Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05793151
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDURE
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?
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?
Detailed 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 improving initiation of timely PORT (primary 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA282165 | NIH | None | https://reporter.nih.gov/quic… | View |