Navigation Intervention for Head and Neck Cancers

(ENDURE Trial)

Recruiting at 5 trial locations

Overseen By Evan M Graboyes, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

532 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called ENDURE (Enhanced Navigation for Disparities and Untimely Radiation Therapy) to help people with head and neck cancer start radiation therapy on time after surgery. The goal is to determine if ENDURE is more effective than the usual treatment process in ensuring patients begin radiation therapy promptly and correctly. Researchers aim to understand how ENDURE functions and what factors aid or impede its use in regular care. The trial seeks participants who have undergone surgery for specific types of head and neck cancer and require further radiation treatment. As an unphased trial, it offers a unique opportunity to contribute to research that could improve timely access to radiation therapy for future patients.

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 prior data suggests that the ENDURE intervention is safe for patients with head and neck cancer?

Research has shown that the ENDURE program helps patients start their radiation therapy on time after surgery for head and neck cancer. Previous tests of this method yielded positive results, enabling patients to begin treatment without unnecessary delays.

Regarding safety, ENDURE is not a drug or medical procedure but a support system that guides patients in following their treatment plans. No reports of harm or side effects have emerged from using this kind of program. It serves as a helpful map to navigate a complex journey.

In short, ENDURE aims to improve treatment timing without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ENDURE because it offers a fresh approach to overcoming barriers in the treatment of head and neck cancers. Unlike standard care, which typically follows established clinical practices, ENDURE is a navigation-based, multilevel intervention designed to help patients adhere more closely to post-operative radiation therapy guidelines. This unique, theoretically-informed strategy aims to ensure timely treatment, potentially improving outcomes by addressing issues that often delay or complicate standard care.

What evidence suggests that the ENDURE intervention is effective for improving timely postoperative radiation therapy in head and neck cancer patients?

Research has shown that the ENDURE program, which participants in this trial may receive, helps head and neck cancer patients start post-surgery radiation therapy on time. Specifically, studies found that patients using ENDURE began their treatments sooner than those receiving regular care. This suggests that ENDURE effectively ensures timely treatment, crucial for optimal cancer care outcomes. The program supports patients in various ways, making it easier for them to adhere to their treatment plans. ^{1 2 6 7 8}

Who Is on the Research Team?

Evan M Graboyes, M.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: ENDURE Experimental Treatment 1 Intervention

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

Group II: Treatment As Usual Active Control 1 Intervention

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

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+

Published Research Related to This Trial

Patients with head and neck cancers who had a professional cancer navigator showed better outcomes, including higher satisfaction and shorter hospital stays, compared to those without a navigator, based on a study of 158 patients (83 with a navigator and 75 without).

The presence of a professional navigator was linked to improved emotional quality of life and fewer cancer-related problems, highlighting the importance of navigation in supporting patients through their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional patient navigation in head and neck cancer. Fillion, L., de Serres, M., Cook, S., et al.[2022]

The navigation-assisted multidisciplinary network enhances collaboration between radiology, surgery, radiotherapy, and pathology in treating head and neck cancer, allowing for precise mapping of resection margins and biopsy locations during surgery.

This integrated approach not only improves the accuracy of surgical procedures but also enables tailored radiotherapy planning that minimizes damage to healthy tissues, optimizing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of the interface between radiology, surgery, radiotherapy, and pathology in head and neck tumor surgery: a navigation-assisted multidisciplinary network. Guijarro-Martínez, R., Gellrich, NC., Witte, J., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 30 head and neck cancer patients, higher body weight and height were linked to increased setup errors during radiotherapy, indicating that these body-mass factors can significantly impact treatment accuracy.

The research suggests that using on-line image-guided radiotherapy can help reduce setup errors, especially for patients with larger body sizes or lower performance status, and highlights the need for adaptive planning based on changes in neck measurements during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of body-mass factors on setup displacement in patients with head and neck cancer treated with radiotherapy using daily on-line image guidance. Lai, YL., Yang, SN., Liang, JA., et al.[2021]

In a study of 65 patients undergoing head-and-neck radiotherapy, those with higher-grade adverse events reported significantly worse quality-of-life outcomes, particularly in areas like fatigue and overall well-being, especially at the beginning of treatment.

As treatment progressed, the negative impact of adverse events on quality of life appeared to decrease, suggesting that patients may adapt over time, and highlighting the importance of considering both patient-reported outcomes and provider-assessed adverse events for a comprehensive understanding of treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported quality-of-life outcomes in relation to provider-assessed adverse events during head and neck radiotherapy. Niska, JR., Thorpe, CS., Halyard, MY., et al.[2020]

In a study of 1,204 patients with HPV-negative head and neck squamous cell carcinoma, black patients were found to have higher odds of being diagnosed at an advanced stage and worse overall survival compared to white patients, even after adjusting for various factors.

However, when socioeconomic status (SES) was considered, the disparity in stage at diagnosis disappeared, suggesting that low SES is a significant factor contributing to these racial disparities and could be a target for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socioeconomic Status Drives Racial Disparities in HPV-negative Head and Neck Cancer Outcomes. Lenze, NR., Farquhar, D., Sheth, S., et al.[2022]

In a study of 11,419 patients with head and neck squamous cell carcinoma treated with curative-intent radiotherapy or chemoradiation, the 90-day and 180-day mortality rates were found to be 3.1% and 7.1%, respectively, indicating a significant risk of early mortality associated with treatment.

The study revealed that factors such as increasing age, cancer stage, and performance status were linked to higher mortality risks, but there was a notable decrease in 180-day mortality rates over time, suggesting improvements in treatment outcomes and questioning the use of early mortality as a standard measure of treatment toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Mortality after Radical Radiotherapy in Head and Neck Cancer - A Nationwide Analysis from the Danish Head and Neck Cancer Group (DAHANCA) Database. Jensen, KH., Vogelius, I., Kristensen, CA., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study involving 100 patients with head-and-neck cancer used cine MR imaging to measure tumor motion during radiotherapy, revealing that the average maximum tumor motion was less than 3.0 mm, but varied significantly among patients (0.1-12.0 mm).

Based on the quantified tumor motion, population-based planning target volume (PTV) margins were established, with specific margins of 2.8 mm for nasopharyngeal tumors, 3.2 mm for oropharyngeal tumors, and 4.3 mm in the inferior-superior direction for laryngeal tumors, ensuring more accurate targeting during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrafraction motion quantification and planning target volume margin determination of head-and-neck tumors using cine magnetic resonance imaging. Bruijnen, T., Stemkens, B., Terhaard, CHJ., et al.[2019]

In a study involving 12 head-and-neck cancer patients, deformable image coregistration was used to adapt treatment plans based on changes in tumor size, showing that visual inspection and adjustment of regions of interest (ROIs) were necessary for accurate dose delivery.

The method demonstrated feasibility for dose summation, indicating that automatic ROI propagation followed by user adjustments is more efficient than manual drawing, although further research is needed to address biological uncertainties in dose summation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of deformable image coregistration in adaptive dose painting by numbers for head-and-neck cancer. Olteanu, LA., Madani, I., De Neve, W., et al.[2022]

A navigation program significantly improved the quality of life for 88 patients undergoing radiotherapy for head and neck cancer, as evidenced by better scores in quality of life assessments throughout treatment.

The program also effectively reduced the severity of common symptoms associated with radiotherapy, such as mucositis, dysphagia, oral pain, and weight loss, indicating its potential as a supportive care intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of navigation programme on the management of symptoms related to head and neck radiotherapy. Duzova, US., Can, G.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national cancer database analysis on stereotactic body radiation therapy of head and neck cancers. Park, JJ., Qureshi, MM., Lam, CM., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39761486/

Randomized Trial of Enhanced Versus Standard ... In this randomized clinical trial of patients with HNSCC undergoing surgery and PORT, NDURE improved initiation of timely PORT, TTP, and TPT.

2. ascopubs.org ascopubs.org/doi/abs/10.1200/OP-24-00901

Randomized Trial of Enhanced Versus Standard ... This trial evaluates the efficacy of Navigation for Disparities and Untimely Radiation thErapy (NDURE), an enhanced navigation-based ...

3. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2023/08/16/hollings-head-and-neck-team-leads-trial-to-reduce-delays-in-care

Hollings head and neck team leads trial to reduce delays in ... Called ENDURE, for Enhanced Navigation for Disparities and Untimely Radiation thErapy, the approach addresses the issue at three levels: ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04030130

Navigation vs Usual Care for Timely Adjuvant Therapy ... Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to ...

5. redjournal.org redjournal.org/article/S0360-3016(24)00296-7/abstract

Efficacy of a Navigation-Based Intervention vs Usual Care ... In this RCT of patients with HNSCC undergoing surgery and PORT, NDURE decreased delays in starting guideline-adherent PORT and improved TTP.

6. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2024-10943

Navigation Intervention for Head and Neck Cancers The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00020

Validating Navigation as Essential Care in Modern Oncology Randomized trial of enhanced versus standard navigation to promote timely initiation of adjuvant radiotherapy for head and neck cancer.

8. medscape.com medscape.com/viewarticle/enhanced-navigation-speeds-time-radiotherapy-hnscc-2025a1000lut

Enhanced Navigation Speeds Up Time to Radiotherapy in ... A randomized trial shows how enhanced navigation leads to more timely postoperative radiotherapy among patients with head and neck cancer.