Recruiting

ENDURE vs. Treatment

Sponsor:

Medical University of South Carolina

Code:

NCT05793151

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Oropharynx Cancer

Oral Cavity Cancer

Larynx Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ENDURE

Study Details

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?

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Oropharynx Cancer

Oral Cavity Cancer

Larynx Cancer

Study ID

NCT05793151

Start date

Oct 30, 2023

Status verified date

Dec, 2025

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

532 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ENDURE

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

no intervention: Treatment As Usual

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

Interventions

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.

Primary outcome measure

  • Initiation of Timely PORT [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Evan M Graboyes, MD, MPH

843-792-0719graboyes@musc.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Evan Graboyes, M.D., MPH, FACS

(843) 792-0719graboyes@musc.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-11.