Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic and quality of life outcomes.
Not Applicable
Completed
- Conditions
- Breast cancerCancer - Breast
- Registration Number
- ACTRN12614000078651
- Lead Sponsor
- Breast & Surgical Oncology at the Poche Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
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.
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the psychological and quality of life outcomes of patients undergoing mastectomy, immediate reconstruction and PMRT through the following surveys:<br>Breast Q - reconstruction module (post operative)<br>Body Image Scale<br>Impact of Event Scale<br>Decision Regret Scale<br>FACT-B<br>[Six months following second-stage reconstruction.];To assess the surgical, radiotherapy and oncological outcomes of patients undergoing mastectomy, immediate reconstruction and PMRT through patient records and clinical examination.[Six months following second-stage reconstruction.];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.[A minimum of six months following second-stage reconstruction.]
- Secondary Outcome Measures
Name Time Method To report types of breast reconstruction chosen by women undergoing post-mastectomy radiotherapy.[At end of final breast reconstruction.]