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Mastectomy Reconstruction Outcomes Consortium (MROC) Study (MROC)

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ClinicalTrials.gov Identifier: NCT01723423
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
M.D. Anderson Cancer Center
Northwestern Memorial Hospital
Georgetown University
Ohio State University
Saint Joseph Mercy Health System
Georgia Institute for Plastic Surgery
Brigham and Women's Hospital
University of Manitoba
Providence Health & Services
Information provided by (Responsible Party):
Edwin G. Wilkins, University of Michigan

February 29, 2012
November 7, 2012
July 13, 2017
August 2011
December 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01723423 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 seven 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.
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Mastectomy Reconstruction Outcomes Consortium (MROC) Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Women undergoing first-time breast reconstruction at one of 11 consortium sites.
Breast Cancer
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  • Expander/Implant
    Patients receiving expander/implant breast reconstruction procedures.
  • Lat Dorsi
    Patients receiving latissimus dorsi breast reconstructions with or without implant.
  • PTRAM
    Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction.
  • FTRAM
    Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.)
  • DIEP
    Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions.
  • SIEA
    Patients receiving superficial inferior epigastric artery (SIEA)breast reconstruction.
  • S-GAP
    Patients receiving superior gluteal artery perforator breast reconstruction.
  • I-GAP
    Patients receiving inferior gluteal artery perforator breast reconstruction.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4436
6300
December 2016
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01723423
10-PAF07150
Yes
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Edwin G. Wilkins, University of Michigan
University of Michigan
  • Memorial Sloan Kettering Cancer Center
  • M.D. Anderson Cancer Center
  • Northwestern Memorial Hospital
  • Georgetown University
  • Ohio State University
  • Saint Joseph Mercy Health System
  • Georgia Institute for Plastic Surgery
  • Brigham and Women's Hospital
  • University of Manitoba
  • Providence Health & Services
Principal Investigator: Edwin G Wilkins, MD, MS University of Michigan
Principal Investigator: Andrea L. Pusic, MD, MHSA Memorial Sloan Kettering Cancer Center
University of Michigan
March 2017