criteria: 1. Age \>/= 18 years 2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity 3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \>N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary. 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT. 5. Plan for curative intent surgery at one of the participating centers 6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI). Exclusion Criteria: 1. Inability to speak or read English or Spanish. 2. Severe mental illness that would prevent trial participation. 3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \< 3 cm 4. Synchronous untreated malignancy expected to impact life expectancy
Contact & Investigator
Evan M Graboyes, MD, MPH
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05793151 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05793151 currently recruiting?
Yes, NCT05793151 is actively recruiting participants. Contact the research team at graboyes@musc.edu for enrollment information.
Where is the NCT05793151 trial being conducted?
This trial is being conducted at St Louis, United States, Durham, United States, Charleston, United States, Houston, United States.
Who is sponsoring the NCT05793151 clinical trial?
NCT05793151 is sponsored by Medical University of South Carolina. The principal investigator is Evan M Graboyes, MD, MPH at Medical University of South Carolina. The trial plans to enroll 532 participants.
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