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

Medical University of South Carolina (MUSC)

Status: Enrolling

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

Treatments: Behavioral: ENDURE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05793151

R01CA282165 (U.S. NIH Grant/Contract)

Pro00123953

Details and patient eligibility

About

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?

Full 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).

Enrollment: 532 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

532 participants in 2 patient groups

ENDURE

Experimental group

Description:

ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT.

Treatment:

Behavioral: ENDURE

Treatment As Usual

No Intervention group

Description:

Treatment as usual at each site consists of standard of care clinical practices