Mastectomy Reconstruction Outcomes Consortium (MROC) Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Mastectomy Reconstruction Outcomes Consortium (MROC) Study|
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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 (S-GAP) breast reconstruction.
Patients inferior gluteal artery perforator (I-GAP) breast reconstruction.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723423
|Contact: Edwin G. Wilkins, MD, MSfirstname.lastname@example.org|
|Contact: Jennifer B. Hamill, MPHemail@example.com|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095-6960|
|Contact: Andrew Da Lio, M.D. 310-206-7521 firstname.lastname@example.org|
|Contact: Maria Etchepare, N.P. 310-825-5510 email@example.com|
|Principal Investigator: Andrew Da Lio, M.D.|
|United States, District of Columbia|
|Georgetown University Hospital||Recruiting|
|Washington, D.C., District of Columbia, United States, 20007|
|Contact: Scott Spear, M.D. 202-444-8612 firstname.lastname@example.org|
|Contact: Veronica Rodriguez 202-444-7060 Veronica.M.Rodriguez@gunet.georgetown.edu|
|Principal Investigator: Scott Spear, M.D.|
|United States, Georgia|
|Georgia Institute for Plastic Surgery||Recruiting|
|Savannah, Georgia, United States, 31405|
|Contact: Richard Greco, M.D. 912-355-8000 email@example.com|
|Contact: Teri Goolsby, RN (912) 355-8000 Terig@mycosmeticsurgeon.md|
|Principal Investigator: Richard Greco, M.D.|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611-2923|
|Contact: John Kim, M.D. 312-266-6240 firstname.lastname@example.org|
|Contact: Neil Fine, M.D. 312-266-6240 nfinemd.@gmail.com|
|Principal Investigator: John Kim, M.D.|
|Sub-Investigator: Neil Fine, M.D.|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Yoon Chun, MD 617-983-4600 YCHUN@PARTNERS.ORG|
|Contact: Gretchen Guldbrandsen 617-983-4600 GGULDBRANDSEN@PARTNERS.ORG|
|Principal Investigator: Yoon Chun, M.D.|
|United States, Michigan|
|University of Michigan Medical Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Edwin G. Wilkins, M.D., M.S. 734-936-6680 email@example.com|
|Contact: Brigid Rowell, M.A. 734-998-5622 firstname.lastname@example.org|
|Principal Investigator: Edwin G. Wilkins, MD, MS|
|St. Joseph's Mercy Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48197|
|Contact: Daniel Sherick, M.D. 734-712-2323 email@example.com|
|Contact: Brigid Rowell, M.S. 734-998-5622 firstname.lastname@example.org|
|Principal Investigator: Daniel G. Sherick, M.D.|
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center||Recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Dale C. Vidal, M.D. 603-650-5628 Dale.email@example.com|
|Principal Investigator: Dale C. Vidal, M.D.|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Andrea L Pusic, MD MHSA 212-639-5085 firstname.lastname@example.org|
|Contact: Meghan Lee, B.A. 646-227-2380 LeeM5@mskcc.org|
|Principal Investigator: Andrea L. Pusic, MD, MHSA|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43212-3154|
|Contact: Gayle Gordillo, M.D. 614-239-8566 email@example.com|
|Contact: Sofia Durani 614-366-1333 Sofia.Durrani@osumc.edu|
|Principal Investigator: Gayle Gordillo, M.D.|
|Sub-Investigator: James Boehmler, M.D.|
|United States, Texas|
|M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Steve Kronowitz, M.D. 713-794-1247 firstname.lastname@example.org|
|Principal Investigator: Steve Kronowitz, M.D.|
|Canada, British Columbia|
|Providence Health Care - University of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Nancy Van Laeken, M.D. 604-669-1633 email@example.com|
|Contact: Julianna Kowal 604-682-2344 ext 62883 JKowal@providencehealth.bc.ca|
|Principal Investigator: Nancy Van Laeken, M.D.|
|University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Contact: Ed Buchel, M.D. 204-787-1485 firstname.lastname@example.org|
|Contact: Kimberly R Dalke, M.S. 204-787-3915 email@example.com|
|Principal Investigator: Ed Buchel, M.D.|
|Principal Investigator:||Edwin G Wilkins, MD, MS||University of Michigan|
|Principal Investigator:||Andrea L. Pusic, MD, MHSA||Memorial Sloan-Kettering Cancer Center|