ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.
Subject(s)
COVID-19 , Neoplasms , Humans , Pandemics , SARS-CoV-2 , Medical Oncology , Neoplasms/therapyABSTRACT
The impact of the coronavirus disease 2019 (COVID-19) pandemic on the management of head and neck cancer must be addressed. Immediate measures to reduce transmission rates and protect patients and providers take priority and necessitate some delays in care, particularly for patients with mild symptoms or less aggressive cancers. However, strict guidelines have yet to be developed, and many unintentional delays in care are to be expected based on the magnitude of the looming public health crisis. The medical complexity of head and neck cancer management may lead to prolonged delays that worsen treatment outcomes. Therefore, those caring for patients with head and neck cancer must take action to reduce these negative impacts as the country rallies to overcome the challenges posed by this pandemic.
Subject(s)
Communicable Disease Control/organization & administration , Coronavirus Infections/prevention & control , Disease Transmission, Infectious/prevention & control , Head and Neck Neoplasms/therapy , Pandemics/prevention & control , Patient Safety , Pneumonia, Viral/prevention & control , COVID-19 , Disease Management , Disease Outbreaks/statistics & numerical data , Female , Head and Neck Neoplasms/epidemiology , Head and Neck Neoplasms/immunology , Humans , Immunocompromised Host , Male , Outcome Assessment, Health Care , Pandemics/statistics & numerical data , Risk Assessment , United States , Vulnerable Populations/statistics & numerical dataABSTRACT
BACKGROUND AND METHODS: There is an added level of complexity in the management of head and neck cancer patients with underlying immunosuppressive disorders during the COVID-19 pandemic. Head and neck oncologists are tasked with balancing the dual risks of cancer progression in the setting of impaired tumor immunity and increased susceptibility to life-threatening complications from exposure to viral infection for patients and providers. Through two cases of immunocompromised patients with newly diagnosed head and neck malignancies, we aim to provide guidance to clinicians struggling with how to best counsel and manage this unique subset of patients under these difficult circumstances. RESULTS: After careful consideration of the options, we took different approaches in the care of these two patients. CONCLUSIONS: Ultimately, there is no uniform set of rules to apply to this heterogeneous group of immunocompromised patients. We provide some general principles to help guide patient management during the current pandemic.