None listed
Conditions
Brief summary
This study will assess the feasibility and uptake of self-directed testing for COVID-19 and other seasonal respiratory viruses among patients undergoing treatment for their cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been clinically and pathologically diagnosed with any cancerous malignancy, you are receiving active treatment for your cancer at one of the participating Icon Cancer Centres (VIC, NSW, QLD only) and you are able to self-collect and return samples to a Sonic HealthCare laboratory. Study details Participants who enrol in this study will be instructed to collect four test kits containing the specimen swab, tongue depressor, test tube for completed sample, educational pamphlet, a pathology request form and a list of dedicated COVID-19 testing centres. Participants will also be given a link to the Sonic HealthCare web page containing a “how to self-collect” tutorial video in order to ensure specimens are collected correctly and as a measure of ensuring maximum standardization among participants. Participants who are unable to access the web link will be referred to Sonic HealthCare for telephone training which is anticipated to take approximately 5 minutes. Participants will be asked to self-collect throat and nose sample specimens at home (throat and nose specimens will be collected with one swab). The frequency of testing is once weekly for a period of four weeks totally four test per participant. Participants will also be asked to keep a symptom score and temperature electronic diary which they will complete each day until the end of study (4 weeks). This will be done by emailing each participant an easy to use survey each day to track their symptoms. It is hoped this research will determine whether self-administered testing for COVID-19 and other respiratory illness by participants in their own home is feasible and effective. If this method of sample collection is effective, this method of testing may be used in the future, which could assist vulnerable patients including those with cancer.
Interventions
Patient’s receiving active treatment for their cancer at participating Icon Cancer centre sites will be emailed a letter of invitation to take part in this self-testing study. The tests performed in this study do not cancel out the need to seek further testing (performed by a healthcare professional) if patients believe they may have been in contact with a confirmed COVID-19 case or are displaying symptoms of COVID-19. Likewise, patients are encouraged to follow state and federal guidelines if t
Patient’s receiving active treatment for their cancer at participating Icon Cancer centre sites will be emailed a letter of invitation to take part in this self-testing study. The tests performed in this study do not cancel out the need to seek further testing (performed by a healthcare professional) if patients believe they may have been in contact with a confirmed COVID-19 case or are displaying symptoms of COVID-19. Likewise, patients are encouraged to follow state and federal guidelines if they have visited a COVID-19 “hotspot”. Only patient's taking part in this study will be asked to self-collect throat and nose samples for COVID-19 detection. Study participants will collect their test kits from Icon reception staff at their next visit. Participants will receive a one-page “how to self-collect for COVID-19” pamphlet in their testing kits, this has been developed by Sonic Healthcare and has been approved by Bellberry Human Research ethics committee. Participants will self-collect their specimen samples once a week for four weeks. A total of four tests. This was done to determine whether participants find this method of testing acceptable and to ensure that they are COVID negative before they present to Icon Cancer Centre for their cancer treatment. Each participant will be followed for four weeks in total. During this time they will complete a daily symptom and temperature diary , this will be emailed to participants each day for 28 days from the day of their first self-collected COVID-19 specimen and will self-collect specimens once a week for four weeks. The intention of this study is to have patients self-collect in their own homes, this will be unsupervised by medical professionals however, if a participant has symptoms of COVID-19 they will be encouraged to seek additional testing performed by a healthcare professional. In addition, Any participant who has COVID like symptoms who tests negative will be asked to present for re-testing performed by a trained healthcare professional to ensure they are not producing a false negative by incorrect self-collecting techniques. Participants will be required to complete a symptom and temperature diary (this will take approximately 1-2 minutes each day for 28 days). The questions they will be asked: 1. What is your temperature today? 2. Do you have an respiratory symptoms (sore throat, cough, difficulty breathing) 3. Have you started taking any new medication in the past week? If so, please specify. At the end of the four weeks, patients will be sent a short survey (not validated) asking them to rate their experience (Likert scale) and provide any feedback they would like to provide to the study team (free text) - this is expected to take approximately 5 minutes to complete. How to self-collect for covid-19 instructions can be found here https://www.snp.com.au/media/11821/item-q02228-covid-19rsp-self-collection-patient-kit-web-instructions-202009.pdf
Sponsors
Icon Cancer Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient is clinically and pathologically diagnosed with cancerous malignancy • Patient is receiving active treatment for their cancer at one of the participating Icon Cancer Centre’s • Patient is 18 years or older • Patient is capable of performing all protocol-related procedures (including the ability to return the sample to Sonic HealthCare laboratory) • Patient or legal representative capable of giving written and signed informed consent prior to performing any protocol-related procedures
Exclusion criteria
• Patients who decline to perform self-collected test • Patients who have undergone nasal surgery in the past 2 weeks • Patients with acute facial trauma
Outcome results
None listed