Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000078651
Ethics application status
Approved
Date submitted
15/01/2014
Date registered
22/01/2014
Date last updated
22/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic and quality of life outcomes.
Scientific title
A retrospective observational study of women with breast cancer who have had mastectomy, immediate breast reconstruction and post-mastectomy radiotherapy (PMRT), and one-off assessment at six months post-stage 2 reconstruction, of aesthetic and quality of life outcomes.
Secondary ID [1] 283873 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 290857 0
Condition category
Condition code
Cancer 291218 291218 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
Six
Target follow-up type
Months
Description of intervention(s) / exposure
Quality of life and aesthetic outcomes in women following mastectomy, immediate breast reconstruction and PMRT, as measured by a one-off set of surveys six months after second-stage reconstruction. A subset of these women will also have a clinical examination and photos taken, at a minimum of six months post-stage 2 reconstruction, as part of their routine follow up.
Intervention code [1] 288548 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291212 0
To assess the psychological and quality of life outcomes of patients undergoing mastectomy, immediate reconstruction and PMRT through the following surveys:
Breast Q - reconstruction module (post operative)
Body Image Scale
Impact of Event Scale
Decision Regret Scale
FACT-B
Timepoint [1] 291212 0
Six months following second-stage reconstruction.
Primary outcome [2] 291308 0
To assess the surgical, radiotherapy and oncological outcomes of patients undergoing mastectomy, immediate reconstruction and PMRT through patient records and clinical examination.
Timepoint [2] 291308 0
Six months following second-stage reconstruction.
Primary outcome [3] 291309 0
To assess the aesthetic outcomes of patients undergoing mastectomy, immediate reconstruction and PMRT through patient surveys (Breast Q). In addition, a sub-set of these women will have a clinical assessment form completed by the surgeon and photos taken.
Timepoint [3] 291309 0
A minimum of six months following second-stage reconstruction.
Secondary outcome [1] 306245 0
To report types of breast reconstruction chosen by women undergoing post-mastectomy radiotherapy.
Timepoint [1] 306245 0
At end of final breast reconstruction.

Eligibility
Key inclusion criteria
1) Female gender
2) Undergoing mastectomy for breast cancer (unilateral or bilateral)
3) Undergoing immediate reconstruction with implant/tissue expander
4) Undergoing post-mastectomy radiotherapy
5) Willing to give written informed consent.
6) Willingness to participate to and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Male
2. Women unable to read and write English to a level required for completion of informed consent form and questionnaires.
3. Women unwilling to give consent for the study.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample size will be determined by the number of eligible patients identified from the database, but a sample size of 50 is anticipated. Descriptive statistics will be used to analyse and describe the data obtained from questionnaires and surgeon aesthetic ratings.
The questionnaires are all standardised and validated, and will be scored according to standard scoring criteria published in the literature. Comparison of subgroups may be possible in some cases, for example if there are variations in dose of radiation, aesthetic and psychological outcomes at different doses will be analysed. Options for analysis of outcomes in different age groups and body habitus may also be explored.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2012
Actual
29/05/2012
Date of last participant enrolment
Anticipated
29/08/2014
Actual
6/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1941 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 7684 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 288518 0
Hospital
Name [1] 288518 0
Mater Hospital
Country [1] 288518 0
Australia
Primary sponsor type
Other
Name
Breast & Surgical Oncology at the Poche Centre
Address
40 Rocklands Rd, North Sydney
NSW 2060
Country
Australia
Secondary sponsor category [1] 287224 0
None
Name [1] 287224 0
Address [1] 287224 0
Country [1] 287224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290382 0
St Vincent's Hospital
Ethics committee address [1] 290382 0
390 Victoria St,
Darlinghurst, NSW, 2010.
Ethics committee country [1] 290382 0
Australia
Date submitted for ethics approval [1] 290382 0
Approval date [1] 290382 0
19/12/2011
Ethics approval number [1] 290382 0
11/156

Summary
Brief summary
This study will assess the quality of life of women from a surgical oncology practice in North Sydney, Australia, who have undergone mastectomy for breast cancer, have chosen to have immediate breast reconstruction (IBR) and have also required post-mastectomy radiotherapy (PMRT). The purpose of this research is to provide evidence about the oncological safety and levels of patient satisfaction in this group of women.

Study details
All participants in this study will be asked to complete five surveys, six months after their final breast reconstruction operation, about their satisfaction with the aesthetic outcomes of their surgery, and its affect on their psychological wellbeing and quality of life. These patient-reported outcomes will be assessed alongside measures of their clinical outcomes, including any post-operative or post-radiotherapy complications, taken from their patient record. A subset of these women will also have a clinical examination and photos taken at six months following their final reconstruction procedure.
Trial website
Trial related presentations / publications
The following journal article is under review with Plastic and Reconstructive Surgery. Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic, surgical, satisfaction and quality of life outcomes in women with high-risk breast cancer.
Public notes

Contacts
Principal investigator
Name 45406 0
A/Prof Andrew Spillane
Address 45406 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd, North Sydney,
NSW 2060.
Country 45406 0
Australia
Phone 45406 0
+61 2 99117381
Fax 45406 0
Email 45406 0
andrew.spillane@melanoma.org.au
Contact person for public queries
Name 45407 0
Dr Kathy Flitcroft
Address 45407 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd, North Sydney,
NSW 2060.
Country 45407 0
Australia
Phone 45407 0
+61 2 99117381
Fax 45407 0
Email 45407 0
kathy.flitcroft@melanoma.org.au
Contact person for scientific queries
Name 45408 0
Dr Meagan Brennan
Address 45408 0
Breast & Surgical Oncology at The Poche Centre
40 Rocklands Rd, North Sydney,
NSW 2060.
Country 45408 0
Australia
Phone 45408 0
+61 2 99117381
Fax 45408 0
Email 45408 0
meagan.brennan@sydney.edu.au

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.