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Navigation vs Usual Care for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC
NA trial testing NDURE in Squamous Cell Carcinoma of Head and Neck in 176 participants. Completed in 29 January 2024.
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 176 |
| Start date | 19 May 2020 |
| Primary completion | 11 December 2023 |
| Estimated completion | 29 January 2024 |
| Sites | 1 location across United States |
Medical University of South Carolina
18 and older, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
defined per National Comprehensive Cancer Network Guidelines as the initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 14 | |
| Usual Care | 46 |
Time, in days, between the date of definitive surgical resection to the initiation of radiation therapy
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 39 | 36 – 40 |
| Usual Care | 47 | 43 – 50 |
number of days from the date of definitive surgery for HNSCC to the date of PORT completion.
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 84 | 81 – 85 |
| Usual Care | 89 | 87 – 94 |
defined per National Comprehensive Cancer Network Guidelines as the initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC between evaluable white and black patients with HNSCC
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 3 | |
| Usual Care | 14 |
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 11 | |
| Usual Care | 32 |
Difference between White and Black patients with HNSCC in the number of days between the date of definitive surgical resection to the initiation of radiation therapy.
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 38 | 36 – 46 |
| Usual Care | 55 | 43 – 60 |
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 39 | 35 – 40 |
| Usual Care | 45 | 42 – 49 |
Difference between White and Black patients with HNSCC in the number of days from the date of definitive surgery for HNSCC to the date of PORT completion.
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 83 | 78 – 89 |
| Usual Care | 93 | 85 – 105 |
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 84 | 81 – 85 |
| Usual Care | 88 | 85 – 93 |
The measures assesses the performance (or lack thereof) of a care delivery process (Pre-Surigcal Radiation Consultation) for patients with HNSCC. The measure is evaluated as performed if the patient attends a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 47 | |
| Usual Care | 31 |
The measures assesses the performance (or lack thereof) of a care delivery process (Pre-Radiation Therapy Dental Extractions) for patients with HNSCC. The measure is evaluated as performed if the patient has extraction of his/her indicated teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure.
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 44 | |
| Usual Care | 31 |
The measures assesses the time, in days, from the date of the definitive surgical procedure to the date the referral (or postoperative appointment) is placed to discuss adjuvant therapy with the treating radiation oncologist
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 8 | 8 – 9 |
| Usual Care | 16 | 14 – 17 |
the time, in days, from the date of the definitive surgical procedure to the date that the patient attends a postoperative appointment with radiation oncology
| Group | Value | 95% CI |
|---|---|---|
| NDURE | 20.0 | 19 – 21 |
| Usual Care | 24.5 | 23 – 29 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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