ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast cancer

COVID-19

Condition category

Condition code

Cancer

Breast

Public Health

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]

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]

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]

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]

'COVID-related change from ideal treatment' This is a yes/no outcome.

Timepoint [2]

Documented at the time of the MDT discussion of treatment options. Information will be collected in realtime or from medical records.

Secondary outcome [1]

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]

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]

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]

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]

Radiotherapy: 'COVID-related change from ideal treatment' This is a yes/no outcome.

Timepoint [3]

Documented at the time of the MDT discussion of treatment options. Information will be collected in realtime or from medical records.

Secondary outcome [4]

Chemotherapy: 'COVID-related change from ideal treatment' This is a yes/no outcome.

Timepoint [4]

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?

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]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Westmead Breast Cancer Institute

Address [1]

Level 1, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney LHD Human Ethics Committee

Ethics committee address [1]

Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/04/2020

Approval date [1]

23/04/2020

Ethics approval number [1]

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

A/Prof Meagan Brennan

Address

Westmead Breast Cancer Institute, Level 1, Hawkesbury Rd, Westmead Hospital, NSW 2145 Australia

Country

Australia

Phone

+61 2 8890 6728

Fax

meagan.brennan1@health.nsw.gov.au

Contact person for public queries

Name

Meagan Brennan

Address

Westmead Breast Cancer Institute, Level 1, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145, Australia

Country

Australia

Phone

+61 2 8890 6728

Fax

meagan.brennan1@health.nsw.gov.au

Contact person for scientific queries

Name

Meagan Brennan

Address

Westmead Breast Cancer Institute, Level 1, Westmead Hospital, Hawkesbury Rd, Westmead NSW 2145 Australia

Country

Australia

Phone

+61 2 8890 6728

Fax

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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