Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
ENDURE
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
2 other identifiers
interventional
532
1 country
4
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Oct 2023
Typical duration for not_applicable head-and-neck-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
December 11, 2025
December 1, 2025
4.4 years
March 20, 2023
December 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Initiation of Timely PORT
The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC.
3 months
Secondary Outcomes (5)
Time-to-PORT
4 months
Pre-Surgical consultation with radiation oncology
1 month
Pre-radiation therapy dental extractions
1 month
Time to postoperative scheduling with radiation oncology
3 months
Time to postoperative appointment with radiation oncology
3 months
Study Arms (2)
ENDURE
EXPERIMENTALENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT.
Treatment As Usual
NO INTERVENTIONTreatment as usual at each site consists of standard of care clinical practices
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan M Graboyes, MD, MPH
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor-Faculty
Study Record Dates
First Submitted
March 20, 2023
First Posted
March 31, 2023
Study Start
October 30, 2023
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2028
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be shared no later than the time of a publication of findings of the trial's primary endpoint in a peer-reviewed journal.
- Access Criteria
- All data sharing will comply with privacy and confidentiality protections such as the NIH Certificate of Confidentiality and applicable laws, regulations, and policies governing data derived from human participants.
Below are the key elements of the data sharing plan as outlined in the NIH Policy for Data Management and Sharing: Research materials will include: (1) self-report measures from patients; (2) clinical data from the electronic medical record; (3) audio recordings and transcriptions of interviews from stakeholders; and (4) field notes from direct observations of the delivery of ENDURE at each site. Data will be raw or minimally processed. The investigators plan to use REDCap for data capture and management of the clinical and self-report measure data and NVivo for management of the qualitative data. REDCap data dictionaries can be distributed for reuse. The final data dictionaries have not been developed. Scientific data and metadata will be generated, preserved, and shared using NIH common data elements. Scientific data and metadata arising from the project will be uploaded to openICPSR, a self-publishing repository for social, behavioral, and health sciences research data.