NCT05793151

Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

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).

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma
• Oropharynx Cancer
• Oral Cavity Cancer
• Larynx Cancer

Interventions

Type	Name	Description
BEHAVIORAL	ENDURE	ENDURE provides patient education through the ENDURE Patient Resource Guide and social support by linking patients to community resources (patient-level), standardizes discussions about expectations for PORT and clinical documentation to enhance communication and care coordination within and across interprofessional cancer teams (team-level), and implements referral tracking across fragmented health systems (organization-level). To facilitate care coordination, ENDURE modifies existing standard of care patient navigation (an evidence-based intervention that addresses barriers to timely cancer care) by adding PORT-focused navigation at three key care transitions: into the cancer care system; from inpatient to outpatient after surgery; and from the surgical team to the radiation oncology team.

Timeline

• Start date: 2023-10-30
• Primary completion: 2028-03-30
• Completion: 2028-03-30
• First posted: 2023-03-31
• Last updated: 2025-12-11

Locations

4 sites across 1 country: United States