Navigation Intervention for Head and Neck Cancers
(ENDURE Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: Severe mental illness, others
No Placebo Group
Trial Summary
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 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?
* Does ENDURE improve initiation of timely PORT in regards to racial disparities relative to treatment as usual?
* What are the mechanisms through which ENDURE improves timeliness to treatment?
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.
12345Is 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.
13678How 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.
19101112Eligibility 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.
I am 18 years old or older.
+4 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.
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ENDUREExperimental Treatment1 Intervention
ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, equitable 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
Research Locations NearbySelect from list below to view details:
Washington University in St. LouisSaint Louis, MO
Baylor College of MedicineHouston, TX
Duke University Medical CenterDurham, NC
Medical University of South CarolinaCharleston, SC
More Trial Locations
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Cancer Institute (NCI)Collaborator
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]More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy.
Prolongation of definitive head and neck cancer radiotherapy: Survival impact and predisposing factors. [2021]To quantify the survival impact of prolongation of definitive radiotherapy (RT) for head and neck cancer in a national, modern cohort, and to identify predictive factors for prolongation.
A national cancer database analysis on stereotactic body radiation therapy of head and neck cancers. [2021]To evaluate demographic, clinicopathological, treatment factors including biological effective radiation dose (BED) that influence overall survival in head and neck cancer (HNC) patients treated with stereotactic body radiation therapy (SBRT).
Evaluation of deformable image coregistration in adaptive dose painting by numbers for head-and-neck cancer. [2022]To assess the accuracy of contour deformation and feasibility of dose summation applying deformable image coregistration in adaptive dose painting by numbers (DPBN) for head and neck cancer.
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]To determine the impact of body-mass factors (BMF) before radiotherapy and changes during radiotherapy on the magnitude of setup displacement in patients with head and neck cancer (HNC).
Patient-reported quality-of-life outcomes in relation to provider-assessed adverse events during head and neck radiotherapy. [2020]To assess the relationship between patient-reported quality-of-life (QOL) outcomes and provider-assessed adverse events (AEs) during head-and-neck (H&N) radiotherapy (RT).
Socioeconomic Status Drives Racial Disparities in HPV-negative Head and Neck Cancer Outcomes. [2022]To determine drivers of the racial disparity in stage at diagnosis and overall survival (OS) between black and white patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
Early Mortality after Radical Radiotherapy in Head and Neck Cancer - A Nationwide Analysis from the Danish Head and Neck Cancer Group (DAHANCA) Database. [2021]Curative-intent radiotherapy (RT) or chemoradiation (CRT) of squamous cell carcinoma of the head and neck (HNSCC) produces high survival rates, but is associated with substantial toxicity. However, there are no commonly accepted quality metrics for early mortality in radiation oncology. To assess the applicability of early mortality as a clinical quality indicator, this study investigated the temporal distribution, risk factors and trends of 90- and 180-day overall and non-cancer mortality in a nationwide cohort of HNSCC patients treated with RT/CRT.
The effect of navigation programme on the management of symptoms related to head and neck radiotherapy. [2022]This study aims to determine the effect of navigation programme in the management of symptoms related to head and neck cancer (HNC) radiotherapy.
Intrafraction motion quantification and planning target volume margin determination of head-and-neck tumors using cine magnetic resonance imaging. [2019]To quantify intrafractional motion to determine population-based radiotherapy treatment margins for head-and-neck tumors.
Professional patient navigation in head and neck cancer. [2022]To discuss professional cancer navigation roles, models, implementation process and outcomes of patients and families dealing with head and neck cancers. One specific research is presented as an illustration.
Optimization of the interface between radiology, surgery, radiotherapy, and pathology in head and neck tumor surgery: a navigation-assisted multidisciplinary network. [2014]A navigation-assisted multidisciplinary network to improve the interface between radiology, surgery, radiotherapy, and pathology in the field of head and neck cancer is described. All implicated fields are integrated by a common server platform and have remote data access in a ready-to-use format. The margins of resection and exact locations of biopsies are mapped intraoperatively. The pathologist uses the numerical coordinates of these samples to precisely trace each specimen in the anatomical field. Subsequently, map-guided radiotherapy is planned. In addition to the benefits of image-guided resection, this model enables radiotherapy planning according to the specific coordinates of the resection defect plus any residually affected sites identified by the pathologist. Irradiation of adjacent healthy structures is thereby minimized. In summary, the navigation-assisted network described grants timely multidisciplinary feedback between all fields involved, attains meticulous pathological definition, and permits optimized coordinate-directed radiotherapy.