Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000441819
Ethics application status
Approved
Date submitted
13/03/2021
Date registered
16/04/2021
Date last updated
16/04/2021
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Breast cancer prevalence in Australian female orthopaedic surgeons.
Scientific title
Breast cancer prevalence in Australian female orthopaedic surgeons.
Secondary ID [1] 303684 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 321088 0
Condition category
Condition code
Cancer 318890 318890 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Female Fellows of the Australian Orthopaedic Association will be asked to complete a single 30 minute survey sent via email to collect information regarding age, race/ethnicity, subspecialty, years in practice, type of practice, as well as current use of fluoroscopy, x-rays, polymethylmethacrylate (PMMA) and lead protection. Additional information related to smoking history, menstrual and reproductive history, use of hormones, mammography and history of cancer will also be collected. The information collected will help to determine the occupational risk factors for breast cancer along with other confounding factors.
Intervention code [1] 319982 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326830 0
Breast cancer prevalence as determined by study-specific survey data.
Timepoint [1] 326830 0
At the time of survey completion
Secondary outcome [1] 392825 0
Total cancer prevalence (as defined by melanomas and invasive cancers) determined by study-specific survey data.
Timepoint [1] 392825 0
At the time of survey completion

Eligibility
Key inclusion criteria
All those who identify as female Fellows of the Australian Orthopaedic Association will be eligible for inclusion in this study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those doctors who are currently enrolled in training or pre-training and are not yet classified as Fellows will be excluded.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Responses will be exported to SPSS following closure of the survey. The percent counts of respondents selecting each categorical response will be analysed for trends and statistical significance using chi-square tests. Logistic regression will be performed to determine the impact of variables on each other. Descriptive continuous variables (such as age) will be presented as a mean and standard deviation. Sample size is set by the maximum number of those eligible to partake in this study, which are the registered female Fellows of the Australian Orthopaedic Association (~n = 50).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2021
Actual
Date of last participant enrolment
Anticipated
7/06/2021
Actual
Date of last data collection
Anticipated
7/06/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308102 0
University
Name [1] 308102 0
Bond University
Country [1] 308102 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 308849 0
None
Name [1] 308849 0
Address [1] 308849 0
Country [1] 308849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308088 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 308088 0
14 University Dr, Robina QLD 4226
Ethics committee country [1] 308088 0
Australia
Date submitted for ethics approval [1] 308088 0
05/11/2020
Approval date [1] 308088 0
25/02/2021
Ethics approval number [1] 308088 0
LS00157

Summary
Brief summary
Breast cancer is a common cancer diagnosed among females in Australia. Studies have demonstrated there may be an increased risk of radiation exposure in certain occupations.

The primary aim of this research is to determine if breast cancer prevalence differs among female orthopaedic surgeons from that of the general population in Australia.

Who is it for?
You may be eligible for this study if you are a female who is a Fellow of the Australian Orthopaedic Association.

Study details

All participants in this study will be invited to complete one 30-minute survey where they will complete questions regarding their occupational history and medical history.

It is hoped that this study will help determine what the prevalence of breast cancer is within Australian female orthopaedic surgeons.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109490 0
Dr Larissa Sattler
Address 109490 0
Bond University
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 109490 0
Australia
Phone 109490 0
+61406537395
Fax 109490 0
Email 109490 0
lsattler@bond.edu.au
Contact person for public queries
Name 109491 0
Dr Larissa Sattler
Address 109491 0
Bond University
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 109491 0
Australia
Phone 109491 0
+61406537395
Fax 109491 0
Email 109491 0
lsattler@bond.edu.au
Contact person for scientific queries
Name 109492 0
Dr Larissa Sattler
Address 109492 0
Bond University
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 109492 0
Australia
Phone 109492 0
+61406537395
Fax 109492 0
Email 109492 0
lsattler@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the small eligible population size and the sensitive information being collected, there is the possibility of re-identification of individuals who participate in this research.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11007Ethical approval    381608-(Uploaded-13-03-2021-16-07-52)-Study-related document.pdf



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.