CovidSurg-Cancer HEAD & NECK Follow-Up Study - Long term outcomes of elective cancer surgery for malignancies of the Head & Neck during the COVID-19 pandemic crisis.

The primary intention of the COVIDSurg-Cancer study was to evaluate the 30-day SARS-CoV-2 infection rates in elective cancer surgery. The end points for that project were restricted to evaluation at a timepoint only four months following the first enrolled case (June 2020) however significant clinically relevant questions that cannot be addressed within the intended study window remain, particularly for Head & Neck Cancer patients.

Of paramount importance for this patient group, is assessment of whether the changes in care, deemed necessary at the time, have had a long-term impact on patient outcomes.

To that end, we will extend follow up analysis for Head & Neck cancer patients through inclusion of mature (12 & 24 month) outcome data and of additional data fields of specific head & neck importance, including aspects such as the influence of modified surgical practices on functional outcomes and disease-free intervals. These data points and assessment timepoints were beyond the remit of the original CovidSurg-Cancer study.

This follow-up study seeks to address the hypothesis that the COVID-19 pandemic, and unintended consequences of alteration in clinical management, have negatively impacted upon outcomes (survival or otherwise).

To evaluate the impact of treatment delay and/or case management alteration of patients treated during the COVID-19 pandemic (March-June 2020) in terms of survival and function.

COVIDSurg-Cancer HEAD & NECK Follow-Up Study is an international, multi-centre, audit of current practice.

All sites who enrolled patients with a diagnosis of Head & Neck malignancy into the COVIDSurg-Cancer study are invited to continue to follow-up their patients. 

Sites will not be required to identify any new patients. Patients enrolled during the 3-month study period of the COVIDSurg-Cancer (early 2020) will be followed up at the 12 and 24 months time points.  

There is no change to the patient treatment, the CovidSurg-Cancer HEAD &NECK Follow-Up Study is an audit of practice.

All patients who were included in COVIDSurg-Cancer with diagnosis of Head & Neck malignancy are eligible for long-term follow-up at 12 and 24 months post study entry date (June 2021 & June 2022).

Table of key dates and milestones in the CovidSurg Cancer Head and Neck Follow-up Study

Milestones	Key Dates
Bolt-On Head & Neck Follow-Up Study Protocol released	19-April-2021
Sites can start to confirm their intention to continue to follow-up their patients	19-April-2021
12 month follow up data collection	01 - 30-June-2021
24 month follow up data collection	01 - 30-June-2022

• Prospective data collection at 12 and 24 time points (data collection during June 2021 and June 2022)
• Only routinely collected data will be used
• No patient identifiable information will be uploaded to the central study database
• Data will not be published at identifiable hospital level

For all collaborators from sites, the corporate authorship model will be followed, as was the case in the parent COVIDSurg and COVIDSurg Cancer Studies (see publication).  Those collaborators who contribute follow-up data on at least one patient will be recognised on any resulting publications as PubMed-citable co-authors. Flexible to service demands and given the longer-term nature of data capture, no authorship limits will be imposed at a centre level; as many collaborating investigators are required, and work to support the project will be recognised on all future outputs.

• Prospective data collection at 12 and 24 time points (data collection during June 2021 and June 2022)
• Data will be collected using the secure web application REDCap
• Complete one CRF per patient at each time point

If your hospital captured patient information for COVIDSurg-Cancer during the 3-month identification window (typically March-May 2020):

1. Confirm your continued intention to follow-up these patients longer term here: https://redcap.link/covidsurgfu.  The information you provide in the survey will help us keep in touch with you during the study and to create logins for you to access the study database.
2. Please ensure that you maintain your local records linking Medical Record Numbers with REDCap IDs (the COVIDSurg Link Sheet)
3. Review the local approval (ethical, audit or institutional review board) that was required for the initial COVIDSurg-Cancer study and resubmit as necessary for the CovidSurg-Cancer HEAD & NECK Follow-Up Study to ensure that approval remains in place for the extended follow-up.