Mastectomy Reconstruction Outcomes Consortium (MROC) Study

Study Overview
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Brief Summary
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The MROC Study seeks to evaluate and compare from the patient's point of view the leading options for breast reconstruction after mastectomy. This study will help patients, physicians, payers and policy makers better understand the various surgeries available for breast reconstruction. Although many women choose reconstruction, the number of options as well as their pros and cons can make decision making difficult and stressful. From this research, we hope to learn more about what works best for patients undergoing these operations.

Detailed Description
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Despite the growing use of breast conservation as primary therapy for breast cancer, mastectomy remains a common treatment option. Many patients choose to undergo breast reconstruction as an effective means of lessening the adverse impact of mastectomy on psychosocial functioning and quality of life. Despite these benefits, well-designed studies comparing the current choices from the patient's point of view are difficult (if not impossible) to come by. Previous research on breast reconstruction outcomes has also failed to include race and ethnicity as key variables. In order to actively participate in the reconstruction decision making process, breast cancer survivors need objective, up-to-date information on breast reconstruction outcomes from the patient's perspective. The proposed Mastectomy Reconstruction Outcomes Consortium (MROC) Study will use a prospective cohort design to compare outcomes for the eight commonly used options for breast reconstruction: expander/implant, latissimus dorsi/implant (LD), pedicle transverse rectus abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), deep inferior epigastric perforator (DIEP), superficial inferior epigastric artery (SIEA), superior gluteal artery perforator (SGAP) and inferior gluteal artery perforator (IGAP) techniques. Outcomes assessed will include complications, postoperative pain, psychosocial well-being, physical functioning, fatigue, patient satisfaction and costs. The project will also evaluate the effects of race and ethnicity on reconstruction outcomes. Thirteen leading centers in the United States and Canada will participate. Together, these institutions perform over 3000 breast reconstructions annually. The five year study will evaluate patients preoperatively and at one week, three months, one year and two years following reconstruction. For data sources, the project will rely on medical and billing records, as well as a panel of generic and condition-specific patient-report outcome measures. The MROC Study will benefit a variety of stakeholders in the healthcare marketplace: The project will provide consumers, providers, payers, and policy-makers with reliable, up-to-date information on the effectiveness and relative costs of surgical options for breast reconstruction, thereby promoting a more evidence-based approach to treatment and policy decision-making. Study findings will also assist health care organizations in designing systems of care tailored to the specific needs and preferences of diverse patient populations.

Official Title
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Mastectomy Reconstruction Outcomes Consortium (MROC) Study

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who present themselves for reconstruction at one of 11 MROC centers Women undergoing one of the following types of breast reconstruction after mastectomy: tissue expander/implant, LD flap (with, or without implant), PTRAM flap, FTRAM flap, DIEP flap, S-GAP flap, I-GAP flap or SIEA flap. Immediate or delayed reconstruction Unilateral or bilateral reconstructions. Women receiving mastectomy for cancer prophylaxis, without history of breast cancer, will be eligible to participate. Exclusion Criteria: Patients electing reconstruction following complications of breast augmentation, mastopexy (breast lift), or breast reduction will not be recruited for the study. Procedures performed following previously failed attempts at breast reconstruction will be excluded from the study, due to potential confounding by these previous surgeries.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Expander/Implant<br>Patients receiving expander/implant breast reconstruction procedures. | |
| Lat Dorsi<br>Patients receiving latissimus dorsi breast reconstructions with or without implant. | |
| PTRAM<br>Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction. | |
| FTRAM<br>Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.) | |
| DIEP<br>Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions. | |
| SIEA<br>Patients receiving superficial inferior epigastric artery (SIEA)breast reconstruction. | |
| S-GAP<br>Patients receiving superior gluteal artery perforator breast reconstruction. | |
| I-GAP<br>Patients receiving inferior gluteal artery perforator breast reconstruction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health-related quality of life. | Patient reported outcome measures will include patient satisfaction, post-operative pain, body image, psycho-social functioning, physical functioning, and fatigue. | Change from baseline at 1 week, 3 months, 1 year and 2 years post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of race and ethnicity on reconstruction outcomes. | Although the study will not be adequately powered to analyze outcomes by procedure type within racial and ethnic categories, we will obtain descriptive statistics for the effects of race and ethnicity on breast reconstruction outcomes. | Pre-operatively and at 1 week, 3 months, 1 year and 2 years postoperatively | 
| Descriptive statistics on the relative costs of the eight procedure types. | Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures. | 2 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, evidence based medicine, reconstruction, mastectomy, outcomes, quality of life