Choice of breast reconstruction (immediate, delayed or none) and quality of life for women undergoing mastectomy and radiotherapy for breast cancer.

Not Applicable

Completed

• Conditions: Breast cancer; Cancer - Breast

• Registration Number: ACTRN12614000045617
• Lead Sponsor: Breast & Surgical Oncology at The Poche Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-17
• Study Completion: 2021-07-26
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

1. Diagnosed with breast cancer requiring mastectomy and likelihood of requiring PMRT.
2. Neo-adjuvant chemotherapy treated patients who are having mastectomy and planned for PMRT.
3. Able and willing to complete study questionnaires
4. Able to provide written & informed consent to participate in study.

Exclusion Criteria

1. Prophylactic or risk-reducing surgery
2. Previous radiotherapy to the breast or chest precluding standard radiotherapy
3. Planned radiotherapy dose of <50Gy
4. Loco-regional recurrence precluding further radiotherapy
5. Previous wide local excision requiring completion mastectomy without the need for PMRT
6. Pregnant women
7. Distant metastatic disease
8. Inflammatory breast cancer

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the quality of life of patients undergoing immediate, delayed or no reconstruction. The following validated tools are used in this assessment:<br>EORTC QLQ - C30<br>EORTC QLQ - BR23<br>Breast Q (mastectomy and reconstruction models, pre and post-op)<br>Body Image after Breast Cancer<br>Brief Pain Inventory<br>Pain Catastrophizing Scale<br>[Baseline and at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-mastectomy.]