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Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy — ENDURE  

Head and Neck Cancer Clinical Trial

Official title:
A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Decrease Delays Starting Postoperative Radiation Therapy in Adults With Head and Neck Cancer

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual at decreasing delays starting guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: - Does ENDURE decrease delays starting PORT relative to treatment as usual? - Does ENDURE decrease racial disparities in delays starting PORT relative to treatment as usual - What are the mechanisms through which ENDURE reduces treatment delays?

Clinical Trial Description

In this hybrid type 1 effectiveness-implementation study, the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers (n=4; 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with head and neck cancer undergoing surgery and postoperative radiation therapy (PORT). The trial will assess the effect of ENDURE vs TAU on delays starting PORT (primary objective), racial disparities in PORT delay (secondary objective), and the underlying mechanisms of ENDURE (secondary objective). The investigators will concurrently conduct a mixed-methods study with quantitative measures of implementation outcomes and qualitative data about implementation determinants from semi-structured interviews with key stakeholders and site visits (exploratory objective). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05793151
Study type Interventional
Source Medical University of South Carolina
Contact Evan M Graboyes, MD, MPH
Phone 843-792-0719
Email graboyes@musc.edu
Status Recruiting
Phase N/A
Start date October 30, 2023
Completion date March 30, 2028
View Details
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