MDACC Study Summary 2004-0899

Study Summary
No. 2004-0899:.......Breast......Gregory P. Reece......Plastic Surgery

Study Summary Title



Study Summary Number:	2004-0899

Study Title:	Multimodality anthropometric analysis for quantitative assessment of outcomes in breast reconstructive surgery.

Physician

New Patient Referral



Name:	Gregory P. Reece	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	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	We will obtain data at multiple time points including any preoperative visit and following completion of reconstructon. Number of points will vary based on treatment plan, initial time of recruitmnet, and personal goals for reconstructive treatment.

Treatment Agents:	None	Home Care:	This study involves self-report questionnaires, digital photography and physical measurements. There are no therapeutic interventions of any kind therefore, no home care is necessary.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	This study does not require hospitalization.


Description/ Intervention:	The goal of this clinical research study is to evaluate the accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts. Researchers hope to use what is learned to form the basis for the future development of patient decision making aids. Researchers are also interested in learning more about how patients feel about their appearance.

Study Objectives / Outcomes

The first objective of this study is to assess the accuracy of digital image-processing techniques to provide measurements of human breast physical dimensions. The ultimate usefulness of these techniques is to develop quantitative outcome measures of the visual appearance of breast after local treatments for breast cancer. These measures will be used to improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy and form the basis for the future development of patient decision making aids. The second objective is to evaluate the relationship between patient reported body image outcomes and measurement of human breast physical dimensions for patients with breast cancer.

Study Status Information



Study Activation / Registration Date:	05/07/2008

IRB Review and Approval Date:	07/19/2005

Study Type:	Observational

Recruitment Status:	Open

Projected Accrual:	300

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) Female.

2) Age greater than 21 years old.

3) Candidate who has had or is planning to have breast reconstructive surgery and has at least one breast mound.

4) Willing to participate in the study and able to complete informed consent.

5) Proficient at reading and speaking English.

Exclusion Criteria:

1) Women who have undergone previous bilateral mastecomy without reconstruction.

2) Women who are unable to stand unassisted for 2 minutes.

3) Diagnosis of serious mental illness (e.g., schizophrenia) or cognitive impairment.

Links

Registration Number: NCT00677430
Study Information on Clinical Trials Registry (clinicaltrials.gov)