532 Participants Needed

Navigation Intervention for Head and Neck Cancers

(ENDURE Trial)

Recruiting at 4 trial locations
EM
Evan M Graboyes, M.D. profile photo
Overseen ByEvan M Graboyes, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ENDURE for head and neck cancers?

The study on NDURE, a similar navigation-based intervention, shows that it is feasible and acceptable, with preliminary evidence suggesting it may help patients start their radiation therapy on time, which is crucial for improving survival rates in head and neck cancer.12345

Is the Navigation Intervention for Head and Neck Cancers safe for humans?

The study on NDURE (Navigation for Disparities and Untimely Radiation thErapy) evaluated its feasibility and acceptability, which suggests it was considered safe enough to test, but specific safety data is not detailed in the available research.13678

How is the ENDURE treatment different from other treatments for head and neck cancers?

ENDURE is unique because it uses a navigation-based approach to ensure patients receive timely and guideline-adherent radiation therapy after surgery, which helps reduce delays and improve survival rates. This approach is particularly focused on addressing disparities in treatment access and outcomes.19101112

What is the purpose of this trial?

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?

Research Team

Evan Michael Graboyes, MD, MPH, FACS in ...

Evan M Graboyes, M.D.

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults over 18 with certain types of head and neck cancers, including oral and laryngeal cancers, who plan to have surgery but haven't had radiation therapy for these cancers before. They should be able to speak and write English and not have severe mental illness or another untreated cancer that affects life expectancy.

Inclusion Criteria

I have squamous cell carcinoma in a specific part of my body.
I am scheduled for post-surgery radiation, possibly with chemotherapy, due to certain findings.
My cancer is at an advanced stage according to AJCC guidelines.
See 3 more

Exclusion Criteria

Inability to speak or write English
I have another cancer that has not been treated and could shorten my life.
You have a serious mental illness that would make it difficult for you to take part in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Consultation

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

1 month

Pre-Radiation Therapy Dental Extractions

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

1 month

Treatment

Initiation of postoperative radiation therapy (PORT) following definitive surgery for HNSCC

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

  • ENDURE
Trial Overview The ENDURE intervention is being tested against the usual treatment process to see if it can reduce delays in starting postoperative radiation therapy (PORT) after surgery for head and neck cancer patients. The study also examines if ENDURE helps minimize racial disparities in treatment delays.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ENDUREExperimental Treatment1 Intervention
ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT.
Group II: Treatment As UsualActive Control1 Intervention
Treatment as usual at each site consists of standard of care clinical practices

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The NDURE intervention, designed to improve timely postoperative radiation therapy (PORT) for head and neck squamous cell carcinoma (HNSCC), was found to be feasible and acceptable, with 100% of enrolled Black patients reporting positive experiences.
The implementation of NDURE resulted in an impressive 86% rate of timely, guideline-adherent PORT overall, and 100% for Black patients, highlighting its potential to address disparities in cancer treatment.
Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer.Graboyes, EM., Sterba, KR., Li, H., et al.[2022]
Prolonging definitive radiotherapy (RT) for head and neck cancer increases the risk of death, with a 2% increase in the hazard of death for each additional day of treatment delay, and significant survival reductions observed for delays of 4-8 days (4% lower survival) and more than 8 days (12% lower survival).
Key factors contributing to RT prolongation include the use of systemic therapy, higher baseline comorbidity, lack of private insurance, and tumor stage, while treatment at high-volume facilities (more than 11.5 patients/year) significantly reduces the risk of prolonged treatment.
Prolongation of definitive head and neck cancer radiotherapy: Survival impact and predisposing factors.Xiang, M., Gensheimer, MF., Pollom, EL., et al.[2021]
In a study of 591 head and neck cancer patients treated with stereotactic body radiation therapy (SBRT), factors such as older age, higher comorbidity scores, and advanced cancer stages were linked to poorer overall survival rates, which had a 5-year survival rate of only 15.5%.
Patients receiving SBRT combined with chemotherapy or surgery showed better survival outcomes compared to those receiving SBRT alone, particularly when the biological effective radiation dose (BED10) was 59.5 Gy or higher, indicating that higher doses may improve treatment efficacy.
A national cancer database analysis on stereotactic body radiation therapy of head and neck cancers.Park, JJ., Qureshi, MM., Lam, CM., et al.[2021]

References

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer. [2022]
Prolongation of definitive head and neck cancer radiotherapy: Survival impact and predisposing factors. [2021]
A national cancer database analysis on stereotactic body radiation therapy of head and neck cancers. [2021]
Evaluation of deformable image coregistration in adaptive dose painting by numbers for head-and-neck cancer. [2022]
Impact of body-mass factors on setup displacement in patients with head and neck cancer treated with radiotherapy using daily on-line image guidance. [2021]
Patient-reported quality-of-life outcomes in relation to provider-assessed adverse events during head and neck radiotherapy. [2020]
Socioeconomic Status Drives Racial Disparities in HPV-negative Head and Neck Cancer Outcomes. [2022]
Early Mortality after Radical Radiotherapy in Head and Neck Cancer - A Nationwide Analysis from the Danish Head and Neck Cancer Group (DAHANCA) Database. [2021]
The effect of navigation programme on the management of symptoms related to head and neck radiotherapy. [2022]
Intrafraction motion quantification and planning target volume margin determination of head-and-neck tumors using cine magnetic resonance imaging. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Professional patient navigation in head and neck cancer. [2022]
Optimization of the interface between radiology, surgery, radiotherapy, and pathology in head and neck tumor surgery: a navigation-assisted multidisciplinary network. [2014]
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