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Navigation Intervention for Head and Neck Cancers (ENDURE Trial)

N/A

Recruiting

Led By Evan M Graboyes, MD, MPH

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Squamous cell carcinoma (SCC) (or histologic variant) of specified anatomical locations

Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on specified adverse features on final pathologic evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

ENDURE Trial Summary

This trial will compare an intervention to usual care to see if it reduces delays in radiation therapy for head and neck cancer & reduce racial disparities.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on a navigation-based intervention rather than a drug, there are no direct side effects like those associated with medication. However, participants may experience general stress or inconvenience related to participation in clinical research.

ENDURE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have squamous cell carcinoma in a specific part of my body.

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I am scheduled for post-surgery radiation, possibly with chemotherapy, due to certain findings.

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I am 18 years old or older.

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My cancer is at an advanced stage according to AJCC guidelines.

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I plan to have my surgery at a clinic involved in the study.

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I have never had radiation therapy for head and neck cancer.

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I am scheduled for surgery aimed at curing my condition at a participating center.

ENDURE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PORT Delay

Secondary outcome measures

Pre-Surgical consultation with radiation oncology

Pre-radiation therapy dental extractions

Time to postoperative appointment with radiation oncology

+2 more

ENDURE Trial Design

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,104 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,925,909 Total Patients Enrolled

Evan M Graboyes, MD, MPHPrincipal InvestigatorMedical University of South Carolina

1 Previous Clinical Trials

54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this investigative trial for qualified participants?

"Confirmed. Clinicaltrials.gov indicates that this research project is currently recruiting patients, and it was initially posted on October 30th 2023 with the latest edit occurring on the same date."

Answered by AI

To what extent has participation been reached in this clinical experiment?

"This study necessitates the enrollment of 532 eligible individuals. Patients from Duke University Medical Center in Durham, North carolina and Medical University of South carolina in Charleston, South Carolina are amongst those that can be included."

Answered by AI

At how many venues is this clinical research currently being conducted?

"Currently, 4 medical centres are open to accepting participants in this study. These locations include Durham, Charleston and Houston as well as other nearby sites; thus minimizing the amount of travel necessary for potential enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy

Evan Graboyes 2023. "Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05793151.