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. 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 as an important variable. 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 five commonly used options for breast reconstruction: expander/implant, latissimus dorsi/implant, pedicle transverse rectus abdominis musculocutaneous (TRAM), free TRAM, and deep inferior epigastric perforator techniques. Outcomes assessed will include complications, postoperative pain, psychosocial well-being, physical functioning, patient satisfaction and costs. The project will also evaluate the effects of race and ethnicity on reconstruction outcomes. Nine leading centers in the United States will participate. Together, these institutions perform over 2700 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.

Public Health Relevance

The Mastectomy Reconstruction Outcomes Consortium (MROC) Study will bring together nine leading centers in the United States to compare the outcomes of common techniques for breast reconstruction. Implant and natural tissue techniques will be compared using a variety of measures, including complication rates and costs. Most importantly, these options will be assessed using data from patient surveys that ask about post-operative pain, quality of life, body image, sexuality, physical functioning, and patient satisfaction, the outcomes that matter most to women. To track the long-term results of these operations, this five year study will follow patients for two years after their reconstructions. The effects of race and ethnicity on breast reconstruction outcomes will also be studied. Findings from the MROC study will assist patients, surgeons, payers and policy makers in identifying the most effective surgical options for women seeking reconstruction after mastectomy. Study results will also help design reconstruction services which better meet the needs and preferences of diverse patient populations.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA152192-02
Application #
8309951
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Castro, Kathleen M
Project Start
2011-08-01
Project End
2016-05-31
Budget Start
2012-06-01
Budget End
2013-05-31
Support Year
2
Fiscal Year
2012
Total Cost
$959,795
Indirect Cost
$106,479
Name
University of Michigan Ann Arbor
Department
Surgery
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Clemens, Mark W (2018) Direct-to-Implant versus Two-Stage Tissue Expander/Implant Reconstruction: 2-Year Risks and Patient-Reported Outcomes from a Prospective, Multicenter Study: Correction. Plast Reconstr Surg 141:532
Roth, Randy S; Qi, Ji; Hamill, Jennifer B et al. (2018) Is chronic postsurgical pain surgery-induced? A study of persistent postoperative pain following breast reconstruction. Breast 37:119-125
Erdmann-Sager, Jessica; Wilkins, Edwin G; Pusic, Andrea L et al. (2018) Complications and Patient-Reported Outcomes after Abdominally Based Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study. Plast Reconstr Surg 141:271-281
Yoon, Alfred P; Qi, Ji; Brown, David L et al. (2018) Outcomes of immediate versus delayed breast reconstruction: Results of a multicenter prospective study. Breast 37:72-79
Wilkins, Edwin G; Hamill, Jennifer B; Kim, Hyungjin M et al. (2018) Complications in Postmastectomy Breast Reconstruction: One-year Outcomes of the Mastectomy Reconstruction Outcomes Consortium (MROC) Study. Ann Surg 267:164-170
Berlin, Nicholas L; Hamill, Jennifer B; Qi, Ji et al. (2018) Nonresponse bias in survey research: lessons from a prospective study of breast reconstruction. J Surg Res 224:112-120
Jagsi, Reshma; Momoh, Adeyiza O; Qi, Ji et al. (2018) Impact of Radiotherapy on Complications and Patient-Reported Outcomes After Breast Reconstruction. J Natl Cancer Inst 110:
Sinha, Indranil; Pusic, Andrea L; Wilkins, Edwin G et al. (2017) Late Surgical-Site Infection in Immediate Implant-Based Breast Reconstruction. Plast Reconstr Surg 139:20-28
Billig, Jessica; Jagsi, Reshma; Qi, Ji et al. (2017) Should Immediate Autologous Breast Reconstruction Be Considered in Women Who Require Postmastectomy Radiation Therapy? A Prospective Analysis of Outcomes. Plast Reconstr Surg 139:1279-1288
McCarthy, Colleen M; Hamill, Jennifer B; Kim, Hyungjin Myra et al. (2017) Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study. Ann Surg Oncol 24:2502-2508

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