Clinical trial NCT03821064: Single-arm Phase II Study of NDURE for Patients With HNC
Official title: Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Keywords: Cancer
Patient Navigation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study will evaluate the feasibility, acceptability, preliminary clinical impact, and preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white and African American (AA) HNC patients and decrease disparities in delay between the two groups by improving system-, interpersonal-, and individual-level health behavior constructs.

Eligibility criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age \> 18 years at the time of screening
2. 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.
3. 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.
4. No prior exposure to radiation therapy, with or without concurrent chemotherapy, for treatment of HNSCC in the definitive or adjuvant therapy settings
5. Plan for curative intent surgery at MUSC
6. 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:

1. Self-identified Hispanic ethnicity
2. Presence of cognitive impairment that precludes participation as determined by oncology provider
3. Prior radiation therapy for HNC
4. Failure to undergo curative intent surgery at MUSC
5. 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

Primary outcomes:
measure: Percent of Patients With a Delay Starting Post-Operative Radiation Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent Difference in PORT Delay Between White and AA HNC Patients.
timeFrame: 6 weeks
measure: Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients
timeFrame: 12 weeks
measure: Time-to-PORT
timeFrame: 12 weeks
measure: Percent of Patients With Pre-Surgical Radiation Consultation
timeFrame: 12 weeks
measure: Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions
timeFrame: 12 weeks
measure: Percent of Patients Surgery to Pathology Reports </= 7 Days
timeFrame: 12 weeks
measure: Percent of Patients With Referral to PORT Within 10 Days of Surgery
timeFrame: 12 weeks
measure: Percent of Patients With RT Consult Within 10 Days of RT Referral
timeFrame: 12 weeks
measure: Percent of Patients With Initiation of RT Within 21 Days of Consultation
timeFrame: 12 weeks
measure: Barriers Resolved
timeFrame: 12 weeks
measure: Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study
timeFrame: 12 weeks
measure: Barriers Unresolved
timeFrame: 12 weeks
measure: Percent of Eligible Participants Who Accrue to NDURE
timeFrame: 13 months
measure: Percentage of Enrolled Participants Who Complete NDURE
timeFrame: 13 months
measure: Navigation Session Completion
timeFrame: 12 weeks
measure: Navigator Caseload
timeFrame: 13 months
measure: Navigator Time Allocation (Direct)
timeFrame: 12 weeks
measure: Navigator Time Allocation (Indirect)
timeFrame: 12 weeks
measure: Satisfaction With the Interpersonal Relationship With the Navigator Scale Score
timeFrame: 12 weeks
measure: Satisfaction With Logistical Aspects of Navigation Scale Score
timeFrame: 12 weeks
measure: Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study
timeFrame: 12 weeks
measure: Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study
timeFrame: 12 weeks
measure: Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study
timeFrame: 12 weeks
measure: Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study
timeFrame: 12 weeks
measure: Change in Perceived Barriers Score From Baseline to End-of-study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Evan Graboyes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P. Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015 Sep;141(9):804-9. doi: 10.1001/jamaoto.2015.1467.
citation: Cramer JD, Speedy SE, Ferris RL, Rademaker AW, Patel UA, Samant S. National evaluation of multidisciplinary quality metrics for head and neck cancer. Cancer. 2017 Nov 15;123(22):4372-4381. doi: 10.1002/cncr.30902. Epub 2017 Jul 20.
citation: Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 1;21(3):555-63. doi: 10.1200/JCO.2003.04.171.
citation: Graboyes EM, Garrett-Mayer E, Ellis MA, Sharma AK, Wahlquist AE, Lentsch EJ, Nussenbaum B, Day TA. Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer. Cancer. 2017 Dec 15;123(24):4841-4850. doi: 10.1002/cncr.30939. Epub 2017 Aug 25.
citation: Graboyes EM, Garrett-Mayer E, Sharma AK, Lentsch EJ, Day TA. Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer. Cancer. 2017 Jul 15;123(14):2651-2660. doi: 10.1002/cncr.30651. Epub 2017 Feb 27.
citation: Divi V, Chen MM, Hara W, Shah D, Narvasa K, Segura Smith A, Kelley J, Rosenthal EL, Porter J. Reducing the Time from Surgery to Adjuvant Radiation Therapy: An Institutional Quality Improvement Project. Otolaryngol Head Neck Surg. 2018 Jul;159(1):158-165. doi: 10.1177/0194599818768254. Epub 2018 Apr 10.