MDACC Study Summary 2007-0828 (Archived)

Study Summary
No. 2007-0828:.......Breast; Cancer Control......Elisabeth Beahm......Plastic Surgery

Study Summary Title



Study Summary Number:	2007-0828

Study Title:	The International Breast Reconstruction Outcomes Consortium (IBROC) Pilot Study

Physician

New Patient Referral



Name:	Elisabeth Beahm	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Plastic Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1247 Contact us about clinical trials

General Information



Disease Group:	Breast Cancer Control	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	2 times; once pre-operatively and once post-operatively (3 months)

Treatment Agents:	None	Home Care:	Usual post-operative standard of care. There are no additional care requirements for the purpose of this study.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	This goal of this study is learn how women respond to a mastectomy and reconstructive surgery.

Study Objectives / Outcomes

Specific aims of the proposed IBROC Pilot 1 project are as follows:

1.) To establish an international consortium of institutions and the prototype of a central, on-line patient registry/database for tracking long-term outcomes in breast reconstruction.
2.) To establish a standard panel of instruments for assessing the following outcomes of breast reconstruction: complication rates, patient satisfaction; health-related quality of life, including psychosocial and physical functioning.
3.) To pilot test the survey instruments, on-line database, and other data-gathering infrastructure required for a long-term outcome study of common breast reconstruction procedures, including tissue expanders/implants; latissimus dorsi (LD) flaps; pedicle transverse rectus abdominis musculocutaneous (PTRAM) flaps with and without surgical delays; deep inferior epigastric perforator (DIEP) flaps; and gluteal artery perforator (GAP) flaps.

Study Status Information



Study Activation / Registration Date:	12/17/2007

IRB Review and Approval Date:	12/17/2007

Study Type:	Behavioral

Recruitment Status:	Terminated

Projected Accrual:	110

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Undergoing first time immediate or delayed reconstruction with expander/implant or flap techniques following mastectomy for breast cancer treatment.

2) Female patients who present themselves for breast reconstruction at any of the eleven participating centers during the study and who meet the clinical criteria.

Exclusion Criteria:

1) Women electing reconstruction following complications of breast augmentation, mastopexy, or breast reduction.

2) Women requiring revision of a previous reconstruction procedure.

3) Patients with any of the following conditions: Age greater than 70 years; Insulin-dependent diabetes (IDDM), congestive heart failure (CHF), symptomatic atherosclerotic coronary artery disease (ASCAD) with or without a history of myocardial infarction (heart attack), chronic obstructive pulmonary disease (COPD), and/or morbid obesity (BMI >/= 40).

4) Patients who choose not to undergo breast reconstruction.

5) Women receiving mastectomy for cancer prophylaxis, without a history of breast cancer.

Links

Registration Number: Not Applicable Clinical Trial