Ambulatory follow-up care and monitoring of cancer patients during SARS-CoV-2 pandemic by collecting blood samples at home and monitoring systemic therapy using a smartphone application (COREO-trial)

Background: There is a broad range of clinical presentations of a SARS-CoV-2 viral infection varying from asymptomatic, sensation of a mild cold or flu to severe bilateral pneumonia and death. Liang et al. already reported the most severe complications in cancer patients particularly when they had undergone chemotherapy or surgery over the last month. In absence of a vaccine or adequate treatment of COVID-19 current measures to minimize the infectious risk of SARS-CoV-2 in a cancer patient population are focused on social distancing and protective measures for the medical and nursing staff members, and in some settings also patients. As it is clear that a hospital is a high risk setting to contract COVID-19, one of the strategies we can use to treat cancer patients as safe as possible, is to reduce hospital visits to a strict minimum. Trial design: The COREO-trial is a non-randomized cohort study at the Oncology unit of the Antwerp University Hospital (COVID-19 reference center) and AZ Maria Middelares Gent, both in Belgium. This trial contains two groups. Group A consists of patients that undergo outpatient monitoring (blood sampling at home and monitoring side effects using a smartphone application). Group B consists of patients that are in the classical hospital setting (= control group). The primary objective is to assess whether patients having home monitored oncologic treatment (cohort A) have a lower risk to the develop (severe) clinical COVID-19 compared to patients having classic in hospital oncologic treatment (cohort B). The working hypothesis is that interactive outpatient monitoring and management within the COREO-trial allows high quality cancer care with reduction of COVID-19 related complications. Legal entity responsible for the study: Antwerp University Hospital. Funding: Antwerp University Hospital. Disclosure: All authors have declared no conflicts of interest.