Grant Number:	5R01CA282165-03 Interpret this number
Primary Investigator:	Graboyes, Evan
Organization:	Medical University Of South Carolina
Project Title:	A Type I Hybrid Effectiveness-Implementation Trial to Evaluate a Navigation-Based Multilevel Intervention to Decrease Delays Starting Adjuvant Therapy Among Patients with Head and Neck Cancer
Fiscal Year:	2025

This R01 proposal aims to test the effectiveness, mechanism, and implementation of a navigation-based multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy among patients with head and neck cancer (HNC). HNC is a disease with poor survival. For locally advanced HNC, guidelines recommend initiating postoperative radiation therapy (PORT) within 6-weeks of surgery to optimize survival. However, delays starting guideline-adherent PORT (i.e., > 6 weeks after surgery) affect ~50% of patients with HNC and are thus a key driver of poor survival. To date, interventions that improve the delivery of timely, guideline-adherent PORT among patients with HNC are lacking. To address this gap, we developed ENDURE as a navigation-based multilevel intervention that modifies the structure, care delivery pathways, and behaviors of the cancer care multiteam system to address patient-, team-, and organization-level barriers and thus improve the delivery of timely PORT following surgery for HNC. Data from our single-arm and pilot randomized trial provide evidence of NDURE’s feasibility, acceptability, and preliminary effectiveness at improving timely guideline-adherent PORT. To build on these promising data and characterize ENDURE’s implementation across different clinical settings, we propose a hybrid type 1 effectiveness-implementation study. We will conduct a stepped wedge cluster randomized trial with n = 4 cancer centers (N = 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with HNC undergoing surgery and PORT. Concurrently, we will conduct a mixed-methods study with quantitative assessments supplemented by semi-structured interviews of patients, providers, and administrators to characterize the implementation of ENDURE. Specific Aim 1 will evaluate the effectiveness of ENDURE on starting timely, guideline-adherent PORT relative to TAU. Specific Aim 2 will identify the mechanisms through which ENDURE improves the delivery of timely PORT. Specific Aim 3 will characterize the implementation of ENDURE across different clinical settings. Findings from our proposal have potential to address three important gaps. First, effectiveness results may provide support for ENDURE as the first evidence-based strategy to improve the initiation of timely adjuvant therapy for patients with HNC. Such a result may help change the current standard of care and improve survival for these patients. Second, findings address an understudied but critical aspect of cancer care delivery and could be translated to other types of cancer (e.g., breast, colon, lung) for which delays initiating adjuvant therapy are common. Third, mechanism data may provide actionable knowledge to improve the delivery of effective interprofessional team-based cancer care.




Barriers and Timely Postoperative Radiation Therapy in Head and Neck Cancer.
Authors: Nguyen M.T. , Kistner-Griffin E. , DeMass R. , Chera B.S. , Halbert C.H. , Sterba K.R. , Hill E.G. , Nussenbaum B. , Alberg A.J. , Sandulache V.C. , et al. .
Source: Jama Otolaryngology-- Head & Neck Surgery, 2025-09-11 00:00:00.0; , .
EPub date: 2025-09-11 00:00:00.0.
PMID: 40932734
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Disparities in Survival of Head and Neck Cancer in the Hispanic Population: Systematic-Review and Meta-analysis.
Authors: Marrero-Gonzalez A.R. , Nanu D.P. , Nguyen S.A. , Brennan E.A. , Albergotti W.G. , Chera B.S. , Harper J.L. , Kaczmar J.M. , Kejner A.E. , Newman J.G. , et al. .
Source: Otolaryngology--head And Neck Surgery : Official Journal Of American Academy Of Otolaryngology-head And Neck Surgery, 2025 Apr; 172(4), p. 1177-1191.
EPub date: 2025-01-05 00:00:00.0.
PMID: 39756015
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Randomized Trial of Enhanced Versus Standard Navigation to Promote Timely Initiation of Adjuvant Radiotherapy for Head and Neck Cancer.
Authors: Graboyes E.M. , DeMass R. , Sterba K.R. , Chera B.S. , Kistner-Griffin E. , Hill E.G. , McCay J. , Newman J.G. , Albergotti W.G. , Kejner A.E. , et al. .
Source: Jco Oncology Practice, 2025-01-06 00:00:00.0; , p. OP2400901.
EPub date: 2025-01-06 00:00:00.0.
PMID: 39761486
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Factors Associated with Head and Neck Cancer Postoperative Radiotherapy Delays: A Systematic Review and Meta-analysis.
Authors: Duckett K.A. , Kassir M.F. , Nguyen S.A. , Brennan E.A. , Chera B.S. , Sterba K.R. , Halbert C.H. , Hill E.G. , McCay J. , Puram S.V. , et al. .
Source: Otolaryngology--head And Neck Surgery : Official Journal Of American Academy Of Otolaryngology-head And Neck Surgery, 2024 Nov; 171(5), p. 1265-1282.
EPub date: 2024-06-06 00:00:00.0.
PMID: 38842034
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Disparities in Care for Patients with Head and Neck Cancer.
Authors: Marrero-Gonzalez A.R. , Graboyes E.M. .
Source: Surgical Oncology Clinics Of North America, 2024 Oct; 33(4), p. 669-681.
EPub date: 2024-06-04 00:00:00.0.
PMID: 39244286
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Neighborhood-Level Disadvantage and Delayed Adjuvant Therapy in Head and Neck Cancer.
Authors: Graboyes E.M. , Cagle J.L. , Ramadan S. , Prasad K. , Yan F. , Pearce J. , Mazul A.L. , Anoma J.S. , Hill E.G. , Chera B.S. , et al. .
Source: Jama Otolaryngology-- Head & Neck Surgery, 2024-04-25 00:00:00.0; , .
EPub date: 2024-04-25 00:00:00.0.
PMID: 38662392
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Author Reply to Letter by Topkan et al Regarding Delays in Starting Postoperative Radiotherapy.
Authors: Duckett K.A. , Lee B.J. , Chera B.S. , Puram S.V. , Sandulache V.C. , Kahmke R. , Nguyen S.A. , Nussenbaum B. , Alberg A.J. , Halbert C.H. , et al. .
Source: Otolaryngology--head And Neck Surgery : Official Journal Of American Academy Of Otolaryngology-head And Neck Surgery, 2024-04-24 00:00:00.0; , .
EPub date: 2024-04-24 00:00:00.0.
PMID: 38655738
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Delays Starting Postoperative Radiotherapy Among Head and Neck Cancer Patients: A Systematic Review and Meta-analysis.
Authors: Duckett K.A. , Kassir M.F. , Nguyen S.A. , Brennan E.A. , Chera B.S. , Sterba K.R. , Hughes Halbert C. , Hill E.G. , McCay J. , Puram S.V. , et al. .
Source: Otolaryngology--head And Neck Surgery : Official Journal Of American Academy Of Otolaryngology-head And Neck Surgery, 2024 Feb; 170(2), p. 320-334.
EPub date: 2023-09-20 00:00:00.0.
PMID: 37731255
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Patient Navigation for Timely, Guideline-Adherent Adjuvant Therapy for Head and Neck Cancer: A National Landscape Analysis.
Authors: Graboyes E.M. , Chappell M. , Duckett K.A. , Sterba K. , Hughes Halbert C. , Hill E.G. , Chera B. , McCay J. , Puram S.V. , Ramadan S. , et al. .
Source: Journal Of The National Comprehensive Cancer Network : Jnccn, 2023 Dec; 21(12), p. 1251-1259.e5.
PMID: 38081134
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Allyship to Advance Diversity, Equity, and Inclusion in Otolaryngology: What We Can All Do.
Authors: Balakrishnan K. , Faucett E.A. , Villwock J. , Boss E.F. , Esianor B.I. , Jefferson G.D. , Graboyes E.M. , Thompson D.M. , Flanary V.A. , Brenner M.J. .
Source: Current Otorhinolaryngology Reports, 2023 Sep; 11(3), p. 201-214.
EPub date: 2023-07-04 00:00:00.0.
PMID: 38073717
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Treatment Delays in Oral Cavity Cancer-Time, Time, Time, See What's Become of Me.
Authors: Graboyes E.M. , Yom S.S. .
Source: Jama Otolaryngology-- Head & Neck Surgery, 2023-07-09 00:00:00.0; , .
EPub date: 2023-07-09 00:00:00.0.
PMID: 37422843
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