Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793151
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-03-20
Brief Title:
Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
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 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
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
Detailed Description:
In this hybrid type 1 effectiveness-implementation study the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers n4 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 Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA282165 | NIH | None | httpsreporternihgovquickSearchR01CA282165 |