Spots Global Cancer Trial Database for Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy

Study Description

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?

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 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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