Patient Navigation for Head and Neck Cancer
(NDURE2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?Head and neck cancer squamous cell carcinoma (HNSCC) is a disease with poor survival, especially for African Americans, despite intense treatment including surgery, radiation, and chemotherapy. Delays between surgery and the start of postoperative radiation therapy (PORT) are common, cause excess mortality, and contribute to worse survival in African Americans. Our research team has developed NDURE (Navigation for Disparities and Untimely Radiation thErapy), a novel theory-based patient navigation (PN) intervention to decrease delays and racial disparities starting PORT. In this single-site, open label, parallel-group, randomized controlled trial of adults with surgically-managed, locally advanced HNSCC, will be randomized to NDURE versus usual care to assess the preliminary clinical impact of NDURE on delays and racial disparities starting PORT after surgery for HNSCC. The investigators will collect information about the rate of PORT delay, racial disparities in the rate of PORT delay, and completion rate of key cancer care processes. Participants will also complete validated questionnaires at baseline and post-intervention to understand the theoretical constructs underlying NDURE . Post-intervention, patients and providers will undergo interviews to obtain in-depth understanding of the content, format, timing, and delivery of NDURE to optimize the intervention in preparation for a future multi-site study. NDURE could provide the first effective intervention to improve the delivery of timely, equitable PORT after HNC surgery, thereby improving survival for patients with HNC, decreasing racial disparities in mortality, and developing new standards of clinical care.

Eligibility Criteria

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.

Inclusion Criteria

My surgeon believes surgery could cure my head and neck cancer.

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.

+8 more

Exclusion Criteria

I have another cancer that hasn't been treated yet.

I did not have surgery aimed at curing my condition.

I do not have any cognitive issues that prevent me from participating.

+2 more

Participant Groups

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.

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.