Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: 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 Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Detailed Description
-----------------
Primary Endpoint(s) Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort Compare immediate and delayed reconstruction outcome metrics through retrospective review Secondary Endpoint(s) Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction. Compare complications and reoperations between immediate versus delayed reconstruction. Compare the hospital costs between immediate versus delayed reconstruction Evaluate the effectiveness of risk reduction strategies

Official Title
-----------------
Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study

Conditions
-----------------
Breast Cancer, Malignant Neoplasm of Breast

Intervention / Treatment
-----------------
* Procedure: Immediate Breast Reconstruction
* Procedure: Delayed Breast Reconstruction
* Other: Breast-Q questionnaire


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate breast reconstruction<br>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. | Procedure: Immediate Breast Reconstruction<br>* Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.<br>Other: Breast-Q questionnaire<br>* Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment<br>|
| Experimental: Delayed breast reconstruction<br>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. | Procedure: Delayed Breast Reconstruction<br>* Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.<br>Other: Breast-Q questionnaire<br>* Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications | Proportion of patients preferring delayed reconstruction. | Until 1 year post breast reconstruction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications | defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc). | Until 1 year post breast reconstruction | 
| Minor complications | defined as the ones that were office treated, not requiring a reoperation | Until 1 year post breast reconstruction | 
| Number of revision surgeries | defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal | Until 1 year post breast reconstruction | 
| Hospital cost of the complete reconstruction treatment | Cost of reconstruction including the cost of complications | Until 1 year post breast reconstruction | 
| Change in patient satisfaction | Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up | Until 1 year post breast reconstruction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Reconstruction, Mastectomy