Mastectomy Reconstruction Outcomes Consortium (MROC) Study (MROC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01723423|
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : July 13, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||4436 participants|
|Official Title:||Mastectomy Reconstruction Outcomes Consortium (MROC) Study|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Patients receiving expander/implant breast reconstruction procedures.
Patients receiving latissimus dorsi breast reconstructions with or without implant.
Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction.
Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.)
Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions.
Patients receiving superficial inferior epigastric artery (SIEA)breast reconstruction.
Patients receiving superior gluteal artery perforator breast reconstruction.
Patients receiving inferior gluteal artery perforator breast reconstruction.
- Change from baseline in health-related quality of life. [ Time Frame: Change from baseline at 1 week, 3 months, 1 year and 2 years post-operatively. ]Patient reported outcome measures will include patient satisfaction, post-operative pain, body image, psycho-social functioning, physical functioning, and fatigue.
- The effects of race and ethnicity on reconstruction outcomes. [ Time Frame: Pre-operatively and at 1 week, 3 months, 1 year and 2 years postoperatively ]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.
- Descriptive statistics on the relative costs of the eight procedure types. [ Time Frame: 2 years postoperatively ]Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723423
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, D.C., District of Columbia, United States, 20007|
|United States, Georgia|
|Georgia Institute for Plastic Surgery|
|Savannah, Georgia, United States, 31405|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611-2923|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan Medical Center|
|Ann Arbor, Michigan, United States, 48109|
|St. Joseph's Mercy Health System|
|Ann Arbor, Michigan, United States, 48197|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43212-3154|
|United States, Texas|
|M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Canada, British Columbia|
|Providence Health Care - University of British Columbia|
|Vancouver, British Columbia, Canada|
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||Edwin G Wilkins, MD, MS||University of Michigan|
|Principal Investigator:||Andrea L. Pusic, MD, MHSA||Memorial Sloan Kettering Cancer Center|