Head and Neck CancerENDURENCT05793151
Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy
A study testing ENDURE in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Medical University of South Carolina at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer
- What is being tested?
- ENDURE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Oct 2023to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Evan Graboyes, M.D., MPH, FACS, (843) 792-0719, graboyes@musc.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Russel R Kahmke, MD, MMCi
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Vlad C Sandulache, MD, PhD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Ryan Jackson, MD, 314 362 8641, jackson.ryan@wustl.edu
About this study
Official 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
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:
- Does ENDURE improve initiation of timely PORT relative to treatment as usual?
- What are the mechanisms through which ENDURE improves timeliness to treatment?
- What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?
Read the detailed 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).
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oral Cavity Cancer, Larynx Cancer
- Being tested
- ENDURE
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Mouth Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDUREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ENDURE | Experimental | ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT. Receives: Behavioral: ENDURE |
| Treatment As Usual | No intervention | Treatment as usual at each site consists of standard of care clinical practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Timely PORT
The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC.
Measured: 3 months
Secondary outcomes (5)
Time-to-PORT
The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.
Measured: 4 months
Pre-Surgical consultation with radiation oncology
Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC.
Measured: 1 month
Pre-radiation therapy dental extractions
The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC.
Measured: 1 month
Time to postoperative scheduling with radiation oncology
The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist.
Measured: 3 months
Time to postoperative appointment with radiation oncology
Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start30 Oct 2023
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomization
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Evan Graboyes, Medical University of South Carolina
- Investigators
- Evan M Graboyes, MD, MPH, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793151
- Sponsor's protocol ID
- Pro00123953
- Other IDs
- R01CA282165
- Acronym
- ENDURE
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05793151
- Acronym / sponsor ID
- ENDURE / Pro00123953
- Conditions
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oral Cavity Cancer, Larynx Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does ENDURE improve initiation of timely PORT relative to treatment as usual?
- What are the mechanisms through which ENDURE improves timeliness to treatment?
- What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?
Detailed 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomization
| Arm | Type | Receives |
|---|---|---|
| ENDURE | Experimental | Behavioral: ENDUREENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT. |
| Treatment As Usual | No intervention | –Treatment as usual at each site consists of standard of care clinical practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDUREENDURE 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. | Behavioural | ENDURE |
Primary outcome
Initiation of Timely PORT
Time frame: 3 months
The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC.
5 secondary outcomes
Time-to-PORT
Time frame: 4 months
Pre-Surgical consultation with radiation oncology
Time frame: 1 month
Pre-radiation therapy dental extractions
Time frame: 1 month
Time to postoperative scheduling with radiation oncology
Time frame: 3 months
Time to postoperative appointment with radiation oncology
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan M Graboyes, MD, MPH principal investigator
Medical University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDURE in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Medical University of South Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan M Graboyes, MD, MPH (843-792-0719, graboyes@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of Timely PORT (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.