NCT01723423

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,436

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 13, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

February 29, 2012

Last Update Submit

July 12, 2017

Conditions

Breast Cancer

Keywords

breast cancerevidence based medicinereconstructionmastectomyoutcomesquality of life

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in health-related quality of life.

    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 Outcomes (2)

  • The effects of race and ethnicity on 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.

    2 years postoperatively

Study Arms (8)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Georgia Institute for Plastic Surgery

Savannah, Georgia, 31405, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611-2923, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph's Mercy Health System

Ann Arbor, Michigan, 48197, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43212-3154, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Providence Health Care - University of British Columbia

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (5)

  • Wilkins EG, Cederna PS, Lowery JC, Davis JA, Kim HM, Roth RS, Goldfarb S, Izenberg PH, Houin HP, Shaheen KW. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2000 Oct;106(5):1014-25; discussion 1026-7. doi: 10.1097/00006534-200010000-00010.

    PMID: 11039373BACKGROUND

  • Alderman AK, Kuhn LE, Lowery JC, Wilkins EG. Does patient satisfaction with breast reconstruction change over time? Two-year results of the Michigan Breast Reconstruction Outcomes Study. J Am Coll Surg. 2007 Jan;204(1):7-12. doi: 10.1016/j.jamcollsurg.2006.09.022. Epub 2006 Nov 16.

    PMID: 17189107BACKGROUND

  • Alderman AK, Wilkins EG, Kim HM, Lowery JC. Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2002 Jun;109(7):2265-74. doi: 10.1097/00006534-200206000-00015.

    PMID: 12045548BACKGROUND

  • Roth RS, Lowery JC, Davis J, Wilkins EG. Persistent pain following postmastectomy breast reconstruction: long-term effects of type and timing of surgery. Ann Plast Surg. 2007 Apr;58(4):371-6. doi: 10.1097/01.sap.0000239810.38137.84.

    PMID: 17413877BACKGROUND

  • Hu ES, Pusic AL, Waljee JF, Kuhn L, Hawley ST, Wilkins E, Alderman AK. Patient-reported aesthetic satisfaction with breast reconstruction during the long-term survivorship Period. Plast Reconstr Surg. 2009 Jul;124(1):1-8. doi: 10.1097/PRS.0b013e3181ab10b2.

    PMID: 19568038BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Edwin G Wilkins, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Andrea L. Pusic, MD, MHSA

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

February 29, 2012

First Posted

November 7, 2012

Study Start

August 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 13, 2017

Record last verified: 2017-03

Locations

US(9)CA(2)