Navigation Intervention for Head and Neck Cancers
(ENDURE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ENDURE for head and neck cancers?
Is the Navigation Intervention for Head and Neck Cancers safe for humans?
How is the ENDURE treatment different from other treatments for head and neck cancers?
ENDURE is unique because it uses a navigation-based approach to ensure patients receive timely and guideline-adherent radiation therapy after surgery, which helps reduce delays and improve survival rates. This approach is particularly focused on addressing disparities in treatment access and outcomes.19101112
What is the purpose of this trial?
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?
Research Team
Evan M Graboyes, M.D.
Principal Investigator
Medical University of South Carolina
Eligibility Criteria
This trial is for adults over 18 with certain types of head and neck cancers, including oral and laryngeal cancers, who plan to have surgery but haven't had radiation therapy for these cancers before. They should be able to speak and write English and not have severe mental illness or another untreated cancer that affects life expectancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Surgical Consultation
Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC
Pre-Radiation Therapy Dental Extractions
The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC
Treatment
Initiation of postoperative radiation therapy (PORT) following definitive surgery for HNSCC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ENDURE
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
National Cancer Institute (NCI)
Collaborator