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Patient Navigation for Head and Neck Cancer (NDURE2 Trial)
N/A
Waitlist Available
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
American Joint Committee on Cancer (AJCC) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity; or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary
Histologically or pathologically confirmed invasive SCC (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
NDURE2 Trial Summary
This trial is testing a new patient navigation intervention to decrease delays and racial disparities in postoperative radiation therapy (PORT) after surgery for head and neck cancer squamous cell carcinoma (HNSCC).
Who is the study for?
Adults over 18 with advanced head and neck squamous cell carcinoma (HNSCC) who are planning curative surgery at MUSC. They must not have had prior radiation for HNSCC, should likely need post-surgery radiation therapy, and can't be of Hispanic ethnicity or have cognitive impairments that prevent participation.Check my eligibility
What is being tested?
The trial is testing NDURE, a patient navigation intervention designed to reduce delays in starting postoperative radiation therapy (PORT) after HNSCC surgery. It aims to improve survival rates and decrease racial disparities by ensuring timely PORT.See study design
What are the potential side effects?
Since NDURE is a patient navigation intervention rather than a drug, it does not have physical side effects. However, participants may experience changes related to the process of care.
NDURE2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in an advanced stage according to specific cancer staging guidelines.
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My cancer is confirmed in specific areas of the head or neck.
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I am scheduled for surgery aimed at curing my condition at MUSC.
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I have not had radiation or chemo for head and neck cancer before.
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I am older than 18 years.
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I am scheduled for post-surgery radiation therapy, with or without chemotherapy.
NDURE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delay Initiating Postoperative Radiation Therapy (PORT)
Time interval between surgery and the start of PORT
Secondary outcome measures
Barriers Resolution Rate
Care Transition Measure-15 (CTM-15) Score
Change from Baseline in Communication & Attitudinal Self-Efficacy Scale (CASE)-Cancer Score
+11 moreNDURE2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NDUREExperimental Treatment1 Intervention
NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system-(care coordination), interpersonal-(social support), and individual- (health belief model [HBM]; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, enhance HNSCC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE navigation sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit, time points chosen to facilitate case identification and coordination across key care transitions.
Group II: Usual CareActive Control1 Intervention
UC consists of discussions about the indications, risks/benefits/alternative, Guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NDURE
2019
N/A
~20
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,438 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,466 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon believes surgery could cure my head and neck cancer.I have another cancer that hasn't been treated yet.My cancer is in an advanced stage according to specific cancer staging guidelines.My cancer is confirmed in specific areas of the head or neck.I did not have surgery aimed at curing my condition.I do not have any cognitive issues that prevent me from participating.I am diagnosed with severe skin cell changes or SCC in-situ and scheduled for surgery.My surgery for head and neck cancer is expected to be followed by additional treatment due to high-risk features.My biopsy showed early-stage skin cancer or severe skin changes but no invasive cancer.I am scheduled for surgery aimed at curing my condition at MUSC.I have not had radiation or chemo for head and neck cancer before.My cancer stage was confirmed with specific scans within the last 30 days.My cancer does not require post-surgery radiation according to NCCN guidelines due to certain risk factors.I am older than 18 years.I am scheduled for post-surgery radiation therapy, with or without chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: NDURE
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently open?
"Per the information provided on clinicaltrials.gov, this medical trial is presently seeking participants. It was initially posted in May 19th 2020 and most recently updated on 25th of May 2022."
Answered by AI
What is the participant count for this clinical trial?
"That is accurate. According to clinicaltrials.gov, this non-randomized trial which was first published on May 19th 2020 remains actively recruiting participants. 190 individuals need to be enrolled from a single location for the study to succeed."
Answered by AI
What is the intended outcome of this exploration?
"This clinical trial aims to postpone the initiation of Postoperative Radiation Therapy (PORT) for 12 weeks from surgery. Additionally, it will measure Change from Baseline in Perceived Barriers Scale - a self-report survey used to evaluate potential roadblocks facing cancer care; Change from Baseline in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score (HNSCC Modification), which is scored on a 5 point Likert scale and provides an assessment of disease severity; as well as Unresolved Barriers that have not been solved by navigators during NDURE intervention."
Answered by AI
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