Single-arm Phase II Study of NDURE for Patients With HNC

NCT ID: NCT03821064

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2019-11-21

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.

Conditions

Cancer of Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Navigation

45 patients (15 African American, 30 white) will interact with a patient navigator three times over three months to identify and address barriers before they cause breakdowns in care delivery, employing resources, education, and care coordination from the day of surgery until post-operative radiation treatment begins.

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: OTHER

NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC 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 sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.

Interventions

Patient Navigation

NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC 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 sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Evan Graboyes

Assistant Professor, Department of Otolaryngology- Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan Graboyes, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26313895 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28727137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12560449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28841234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28241092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29631478 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00077402

Identifier Type: -

Identifier Source: org_study_id