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

Description

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual 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: * Does ENDURE improve initiation of timely PORT relative to treatment as usual? * Does ENDURE improve initiation of timely PORT in regards to racial disparities relative to treatment as usual? * What are the mechanisms through which ENDURE improves timeliness to treatment?

Conditions

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

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual 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: * Does ENDURE improve initiation of timely PORT relative to treatment as usual? * Does ENDURE improve initiation of timely PORT in regards to racial disparities relative to treatment as usual? * What are the mechanisms through which ENDURE improves timeliness to treatment?

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

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

Condition
Head and Neck Cancer
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary.
  • 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings.Plan to undergo surgery at a participating site
  • 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).
  • 1. Inability to speak or read English.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Evan M Graboyes, MD, MPH, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2028-03-30