Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Breast Cancer; Malignant Neoplasm of Breast

Treatments: Procedure: Immediate Breast Reconstruction; Other: Breast-Q questionnaire; Procedure: Delayed Breast Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03261323

CASE10116

Details and patient eligibility

About

The purpose of this study is to:

1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs
2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Full description

Primary Endpoint(s)

1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
2. Compare immediate and delayed reconstruction outcome metrics through retrospective review

Secondary Endpoint(s)

1. Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
2. Compare complications and reoperations between immediate versus delayed reconstruction.
3. Compare the hospital costs between immediate versus delayed reconstruction
4. Evaluate the effectiveness of risk reduction strategies

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Immediate breast reconstruction

Active Comparator group

Description:

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.

Treatment:

Procedure: Immediate Breast Reconstruction

Other: Breast-Q questionnaire

Delayed breast reconstruction

Experimental group

Description:

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.

Treatment:

Procedure: Delayed Breast Reconstruction

Other: Breast-Q questionnaire