Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000869976
Ethics application status
Approved
Date submitted
25/08/2020
Date registered
31/08/2020
Date last updated
12/04/2022
Date data sharing statement initially provided
31/08/2020
Date results information initially provided
31/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Management of early breast cancer during the COVID-19 pandemic: Single institution experience
Scientific title
Management of early breast cancer during the COVID-19 pandemic: Single institution experience
Secondary ID [1] 302140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 318772 0
COVID-19 318773 0
Condition category
Condition code
Cancer 316786 316786 0 0
Breast
Public Health 316843 316843 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will compare the ‘ideal, evidence-based treatment’ that would have been delivered pre-COVID to the care that is actually delivered, given the restrictions, during the COVID pandemic. The multidisciplinary team will document the recommended treatment (COVID-restricted) for each patient that is discussed. At the same time, the team will document what the 'ideal' treatment would have been without COVID restrictions.

This is an observational trial, so no action is required from participants. Participants will be informed of the ideal treatment and the changes resulting from COVID restrictions. This will be documented and discussed with the participant each time their case is discussed by the MDT. On average, this is once or twice, depending on the sequencing of treatment and complexity of the case. Cases treated according to 'ideal' management will not be followed-up. Those receiving treatment altered by the pandemic will be identified by this study and followed-up at 3-monthly intervals until this is deemed no longer needed according to MDT recommendations.
Intervention code [1] 318437 0
Not applicable
Comparator / control treatment
This study will prospectively collect data from the multidisciplinary breast cancer team about patient treatment during the COVID-19 pandemic. This will be compared to what the 'ideal' treatment would have been without COVID-related restrictions.
Control group
Active

Outcomes
Primary outcome [1] 324903 0
Treatment for breast cancer- surgical management. Assessed by documenting the MDT recommendation for surgery for each participant. The possible categories are 'wide local excision' or 'simple mastectomy' or 'mastectomy and reconstruction.'
Timepoint [1] 324903 0
First MDT discussion of NEW or post-neoadjuvant cancer- single timepoint at discussion in MDT. To be collected in real-time during MDT discussion or later from medical record.
Primary outcome [2] 324971 0
'COVID-related change from ideal treatment' This is a yes/no outcome.
Timepoint [2] 324971 0
Documented at the time of the MDT discussion of treatment options. Information will be collected in realtime or from medical records.
Secondary outcome [1] 386171 0
Treatment for breast cancer- Radiotherapy.
Assessed by documenting the MDT recommendation for RT for each participant. The possible categories are 'breast only' or 'breast and axilla' or 'chest wall only' or 'chest wall and axilla' or 'none'.
Timepoint [1] 386171 0
At POST-OP MDT discussion. Single timepoint at discussion in MDT. To be collected in real-time during MDT discussion or later from medical record.
Secondary outcome [2] 386328 0
Treatment for breast cancer- Chemotherapy
Assessed by documenting the MDT recommendation for RT for each participant. The possible categories are 'neoadjuvant chemo' or 'adjuvant chemo' or 'none'.

Timepoint [2] 386328 0
At POST-OP MDT discussion. Single timepoint at discussion in MDT. To be collected in real-time during MDT discussion or later from medical record.
Secondary outcome [3] 386379 0
Radiotherapy: 'COVID-related change from ideal treatment' This is a yes/no outcome.
Timepoint [3] 386379 0
Documented at the time of the MDT discussion of treatment options. Information will be collected in realtime or from medical records.
Secondary outcome [4] 386380 0
Chemotherapy: 'COVID-related change from ideal treatment' This is a yes/no outcome.
Timepoint [4] 386380 0
Documented at the time of the MDT discussion of treatment options. Information will be collected in realtime or from medical records.

Eligibility
Key inclusion criteria
All new cases of early breast cancer presenting to WBCI and discussed through one of the three multidisciplinary cancer teams (MDTs) will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cases of advanced (metastatic) breast cancer.
2. Cases of locally recurrent breast cancer.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data management

Data will be kept in an Excel and/or SPSS database. This will be stored on a password protected network at the WBCI.


Statistical methods

Number of cases will be determined by number of new cases of early breast cancer referred to the breast MDT for management during the pandemic.
Descriptive statistics will be used to describe the cases and the cancer treatments, both ‘ideal’ and ‘best possible.’
Chi-square and/or t-tests may be used to compare treatment differences in subgroups, as indicated by the data. Subgroup analysis may include: comparison of treatments by age group and comparison of treatments by ER/PR and HER2

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/04/2020
Date of last participant enrolment
Anticipated
Actual
15/06/2020
Date of last data collection
Anticipated
18/09/2020
Actual
2/10/2020
Sample size
Target
150
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17327 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 31055 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306565 0
Other
Name [1] 306565 0
Westmead Breast Cancer Institute
Country [1] 306565 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Westmead Breast Cancer Institute, Level 1, Westmead Hospital, Hawkesbury Rd, Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 307089 0
None
Name [1] 307089 0
Address [1] 307089 0
Country [1] 307089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306750 0
Western Sydney LHD Human Ethics Committee
Ethics committee address [1] 306750 0
Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145
Ethics committee country [1] 306750 0
Australia
Date submitted for ethics approval [1] 306750 0
05/04/2020
Approval date [1] 306750 0
23/04/2020
Ethics approval number [1] 306750 0
2020/PID00900

Summary
Brief summary
This study will compare the ‘best possible’ treatment delivered during the COVID-19 pandemic to ‘ideal’ treatment before the pandemic for newly diagnosed early breast cancer patients

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have been newly diagnosed with early breast cancer at Westmead Breast Cancer Institute during the COVID-19 pandemic and discussed by the Westmead multidisciplinary cancer team (MDT) between March and June 2020.

Study details
MDTs, consisting of surgeons, medical oncologists, radiation oncologists, pathologists, breast physicians, genetic oncologists and other specialty representatives, will discuss and assess participants’ ‘ideal’ and ‘best possible’ treatment options at team meetings.

All participants assessed by an MDT will have discussions about the ‘ideal’ and ‘best possible’ treatment with their treating specialist. The reasons for any treatment that varies from ideal will be explained to the participant. When the COVID-19 pandemic finishes, the participant will be recalled to discuss further treatment if their treatment differed from the 'ideal.'

At various stages of treatment, the MDTs will meet and assess participants’ treatment options. All discussions and treatment delivered will be documented in medical records.

It is hoped that this research will give insight into the challenges that the COVID-19 pandemic has presented for breast cancer treatment. It will also identify participants who have not had ideal treatment and they can be followed closely in the future.
Trial website
None
Trial related presentations / publications
None
Public notes
Eligible participants were treated for breast cancer and discussed in an MDT between 15/3/2020 to 15/6/2020. The ethics approval was obtained on 23/04/2020. Therefore, participants were registered and data collected retrospectively for participants discussed in the MDT meeting before 23/04/2020 and prospectively for participants discussed in the MDT meeting after 23/04/2020.

Contacts
Principal investigator
Name 104898 0
A/Prof Meagan Brennan
Address 104898 0
Westmead Breast Cancer Institute, Level 1, Hawkesbury Rd, Westmead Hospital, NSW 2145 Australia
Country 104898 0
Australia
Phone 104898 0
+61 2 8890 6728
Fax 104898 0
Email 104898 0
meagan.brennan1@health.nsw.gov.au
Contact person for public queries
Name 104899 0
Meagan Brennan
Address 104899 0
Westmead Breast Cancer Institute, Level 1, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145, Australia
Country 104899 0
Australia
Phone 104899 0
+61 2 8890 6728
Fax 104899 0
Email 104899 0
meagan.brennan1@health.nsw.gov.au
Contact person for scientific queries
Name 104900 0
Meagan Brennan
Address 104900 0
Westmead Breast Cancer Institute, Level 1, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145 Australia
Country 104900 0
Australia
Phone 104900 0
+61 2 8890 6728
Fax 104900 0
Email 104900 0
meagan.brennan1@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who requests access
Available for what types of analyses?
any purpose
How or where can data be obtained?
Available via Mendeley Data Repository online https://data.mendeley.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.