Breast CancerMROCNCT01723423
Mastectomy Reconstruction Outcomes Consortium (MROC) Study
An observational study of Breast Cancer, run by University of Michigan at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 4,436 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Aug 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing first-time breast reconstruction at one of 11 consortium sites.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
St. Joseph's Mercy Health System
Ann Arbor, Michigan, 48197
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern Memorial Hospital
Chicago, Illinois, 60611-2923
Ohio State University Medical Center
Columbus, Ohio, 43212-3154
M.D. Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Georgia Institute for Plastic Surgery
Savannah, Georgia, 31405
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Canada2 sites
Providence Health Care - University of British Columbia
Vancouver, British Columbia
University of Manitoba
Winnipeg, Manitoba, R3A 1R9
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, evidence based medicine, reconstruction, mastectomy, outcomes, quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Obtain descriptive statistics on the costs of each of the seven procedure types, to gain a better understanding of the cost differences between procedures.
Measured: 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,436 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, M.D. Anderson Cancer Center, Northwestern Memorial Hospital, Georgetown University, Ohio State University, Trinity Health Michigan, Georgia Institute for Plastic Surgery, Brigham and Women's Hospital, University of Manitoba, Providence Health & Services
- Responsible party
- Principal investigator, Edwin G. Wilkins, University of Michigan
- Investigators
- Edwin G Wilkins, MD, MS, Principal investigator, University of MichiganAndrea L. Pusic, MD, MHSA, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723423
- Sponsor's protocol ID
- 10-PAF07150
- Acronym
- MROC
- Status last verified
- Mar 2017
- First submitted
- 29 Feb 2012
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11039373Alderman 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.
PubMed 17189107Alderman 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.
PubMed 12045548Roth 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.
PubMed 17413877Hu 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.
PubMed 19568038
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastectomy Reconstruction Outcomes Consortium (MROC) Study
- ClinicalTrials.gov ID
- NCT01723423
- Acronym / sponsor ID
- MROC / 10-PAF07150
- Conditions
- Breast Cancer
- Keywords
- breast cancer, evidence based medicine, reconstruction, mastectomy, outcomes, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,436 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, M.D. Anderson Cancer Center, Northwestern Memorial Hospital, Georgetown University, Ohio State University, Trinity Health Michigan, Georgia Institute for Plastic Surgery, Brigham and Women's Hospital, University of Manitoba, Providence Health & Services
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing first-time breast reconstruction at one of 11 consortium sites.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Descriptive statistics on the relative costs of the eight procedure types.
Time frame: 2 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Background: PubMed 11039373Wilkins 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.
- Background: PubMed 17189107Alderman 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.
- Background: PubMed 12045548Alderman 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.
- Background: PubMed 17413877Roth 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.
- Background: PubMed 19568038Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin G Wilkins, MD, MS principal investigator
University of Michigan
Andrea L. Pusic, MD, MHSA principal investigator
Memorial Sloan Kettering Cancer Center
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Michigan at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723423, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.