Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000048886
Ethics application status
Approved
Date submitted
9/12/2020
Date registered
19/01/2021
Date last updated
8/11/2022
Date data sharing statement initially provided
19/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility and efficacy of self-collected nasopharyngeal specimens for COVID-19 detection in an Australian oncology population
Scientific title
The feasibility and efficacy of self-collected nasopharyngeal specimens for COVID-19 detection in an Australian oncology population
Secondary ID [1] 302989 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 320041 0
Cancer 320332 0
Condition category
Condition code
Infection 317967 317967 0 0
Other infectious diseases
Respiratory 318043 318043 0 0
Other respiratory disorders / diseases
Cancer 318044 318044 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 319276 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325976 0
To assess the feasibility of home COVID-19 testing prior to oncology clinical care presentation.

For the purpose of this study, feasibility will be assessed in relation to:
1. acceptability by the proportion of eligible patients who agree to participate as determined by audit of study database.
2. Implementation by the proportion of participants who comply adequately with the self-sampling procedure as determined by audit of study database.
Timepoint [1] 325976 0
4 weeks post enrollment
Primary outcome [2] 325977 0
To determine the incidence of positive COVID-19 testing in an ambulant oncology population by PCR analysis.

Any positive result will be treated with urgency and patient will be asked to immediately self-isolate until they receive further testing performed by a healthcare professional as per state guidelines.

Previous assessment of self-collection of swabs for SARS-CoV-2 and other respiratory viruses have shown that self-collection methods are at least equivalent to health worker collected swabs and therefore to show adequate implementation, it would be expected that all positive self-collect test results will match results of healthcare worker collected swabs.
Timepoint [2] 325977 0
4 weeks post enrollment
Primary outcome [3] 325978 0
To determine the incidence of COVID-19 associated respiratory symptoms in this population across the period of the study.
this will be assessed by participants completing a daily symptom and temperature diary.
Timepoint [3] 325978 0
4 weeks post enrollment
Secondary outcome [1] 389731 0
To determine study compliance by the proportion of eligible patients who comply with all study requirements including correct self-collection of samples, sample drop off and daily diary completion.
Participant survey data is being collected in real time by REDCap database and will be cross referenced through sonic database to ensure all study procedures were met, where there are discrepancies or missed procedures, this will be reported in the findings of the study.
Timepoint [1] 389731 0
4 weeks post enrollment
Secondary outcome [2] 389732 0
To determine the testing failure rate due to incorrect self-directed swabs.
This will be determined by no genetic material present on swab by PCR analysis
Timepoint [2] 389732 0
4 weeks post enrollment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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


Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All data will be screened for consistency and errors before analysis. The primary measures in this study are proportions and rates. Estimates of these statistics will include margins of error and comparisons made across sites using appropriate inferential methods. Diary data will be summarised, displayed and analysed as applicable for the scale of variables involved. The analysis will make use of R (R Core Team, 2020).

Statistical power: Active patient numbers for August, 2020 at each site provide estimates of the anticipated numbers of patients invited to participate in the study. These numbers are 843, 682, 93 and 89 for Wesley, South Brisbane, Richmond and Wahronga respectively. The key statistics of interest are proportions (viz, participation, compliance and failure rates). Differences amongst the sites based on a chi square test of homogeneity at the 5% level of significance can be expected to detect a small difference (w = 0.1 in the sense of Cohen, 1977) in proportions amongst the four sites with at least 90% power. More specifically, a difference of 3% between any two of the sites is expected to be detectable with 80% power. If no differences are detected amongst sites, relevant proportions can be expected to be estimated to within 3% (assuming 75% or better participation, compliance and success rates) at the 95% level of confidence. If differences are detected, at worst relevant proportions can be expected to be estimated to within 12% (assuming 75% or better participation, compliance and success rates) at the 95% level of confidence.
This power analysis makes use of R (R Core Team, 2020) and the package pwr (Champely, 2020).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
29/01/2021
Actual
19/02/2021
Date of last data collection
Anticipated
26/02/2021
Actual
10/04/2021
Sample size
Target
274
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 18175 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [2] 18176 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [3] 18177 0
Icon Cancer Centre Richmond - Richmond
Recruitment postcode(s) [1] 32184 0
4101 - South Brisbane
Recruitment postcode(s) [2] 32185 0
4066 - Auchenflower
Recruitment postcode(s) [3] 32186 0
3121 - Richmond
Recruitment postcode(s) [4] 32188 0
2076 - Wahroonga
Recruitment postcode(s) [5] 32189 0
4509 - North Lakes

Funding & Sponsors
Funding source category [1] 307398 0
Charities/Societies/Foundations
Name [1] 307398 0
Icon Cancer foundation
Country [1] 307398 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Icon Cancer Centre
Address
level 1 and 5, 22 Cordellia street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 308058 0
Commercial sector/Industry
Name [1] 308058 0
Sonic Healthcare
Address [1] 308058 0
14 Giffnock Avenue
Macquarie Park NSW 2113
Australia
Country [1] 308058 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307485 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307485 0
Ethics committee country [1] 307485 0
Australia
Date submitted for ethics approval [1] 307485 0
29/07/2020
Approval date [1] 307485 0
07/10/2020
Ethics approval number [1] 307485 0
2020-07-710

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107398 0
Dr John Bashford
Address 107398 0
Icon Cancer Centre corporate office - level 1 and 5, 22 Cordelia street, South Brisbane, QLD 4101
Country 107398 0
Australia
Phone 107398 0
+61 3737 4561
Fax 107398 0
Email 107398 0
[email protected]
Contact person for public queries
Name 107399 0
Mel Grand
Address 107399 0
Icon Cancer Centre corporate office - level 1 and 5, 22 Cordelia street, South Brisbane, QLD 4101
Country 107399 0
Australia
Phone 107399 0
+61 0437067494
Fax 107399 0
Email 107399 0
[email protected]
Contact person for scientific queries
Name 107400 0
Mel Grand
Address 107400 0
Icon Cancer Centre corporate office - level 1 and 5, 22 Cordelia street, South Brisbane, QLD 4101
Country 107400 0
Australia
Phone 107400 0
+61 0437067494
Fax 107400 0
Email 107400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient sensitive information will not be shared publically


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.