N/A
N=11
Single-arm Phase II Study of NDURE for Patients With HNC
Cancer of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT03821064 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Percent of Patients With a Delay Starting Post-Operative Radiation Treatment — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Navigation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients With a Delay Starting Post-Operative Radiation Treatment |
4 | — |
| SECONDARY Percent Difference in PORT Delay Between White and AA HNC Patients. |
9.6 | — |
| SECONDARY Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients |
— | — |
| SECONDARY Time-to-PORT |
42 | — |
| SECONDARY Percent of Patients With Pre-Surgical Radiation Consultation |
3 | — |
| SECONDARY Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions |
6 | — |
| SECONDARY Percent of Patients Surgery to Pathology Reports </= 7 Days |
8 | — |
| SECONDARY Percent of Patients With Referral to PORT Within 10 Days of Surgery |
8 | — |
| SECONDARY Percent of Patients With RT Consult Within 10 Days of RT Referral |
6 | — |
| SECONDARY Percent of Patients With Initiation of RT Within 21 Days of Consultation |
3 | — |
| SECONDARY Barriers Resolved |
2.4 | — |
| SECONDARY Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study |
-1.86 | — |
| SECONDARY Barriers Unresolved |
— | — |
| SECONDARY Percent of Eligible Participants Who Accrue to NDURE |
84.6 | — |
| SECONDARY Percentage of Enrolled Participants Who Complete NDURE |
70 | — |
| SECONDARY Navigation Session Completion |
3 | — |
| SECONDARY Navigator Caseload |
3 | — |
| SECONDARY Navigator Time Allocation (Direct) |
100 | — |
| SECONDARY Navigator Time Allocation (Indirect) |
120 | — |
| SECONDARY Satisfaction With the Interpersonal Relationship With the Navigator Scale Score |
39.1 | — |
| SECONDARY Satisfaction With Logistical Aspects of Navigation Scale Score |
43.1 | — |
| SECONDARY Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study |
39.5 | — |
| SECONDARY Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study |
-0.14 | — |
| SECONDARY Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study |
-0.67 | — |
| SECONDARY Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study |
-0.17 | — |
| SECONDARY Change in Perceived Barriers Score From Baseline to End-of-study |
2.2 | — |
Summary
This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer patients.
Eligibility Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age > 18 years at the time of screening
- Histologically or pathologically confirmed invasive squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx (p16 positive, negative, or unknown), hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity.
- 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.
- No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
- Plan for curative intent surgery at MUSC
- Plan for PORT (at MUSC or non-MUSC) with or without concurrent chemotherapy following curative intent surgery
An individual who meets any of the following criteria will be excluded from participation in this study:
- Self-identified Hispanic ethnicity
- Presence of cognitive impairment that precludes participation as determined by oncology provider
- Prior radiation therapy for HNC
- Failure to undergo curative intent surgery at MUSC
- Lack of indication for PORT (with or without concurrent chemotherapy) per National Comprehensive Cancer Network (NCCN) Guidelines based on final pathologic evaluation of adverse features and AJCC pathologic stage grouping
Data sourced from ClinicalTrials.gov (NCT03821064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.