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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
Must not have
Synchronous untreated malignancy expected to impact life expectancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another cancer that has not been treated and could shorten my life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Initiation of Timely PORT
Secondary study objectives
Pre-Surgical consultation with radiation oncology
Pre-radiation therapy dental extractions
Time to postoperative appointment with radiation oncology
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
979 Previous Clinical Trials
7,400,462 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,048 Total Patients Enrolled
Evan M Graboyes, MD, MPHPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
54 Total Patients Enrolled