Comparing navigation support to standard care for starting radiation therapy in head and neck cancer patients
A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer
This study is testing a new support program to help people with head and neck cancer start their radiation therapy on time compared to the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 532 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (St Louis, Missouri and 3 other locations) |
| Trial ID | NCT05793151 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a navigation-based intervention called ENDURE compared to standard treatment in facilitating timely initiation of postoperative radiation therapy (PORT) for patients with head and neck cancer. The study will involve four cancer centers and approximately 484 patients, utilizing a stepped-wedge cluster randomized design to assess the impact of ENDURE on treatment initiation and address racial disparities. Additionally, the trial will explore the mechanisms by which ENDURE may improve treatment timeliness through mixed-methods research, including both quantitative and qualitative data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with squamous cell carcinoma of the head and neck who are planning to undergo curative intent surgery followed by postoperative radiation therapy.
Not a fit: Patients who have previously received radiation therapy for head and neck cancer or those not planning for curative intent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the timely initiation of radiation therapy for head and neck cancer patients, potentially improving their treatment outcomes.
How similar studies have performed: Other studies have shown promise in improving treatment initiation through navigation interventions, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>/= 18 years 2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity 3. American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or \>N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary. 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT. 5. Plan for curative intent surgery at one of the participating centers 6. Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI). Exclusion Criteria: 1. Inability to speak or read English or Spanish. 2. Severe mental illness that would prevent trial participation. 3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \< 3 cm 4. Synchronous untreated malignancy expected to impact life expectancy
Where this trial is running
St Louis, Missouri and 3 other locations
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Evan M Graboyes, MD, MPH — Medical University of South Carolina
- Study coordinator: Evan M Graboyes, MD, MPH
- Email: graboyes@musc.edu
- Phone: 843-792-0719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.