Breast Reconstruction Following Breast Cancer in Very High Risk Patients
Breast Cancer, Malignant Neoplasm of Breast
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Reconstruction, Mastectomy
Eligibility Criteria
Inclusion Criteria:
- Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
- Subjects must be breast reconstruction candidates using implant based breast reconstruction.
- Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior breast cancer surgical treatment
- Prior breast reconstruction
- Inability to provide written consent
Sites / Locations
- Cleveland Clinic, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Immediate breast reconstruction
Delayed breast reconstruction
The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.