Mastectomy Reconstruction Outcomes Consortium (MROC) Study

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01723423
First received: February 29, 2012
Last updated: August 3, 2015
Last verified: August 2015
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mastectomy Reconstruction Outcomes Consortium (MROC) Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 7170
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)
Groups/Cohorts
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 (S-GAP) breast reconstruction.
I-GAP
Patients inferior gluteal artery perforator (I-GAP) breast reconstruction.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing first-time breast reconstruction at one of 13 consortium sites.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723423

Locations
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
St. Joseph's Mercy Health System
Ann Arbor, Michigan, United States, 48197
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
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
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
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
Investigators
Principal Investigator: Edwin G Wilkins, MD, MS University of Michigan
Principal Investigator: Andrea L. Pusic, MD, MHSA Memorial Sloan Kettering Cancer Center
  More Information

Publications:
Responsible Party: Edwin G. Wilkins, Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT01723423     History of Changes
Other Study ID Numbers: 10-PAF07150
Study First Received: February 29, 2012
Last Updated: August 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
breast cancer
evidence based medicine
reconstruction
mastectomy
outcomes
quality of life

ClinicalTrials.gov processed this record on August 26, 2015