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 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.