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NCT Number: NCT05793151

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

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?

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cavity Cancer Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 18 years
  • Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
  • 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.
  • 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.
  • Plan for curative intent surgery at one of the participating centers
  • 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

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

Treatment and study plan

ENDURE

Behavioral

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.

Primary outcomes

  1. Initiation of Timely PORT

    Time frame: 3 months

    The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC.

Secondary outcomes

  1. Time-to-PORT

    Time frame: 4 months

    The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.

  2. Pre-Surgical consultation with radiation oncology

    Time frame: 1 month

    Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC.

  3. Pre-radiation therapy dental extractions

    Time frame: 1 month

    The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC.

  4. Time to postoperative scheduling with radiation oncology

    Time frame: 3 months

    The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist.

  5. Time to postoperative appointment with radiation oncology

    Time frame: 3 months

    Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist.

Study contacts

Contact information is provided by the study sponsor or research team.

Evan M Graboyes, MD, MPH

CONTACT

[email protected]

843-792-0719

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ENDURE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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