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

Not Applicable

Recruiting

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

• Registration Number: NCT05793151
• Lead Sponsor: Medical University of South Carolina

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?

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 Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Study Start: 2023-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2028-03-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

1. Age >/= 18 years
2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or >/= N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary
4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT
5. Plan for curative intent surgery at one of the participating centers
6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI).

Exclusion Criteria

1. Inability to speak or read English or Spanish.
2. Severe mental illness that would prevent trial participation.
3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
4. Synchronous untreated malignancy expected to impact life expectancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Initiation of Timely PORT	3 months	The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC.

Secondary Outcome Measures

Name	Time	Method
Time-to-PORT	4 months	The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.
Pre-radiation therapy dental extractions	1 month	The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC.
Pre-Surgical consultation with radiation oncology	1 month	Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC.
Time to postoperative scheduling with radiation oncology	3 months	The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist.
Time to postoperative appointment with radiation oncology	3 months	Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist.

Trial Locations

Locations (4)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States