Mastectomy Reconstruction Outcomes Consortium (MROC) Study (MROC)

July 12, 2017 updated by: Edwin G. Wilkins, University of Michigan
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 Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

4436

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Providence Health Care - University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba
  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Georgia Institute for Plastic Surgery
    • Illinois
      • Chicago, Illinois, United States, 60611-2923
        • Northwestern Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Ann Arbor, Michigan, United States, 48197
        • St. Joseph's Mercy Health System
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43212-3154
        • Ohio State University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing first-time breast reconstruction at one of 11 consortium sites.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
2 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

University of Manitoba
M.D. Anderson Cancer Center
Memorial Sloan Kettering Cancer Center
Georgetown University
Brigham and Women's Hospital
Ohio State University
Providence Health & Services
Northwestern Memorial Hospital
Saint Joseph Mercy Health System
Georgia Institute for Plastic Surgery

Investigators

  • Principal Investigator: Edwin G Wilkins, MD, MS, University of Michigan
  • Principal Investigator: Andrea L. Pusic, MD, MHSA, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

November 5, 2012

First Posted (ESTIMATE)

November 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-PAF07150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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