Breast Reconstruction Following Breast Cancer in Very High Risk Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to:
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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
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Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Endpoint(s)
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Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort
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Compare immediate and delayed reconstruction outcome metrics through retrospective review
Secondary Endpoint(s)
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Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction.
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Compare complications and reoperations between immediate versus delayed reconstruction.
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Compare the hospital costs between immediate versus delayed reconstruction
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Evaluate the effectiveness of risk reduction strategies
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Immediate 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. |
Procedure: Immediate Breast Reconstruction
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.
Other: Breast-Q questionnaire
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
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| Experimental: Delayed breast reconstruction 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
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.
Other: Breast-Q questionnaire
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
|
Outcome Measures
Primary Outcome Measures
- optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications [Until 1 year post breast reconstruction]
Proportion of patients preferring delayed reconstruction.
Secondary Outcome Measures
- Major complications [Until 1 year post breast reconstruction]
defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
- Minor complications [Until 1 year post breast reconstruction]
defined as the ones that were office treated, not requiring a reoperation
- Number of revision surgeries [Until 1 year post breast reconstruction]
defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
- Hospital cost of the complete reconstruction treatment [Until 1 year post breast reconstruction]
Cost of reconstruction including the cost of complications
- Change in patient satisfaction [Until 1 year post breast reconstruction]
Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up
Other Outcome Measures
- Aesthetic evaluation [Until 1 year post breast reconstruction]
Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
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Subjects must be breast reconstruction candidates using implant based breast reconstruction.
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Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
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Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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Prior breast cancer surgical treatment
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Prior breast reconstruction
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Inability to provide written consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Principal Investigator: Risal Djohan, MD, Cleveland Clinic, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE10116