Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000188437
Ethics application status
Approved
Date submitted
9/02/2016
Date registered
12/02/2016
Date last updated
20/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Breast Reconstruction Equity of Access through Stakeholder consultation and Translation into policy and practice (I-BREAST).
Scientific title
Improving Breast Reconstruction Equity of Access through Stakeholder consultation and Translation into policy and practice (I-BREAST).
Secondary ID [1] 288509 0
None
Universal Trial Number (UTN)
Trial acronym
I-BREAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 297577 0
Breast reconstruction 297578 0
Condition category
Condition code
Cancer 297774 297774 0 0
Breast
Public Health 297796 297796 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
Interviews using semi-structured questionnaires will be conducted with women with breast cancer, breast care nurses and breast/plastic surgeons to evaluate barriers and enablers in accessing breast reconstruction in their local areas. Some state- and national-level decision makers (clinical and policy) will also be interviewed to look at current policy and potential obstacles to change. This project will take a 'snapshot' approach, capturing participants' experiences with breast reconstruction as reported in 2016-2017, with no ongoing follow up of participants.
Intervention code [1] 293870 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297300 0
To assess general issues around access to breast reconstruction following mastectomy for breast cancer. This will be assessed through interviews with women with breast cancer, breast care nurses and breast/plastic surgeons.
Timepoint [1] 297300 0
Snapshot of participants' experiences of breast reconstruction, as reported in 2016-2017.
Primary outcome [2] 297301 0
To assess reasons behind regional variation in breast reconstruction practice. This will be assessed by comparing data on breast reconstruction practice in particular areas with the views of local women with breast cancer, breast care nurses and breast/plastic surgeons through interviews.
Timepoint [2] 297301 0
2016-2017
Primary outcome [3] 297321 0
To make recommendations, based on our findings, on the best ways to overcome barriers to accessing breast reconstruction for all clinically eligible women who wish to have it.
Timepoint [3] 297321 0
2016-2017
Secondary outcome [1] 320664 0
To determine any patterns in facilitators and barriers to accessing breast reconstruction that impact on several regions across Australia. This will be assessed through interviews with women with breast cancer, breast care nurses and breast/plastic surgeons as well as with clinical and policy decision-makers.
Timepoint [1] 320664 0
2016-2017
Secondary outcome [2] 320727 0
To determine any specific facilitators and barriers to accessing breast reconstruction that are unique to certain parts of Australia. This will be assessed through a closer examination of local factors that may impact on the provision of breast reconstruction services.
Timepoint [2] 320727 0
2016-2017

Eligibility
Key inclusion criteria
Women who have undergone mastectomy for breast cancer.
Breast care nurses who have looked after women who have undergone mastectomy for breast cancer.
Breast and plastic surgeons who operate on women who require mastectomy for breast cancer.
Clinical and policy decision-makers who have potential input into training of breast surgeons and/or funding of breast reconstruction surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable/unwilling to be interviewed

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Not applicable

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
1/05/2017
Date of last data collection
Anticipated
Actual
4/05/2017
Sample size
Target
80
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7581 0
Ireland
State/province [1] 7581 0

Funding & Sponsors
Funding source category [1] 292858 0
Charities/Societies/Foundations
Name [1] 292858 0
Friends of the Mater Foundation
Country [1] 292858 0
Australia
Primary sponsor type
Hospital
Name
Mater Hospital, Sydney
Address
Rocklands Rd,
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 291603 0
None
Name [1] 291603 0
Address [1] 291603 0
Country [1] 291603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294357 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 294357 0
390 Victoria St
Darlinghurst
NSW 2010
Ethics committee country [1] 294357 0
Australia
Date submitted for ethics approval [1] 294357 0
22/07/2014
Approval date [1] 294357 0
03/09/2014
Ethics approval number [1] 294357 0
14/181

Summary
Brief summary
The primary purpose of this study is to systematically explore factors behind the low and uneven rates of breast reconstruction across Australia, It aims to identify practical ways to improve equity of access for women regardless of where they live, their age and ethnic/cultural backgrounds. It will produce acceptable, feasible and readily-translatable recommendations for practice and policy changes to address disparities in women’s breast reconstruction options. Who is it for? You may be eligible to participate in this study if you are a woman who has had mastectomy for breast cancer, a breast care nurse, a breast or plastic surgeon or a clinical or policy person involved in making decisions about breast reconstruction. Study details: The study will primarily involve one-off interviews, either face-to-face or by telephone, with eligible participants. It is hoped that the findings of this study will provide recommendations for practice and policy changes which improve the equity of access to breast reconstruction in Australia.
Trial website
Not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63410 0
Dr Kathy Flitcroft
Address 63410 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 63410 0
Australia
Phone 63410 0
+61 2 9911 7312
Fax 63410 0
Email 63410 0
[email protected]
Contact person for public queries
Name 63411 0
Kathy Flitcroft
Address 63411 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 63411 0
Australia
Phone 63411 0
+61 2 9911 7312
Fax 63411 0
Email 63411 0
[email protected]
Contact person for scientific queries
Name 63412 0
Kathy Flitcroft
Address 63412 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd
North Sydney NSW 2060
Country 63412 0
Australia
Phone 63412 0
+61 2 9911 7312
Fax 63412 0
Email 63412 0
[email protected]

No information has been provided regarding IPD availability


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.