Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic and quality of life outcomes.

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000078651

Enrollment

Registered

2014-01-22

Start date

2012-05-29

Completion date

2014-08-06

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results