Downstaging Breast Cancer Globally

Breast cancer is the most frequent and fatal malignancy in women, worldwide. In 2020 alone, 2.3 million women were newly diagnosed, and 685,000 died from breast cancer that estimated at 740,000 in 2024. Moreover, 7.8 million women live with breast cancer, making it the most prevalent of all cancers according to the world health organization's (WHO) Global Cancer Observatory (GCO). Breast cancer also exceeds all cancers in lost disability-adjusted life years(DALYs) with nearly20 million years of health lost. African women and African American women are 40% more likely to die from breast cancer than women of all other races. Moreover, among young women 25 to 39 breast cancer morbidity and mortality is increasing globally and is projected to outpace all others. (WHO current estimate chart below) 

Young women 25-39 projected increase in breast cancer incidence WHO

While the unmet need appears daunting, evidence confirms that physical (clinical/CBE) breast exam for women with elevated risk in low and medium resource countries (LMICs) can markedly downstage the disease and significantly extend their lives and health. To be effective however, essential skills are required to avoid false alarms (false positive reports) and to reliably confirm the presence of self-reported tumors. Early detection of breast cancer whether by viewing images on mammograms or by thorough palpation of the breast tissues requires practice and skill. The error rate of both are similar and decreases sharply with training.  

We, a team of university scientists, nurses and physicians studied the performance and accuracy of clinical breast exams. We conducted the trials required to determine the competencies required for accurate performance without elevating false positive alarms. This proposal is about a technology that can provide the essential breast exam skills to every hand that examines women for breast cancer. 

The MammaCare team of scientists and clinicians developed an effective, low cost and safe means for early detection of breast cancer and are trying to make it available where it is most needed for women and their providers who have no other means of early detection of breast cancer.  We built and tested the first technology that enables healthcare workers anywhere to perform accurate and effective breast exams. The breast exam trainer measures, corrects and documents the ability of local providers to detect small suspicious breast tumors without increasing false positives. 

With support from the National Science Foundation (NSF) and pro-bono assistance from colleagues at pioneering cloud developers, Capgemini and Qlik, we were able to create a training network, a breast exam network that connects breast exam training technology to local healthcare providers with only a minimal internet connection (=>3Mbps). The training network remotely measures and corrects breast examination skills in real time allowing health providers everywhere to acquire the competencies needed to perform the exam accurately and thoroughly. 

The self-administered program is performed and practiced  using a unique portable palpation measurement device connected to any laptop with a standard USBc cable. It guides and measures exam performance while testing and reporting the users essential exam skills and thoroughness. Feedback automatically corrects performance errors in real time and transmits  the completed data to instructors using minimal internet connectivity. 

Plainly said, the MammaCare Breast Exam Training Network and CBE Trainer is the first, evidence based, scalable training technology that can teach healthcare workers  everywhere to perform competent CBEs while documenting their performance, everywhere.

In HICs a mammography infrastructure is well supported and widely available for screening. Nevertheless, CBEs performed by trained hands of practitioners are an inexpensive and effective method for early breast cancer detection. Unfortunately, there has been little support for clinical breast exam training although  evidence supports its wide use.  

The need for such a training system to advance health in LMICs is clearly observed in this landmark report in The Lancet:  

"Institutions in high-income countries (HICs) are the main funders and generators of academic knowledge on health systems in low-income and middle-income countries (LMICs), and much too often this knowledge reflects their priorities rather than the needs of health systems in LMICs. 1,  2 " 

The urgent need for accessible, measurable breast exam training is repeated in numerous seminal studies and reports. The technology presented here meets that need and can readily be deployed within any village or city with minimal internet requirements. The system was successfully deployed and tested African and Haitian midwives who work in remote areas. The data from these trials and others from a CDC early detection program is available for review. 

This solution serves the midwives, nurses, healthcare workers and clinicians in LMICs who perform or need to perform skilled breast exams but have little or no training or method to learn the most accurate and effective techniques. Most importantly, it serves the underserved women who are at risk of late detected and undetected breast cancer but have no local or regional provider trained in the skill. The target population includes every hand that examines a woman for breast cancer for every woman who is at risk. 

Because the earliest sign of breast cancer is a lump most often found by a woman herself and few providers are prepared to perform skilled breast exams, detection and treatment are often delayed until the later more advanced debilitating and deadly stages of the disease. This is true in both HICs and LMICs although the health and medical infrastructure in HICs supports detection benefits that are not available to most women elsewhere. 

Chemotherapy is now highly effective in the early stages of breast cancer ( 1 to 3) and has become more widely available for women and providers in LMICs making early detection the primary course of action that can meaningfully improve the functioning and outlook for millions of women in LMICs.  The distribution of the training technology and connection to the  network has few requirements other than a laptop or computer, a Google browser and a connection to the internet.     

Regarding proximity, we are somewhat different from other programs. Our work developing a universal breast exam training technology reaches across countries to train the hands of healthcare workers to perform accurate, skilled breast exams. The training protocol is a standard for early breast cancer detection and we have finally been able to make it available worldwide using any laptop anywhere. It trains and documents the skills required for earliest detection of breast cancer and it was necessary to provide this first hands-on training via any minimal internet connection.  The background note below may help to introduce the reader in how the work evolved    

The team was selected by the  National Cancer Institute to initially investigate the effectiveness of physical examination of the breast. With their support we conducted the first body of (now legacy) research and it represents most of the work identifying the variables for effective breast examination. One collection of reports may be reviewed here (Google Scholar 1)  and a body of scientific or clinical reports  on the application of the technology is here (Google Scholar 2) a well as important related reports summarized here

Our work focuses on training clinical hands to for early detection of breast cancer. Currently we are training the hands of nurses, midwives physicians and local healthcare workers in Ghana, Jordan, a VA Womens Health Program  and a statewide early detection program.

The data below represent and document every palpation and detection of a replicated breast cancers while mapping the location of the tumors detected and undetected. Progress in making correct detections and reducing false detections is automatically analyzed, digitally recorded and retained. Incoming data continuously increments in the the system which is plainly ready for deployment where it is most needed. 

e.g. Preliminary analytics for clinical cohort 

45,000 Breast exams performed

120,000+ true positive detections 

Most users require several attempts to complete a module and the system analyzes the results from each of attempt to complete it, requesting that it be repeated to achieve built in performance goals. Evidence of progress, examination accuracy, is generated over the sessions as skills are acquired. These data are a summary of user progress while passing one or more training modules. It presents the number of actual true and false detections as well as the breast area missed and palpated reporting whether light medium and deep pressure was used in each location of the exam. 

Our technology early detection training programs have been acquired by more than 22 colleges of nursing and medicine, 17 US breast centers, and three state public health systems and 5 public and private health organizations in 5 countries. These data do not include our clinical breast exam certification programs. About 700 clinical breast examiners have been trained and certified within the preceding  7 years    

We are clinicians and scientists at the stage and are inexpert at marketing and distribution although it appears the technology is ready.  Solve appears to have deep understanding and sincere  interest in game changing advances and may be able to provide appropriate connections in this regard. The vast range of ideas and  support for change in Solve's one- of-a-kind platform is intriguing so it makes sense to take the next step. Many of the ideas and proposals herein appear willing to break the rules without obedience to protocols that have declined in effectiveness or actually were never were except to sustain themselves. So Solve is exciting to  our lab which is run by young  engineers and scientists that live for useful innovation. Simply said,  Solve feels like home. By the way, I am only the chair because the younger ubergeeks who direct and run our lab depend on me in part to find funds for their adventures and misadventures as well as for guidance or advice  from an older scientist who has made all the errors and corrected most.   

The majority of asymptomatic women in HICs, estimated at more than 60%, are screened annually or now biannually. The resulting x-rays mammograms are interpreted by a radiologist. The  screening  procedure  is no longer annual due in part to the x-ray dosage which was increased to provide greater image clarity and concerns over false positive detections. The costs and technical infrastructure required for mammography are unfeasible in LMICs. Evidence indicates that trained clinical hands can provide early detection for millions of women who are at elevated risk in LMICs.    

As mentioned earlier, the earliest sign of breast cancer is a lump, most often noticed first by the woman herself. The problem was that clinically confirming the presence of the suspicious lump required skills that were poorly understood because there was no way to externally measure or visualize the touch sensations experienced during a breast exam. Unlike visible images that can be shared, touch sensations are private sensory experiences available only to the examining person.  

So we invented an electronic method to precisely measure and display the sensations produced when examining biological tissues. It was designed to generate a three dimensional digital map of the (tactile) sensations experienced in fingers when palpating normally fibrous (lumpy) breast tissues and when feeling small hidden breast cancers, although it could be adapted for any clinical examination that relies on touch.  

The data that emerged from trials with practicing clinicians allowed us to standardize and calibrate the skills required for accurate performance of physical examination of the breast. The next step was to build and test a  hands-on technology that could be deployed anywhere to measure  train and calibrate the hands of local heath care workers and document the results. 

The urgent need for a method to train the hands of local providers in LMICs is well documented by clinicians and  epidemiologists. We believe that this opens a first opportunity to expand and improve the practice of clinical examination of the breast in LMICs. As the first method capable of  validating the accuracy of physical examination, the underlying technology development and calibration of touch also presents a potentially valuable impact on medical training worldwide

Breast cancer in LMICs is endemic and disproportionately affects young women of child bearing and child raising age, devastating not only the families but the communities and villages in which they and their children live. 

Yet breast cancer is curable when caught at its earliest stages and can be treated as a manageable chronic disease during which women maintain their roles and routines, whereas the later stages of the disease and its sequelae are debilitating and deadly. Marginalized communities do not have access to advanced imaging technology nor is it required to  create a community of women and caregivers who are enabled to perform exams proficiently. The training technology provides skills needed for performing competent breast exams and will positively impact the hands and fate of women as well in remote marginalized communities as in more advanced ones.

Breast cancer in LMICs is endemic and disproportionately affects young women of child bearing and child raising age. Wealthy countries have devoted resources for early detection of the disease although the solutions produced  in LMICs are not available to women elsewhere. Nevertheless, there is an answer. 

Breast cancer at its earliest stages can be treated as a manageable chronic disease during which women maintain their roles and routines, whereas the later stages of the disease and its sequelae are debilitating. Marginalized communities do not have access to advanced imaging technology nor do they need it to effectively create a community of women and caregivers who are enabled to perform exams proficiently. The training technology provides skills needed for performing competent breast exams and will positively impact the hands and fate of women as well in remote marginalized communities as in more advanced ones.

The earliest sign of breast cancer is a palpable lump in the breast. It found most often by women themselves   who are then examined by health workers who lack essential examination skills. We developed and tested the first technology that trains, tests and validates acquisition of essential exam skills anywhere there is a connection to the internet. This is the first inexpensive, ready to deploy early detection technology that can improve survival from endemic breast cancer globally.  The cost, complexity and medical infrastructure required for mammography and imaging technologies make it unavailable for the vast majority low and medium income countries  (LMIC).   

Incoming data from ongoing training onthe breast exam training system  is recorded on our cloud instance in digital form. Every palpation on every training model in every location is identified and retained. Each correct detection and false detection are also digitally recorded and retained. Incoming data increments in the the system continuously, for which the latest observed events from several thousand users were 45,000 Breast exams performed, 120,000+ true positive detections of breast cancer replicas.

During training the number of true and false positive detections change as the system analyzed data from each attempt to complete a training module and requires that it be repeated. Thus evidence of progress,  examination accuracy, is generated over the sessions (skill acquisition). So the resulting data is a time capsule from thousands of palpations that completed one or more modules but it accurately reflects the number of reported detections  

As of this writing I do not have the cumulative reports of false positive detections across trials and cohorts . Nevertheless, there is a well established orderly decline in false detections during training as displayed below and earlier from a clinical student cohort.  

The original training technology was initiated by the National Cancer Institute and advanced thereafter with the support of the National Science Foundation (NSF) and colleagues worldwide all of whom recognize the need for earliest possible detection of breast cancer.  There is no other technology to our knowledge that can train the  hands of healthcare workers to develop and evaluate and improve their breast exam skills. Based on a traditional physical (clinical) examination of the breast we advance the art by providing the first measurement of the technique and applied hands-on computer guided technology that improved the practice, correcting errors and assuring thorough examination of all breast tissues. The result is real time, online digital profile of the  exam that quantifies its performance and validates its accuracy. The hands of practitioners are  connected via Google browser to a  cloud-based learning management system ( LMS ) that interacts with and guides the procedure. The hardware software components of the training system are proprietary.

Data generated  provided by the technology has been included elsewhere. I assembled a few of the references to trials of Mammacare training results below: 

Training in clinical breast examination as part of a general surgery core curriculum S Aliabadi‐Wahle, M Ebersole, EU Choe… - … of Cancer Education, 

A focused breast skills workshop improves the clinical skills of medical students ) GT Ault, M Sullivan, J Chalabian, KA Skinner - Journal of Surgical education found in the ambulatory setting, we inaugurated a focused breast skills workshop during the required surgical …  breast models (Mammacare) and document their …

Cite Cited by 24 Related articles All 7 versions

A description of breast models used to teach clinical skills

C McCabe, C Ly, B Gregg, OS Anderson - Breastfeeding Medicine, 2022 - liebertpub.com … training of clinical skills in breastfeeding management, the general breast exam, and surgery…  

Results of an office‐based training program in clinical breast examination for primary care physicians

TA Benincasa, ES King, BK Rimer… - … of Cancer Education, - Taylor & Francis … In one study, 80 physicians from primary care, obstetrics, gynecology,and surgery accurately Comprehensive MammaCare training uses both patient surrogates and silicone models as …

Performance and reporting of clinical breast examination: a review of the literature

S McDonald, D Saslow… - CA: a cancer journal for …, 2004 - Wiley Online Library … In this study, the nurses were trained in CBE by the surgeons… Similarly, a physician education intervention that consisted of … the MammaCare method before training; after training

[PDF] The effectiveness of postgraduate education on the clinical breast examination skills of primary care physicians

RL Smith, NA Hanchak, D Leibreid - Am J. Man. Care,- ajmc.s3.amazonaws.com … , office-based, clinical breast examination training program … breast examination, based on
the MammaCare" method; and (4) … increase in referrals to surgeons and gynecologists was the …

MammaCare: a case history in behavioural medicine

HS Pennypacker, MM Iwata - Behaviour Analysis in Theory and …, 2013 - taylorfrancis.com …l … training
in physical examination of the breast that characterises contemporary medical education. In …

Cite Cited by 22 Related articles All 2 versions 

Structured clinical breast examination (CBE) training results in objective improvement in CBE skills

JT Vetto, JK Petty, N Dunn, NC Prouser… - … of Cancer Education, 2002 - Taylor & Francis … could on a silicone MammaCare breast model that contained … research shows that training
with MammaCare silicone breast … in clinical breast examination as a part of a general surgery …

Cancer skills laboratories for medical students: a promising approach for cancer education

AC Geller, MN Prout, T Sun, R Krane… - … of Cancer Education,  - Taylor & Francis … The students are first asked to examine Mammacare models that have been covered with …
training, students are again asked to record the number of lumps using the same Mammacare …

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Full time 4

Part time 3

Contractors 2

Research Assistants/interns 2 or more  (UF 9 Month Schedule) 

University and federal laboratory studies of early breast cancer detection began in 1975 and continued, without interruption, to the present. By1985  privately raised funds and grants supported further development of the technology. The work continued at MammaCare owned facilities proximal to the University and continues to the present supported by clinical breast examination certification fees and sales of breast examination training software, hardware and technology.   

MammaCare Foundation has few employees and all but one have participated in the project without break for a decade or more.  The entire team is a joyful, open group of technology wizards and public health professionals  all but one of whom have rejected substantial corporate offers in order to participate in work they know is completely dedicated to the goal of sparing women from late stage breast cancer. Our interns and research assistants have represented every race and culture and most have taken positions in medicine and science that advance women's health. 

There are two recognizable groups of beneficiaries. Health workers in LMICs are the direct beneficiaries of Mammacare technology and training. The women they serve are the ultimate beneficiaries. 

The rationale for our professional customers is compelling and apparent, increased skill and ability to detect or confirm the detection of breast cancer at earliest or earlier stages.

We engage with users of the technology where allowed by local standards of disclosure to determine the impact of the services provided on the health and functioning of patients over time,  measured in quality of life years and  years of post treatment survival,

For more than 4 decades Mammacare has devoted all of its fees  and sales revenues, grant support funds, and any "surplus" funds to its widely published goal of: "training  every hand that examines a woman for breast cancer, including her own." This is and will remain the sole goal of the  MammaCare Foundation's training, tools and technology. 

The Foundation's business model is based on fees and sales generated by its breast exam training technologies as well as donations and grants. The income from these sources has provided about half of the operating revenue for most of the last 15 years with supplemental support from grants and donations.

We have of late expanded our relationship with foreign distributors due to increased interest in the technology. The new breast exam training network (LMS) has stimulated the interest of distributors because it provides a means for them to gain both product and fee revenues. While distributors are a key to grow customer acquisition, we will maintain direct sales to academic customers wherever desired by the institutions who use and seek to use our technology.     

Our operational strategy will necessarily change as LMICs sign on for training of their health workers. The LMS is designed within the Google to manage incoming training data for an unlimited number of users of worldwide users although each requires staff attention during set up. We are prepared to create a management team to work directly with user organizations and we are open and will actively pursue external management of this function.

Because the Foundation is  situated proximately to one of the largest US universities and because we  have close relationships with technical departments and faculties, we are in an excellent position readily find the talent that can advance the global goals. This is a special case because the student body at UF is comprised students and graduate students from nearly every global culture and region, from which we have already benefitted.         

The Foundations social and enterprise programs are nearly identical. They both serve our stated mission for which the business was created. All business activities are based on the social impact in region served because both depend on voluntary participation of those who acquire the training and the women use and depend on it.