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Mastectomy Reconstruction Outcomes Consortium (MROC) Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Mastectomy Reconstruction Outcomes Consortium (MROC) Study


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.


Inclusion Criteria:



- Women who present themselves for reconstruction at one of 13 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change from baseline in health-related quality of life.

Outcome Description:

Patient reported outcome measures will include patient satisfaction, post-operative pain, body image, psycho-social functioning, physical functioning, and fatigue.

Outcome Time Frame:

Change from baseline at 1 week, 3 months, 1 year and 2 years post-operatively.

Safety Issue:

No

Principal Investigator

Edwin G Wilkins, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

10-PAF07150

NCT ID:

NCT01723423

Start Date:

August 2011

Completion Date:

July 2016

Related Keywords:

  • Breast Cancer
  • breast cancer
  • evidence based medicine
  • reconstruction
  • mastectomy
  • outcomes
  • quality of life
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Northwestern Memorial HospitalChicago, Illinois  60611
Brigham and Women's HospitalBoston, Massachusetts  02115
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Ohio State University Medical CenterColumbus, Ohio  43210
M.D. Anderson Cancer CenterHouston, Texas  77030
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University of California, Los AngelesLos Angeles, California  
Georgetown University HospitalWashington, District of Columbia  20007
Georgia Institute for Plastic SurgerySavannah, Georgia  31405
St. Joseph's Mercy Health SystemAnn Arbor, Michigan  48197