This Small Business Innovative Research (SBIR) Phase I Project introduces a novel, tactile training technology that produces skilled clinical breast examinations (CBEs). Clinical breast examination is identified by the US Centers for Disease Control and Prevention (CDC) as one of only two primary breast cancer screening modalities, yet nurses report having a lack of knowledge, skill and confidence in their CBE skills. The project?s computer assisted CBE simulator combines tactually accurate breast simulations with an intelligent, skill-based tactile training platform and online distance learning technology. The program rapidly and significantly increases breast examination skills through machine guided manual practice on the tactually accurate breast models that contain small, hidden simulated lesions. It quantifies performance levels and initiates remedial practice until criterion standards of performance are achieved. The result of this project would provide a modern, easily reproducible technology to rapidly expand the corps of skilled nurses who can perform quality-standard breast examinations. The specific aim of Phase l is to demonstrate the rapid acquisition of verifiable CBE knowledge and skill among nursing students and practitioners.

The broad impact of this project is to modernize our antique but critical examination practices to enable nurses to accurately and confidently perform clinical breast examinations. The result could measurably improve U.S. breast cancer screening, a major benefit for women. The proposed technology has great commercial potential because no mass training alternative exists and it could be rapidly expanded to improve breast cancer screening in the U.S. The need for improved early detection of breast cancer and reduced false positives is widely acknowledged and would represent a dramatic, improvement in current breast cancer screening outcomes. This first phase of the project will lead to improved CBE skills among nursing staff and students. There is ample justification for this technology-based CBE training approach as breast cancer remains the most commonly diagnosed cancer among U.S. women and is the second largest cause of death from cancer. Because early detection remains positively associated with survival, accurate and early breast cancer detection is at the key to reducing mortality from this disease.

Project Report

SBIR Phase I, MammaCare Corporation Project Outcome Report One of the most devastating medical errors affecting millions of women is a breast cancer that can be felt by hand but remains unconfirmed for months or years. Known as missed, palpable breast cancer, the cause is plainly, lack of training and skill. The result is delayed diagnosis and disease that is more extensive, painful, and costly. Poorly performed breast exams also result in unnecessarily high rates of false positive findings, "detecting" disease that is not truly present. Breast cancer remains the most commonly diagnosed cancer among US women and is the second largest cause of death from cancer. Nearly 40,000 women will die from breast cancer this year and over 230,000 new cases will be discovered. Early detection remains the best chance for disease free survival. The most common symptom of breast cancer is a lump in the breast yet few clinicians are taught how to perform a proficient breast examination that can reliably detect a suspicious lump when it is small. MammaCare scientists developed and standardized the training and certification for nurses to perform proficient breast exams. This training is taught by expert instructors who teach practitioners how to reliably detect small, suspicious breast lumps, about the size of a pea. However, this training is costly and time consuming. It cannot reach the thousands of students and practitioners who perform these exams. In Phase l, we designed and created a new training technology using computers, the Internet and high-fidelity breast models that provide essential breast exam skills. The training is self-administered, inexpensive, and effective. Our colleagues at the Mayo Clinic found that nursing students and nurses were significantly more accurate in detecting breast tumors after the computer-assisted training than they were before receiving it. The potential benefits of this technology for millions of women are reduced medical errors, improved breast cancer screening accuracy, and better health.

Project Start
Project End
Budget Start
2011-01-01
Budget End
2011-12-31
Support Year
Fiscal Year
2010
Total Cost
$148,200
Indirect Cost
Name
Mammacare Corporation
Department
Type
DUNS #
City
Gainesville
State
FL
Country
United States
Zip Code
32601