A lump or physical change in the breast

physical breast exam and ultrasound

When a woman or her provider feels a lump or sees an unusual change in the breast, the woman is typically referred for a mammogram.  This is the common procedure but not the best one for the patient or the referring agency.  When there is a physical sign, a lump or visible change in the breast, mammograms can delay diagnosis and treatment  as well as miss breast cancer that is present.1

Physical Breast Exam with Targeted Ultrasound Best

Recent evidence from national health care programs finds that a physical exam is essential for early diagnoses.2 The latest evidence comes from Holland. Dr. Linda Appleman’s team investigated what happens when a self-detected symptom, lump (focal breast complaint) is immediately followed up by targeted ultrasound rather than a mammogram.3

From September 2017 to June 2019, 1,961 women in Holland reported feeling a lump and enrolled into Appleman’s study. Each woman received a targeted ultrasound (US) to determine if the lump she felt was a harmless water-filled cyst or a solid tumor that required biopsy. With ultrasound (US) as the primary imaging tool, 81% of women received normal (benign) results, and 10% of women received confirmation of a malignant tumor (US sensitivity, 98.5% [95% CI: 96, 100]; US specificity, 90.8% [95% CI: 89, 92]). DBT was used after an ultrasound reported negative lump finds to validate ultrasound’s accuracy in order to determine if US could be used as a stand-alone breast imaging modality for assessing lump finds from a physical breast exam.

Dr. Appleman concluded that “[ultrasound] was accurate as a stand-alone breast imaging modality in the assessment of focal breast complaints.”

VA Mini Residencies Advance Clinical Breast Exam Skills

The Journal of Women's Health published a landmark report on the 10 year mini-residency training program provided to thousands of VA Primary Care Providers (PCPs). MammaCare provided the hands-on Clinical Breast Exam CBE Simulator-Trainer  for the VA mini-residency program. The PCPs retained and used the performance skills acquired at the mini-residences reporting significantly greater comfort/confidence levels in performing clinical breast exams.

Improving Public Health

The MammaCare CBE Simulator-Trainer was developed and validated with the support of the National Science Foundation and was adopted for clinical training in the Woman Veterans Health Program as well as in CDC's sponsored National Breast and Cervical Early Detection and Prevention Programs (NBCCEDP).  The skill-based technology has begun training advanced clinicial students in U.S. colleges of nursing and medicine to advance clinical breast exam skills. 

Mini-Residencies Improve Care for Women Veterans: A Decade of Re-Educating Veterans HealthAdministration Primary Care Providers

Linda Baier Manwell, MS, Melissa McNeil, MD, MPH, Megan R. Gerber, MD, MPH, Samina Iqbal, MD, Sarina Schrager, MD, MS, Catherine Staropoli, MD, Roger Brown, PhD, Laure Veet, MD, Sally Haskell, MD, MS, Patricia Hayes, PhD, and Molly Carnes, MD, MS

Background: Many primary care providers (PCPs) in the Veterans Health Administration need updated clinical training in women’s health. The objective was to design, implement, and evaluate a training program to increase participants’ comfort with and provision of care to women Veterans, and foster practice changes in women’s health care at their local institutions. 

Methods: The Women’s Health Mini-Residency was developed as a multi-day training program, based on principles of adult learning, wherein knowledge gleaned through didactic presentations was solidified during small-group case study discussions and further enhanced by hands-on training and creation of a facility-specific action plan to improve women Veterans’ care. Pre, post, and 6-month surveys assessed attendees’ comfort with and provision of care to women. The 6-month survey also queried changes in practice, promulgation of program content, and action plan progress 

Results: From 2008 to 2019, 2912 PCPs attended 26 programs. A total of 2423 (83.2%) completed pretraining and 2324 (79.3%) completed post-training surveys. The 6-month survey was sent to the 645 attendees from the first 14 programs; 297 (46.1%) responded. Comparison of pre-post responses indicated significant gains in comfort managing all 19 content areas. Six-month data showed some degradation, but comfort remained significantly improved from baseline. At 6 months, participants also reported increases in providing care to women, including performing more breast and pelvic examinations, dissemination of program content to colleagues, and progress on action plans

Keywords: Veterans health; clinical competence; continuing; curriculum; education; primary health care; women's health.

Breast Cancer Screening Guidelines

While there are wide differences of opinion among prominent organizations about preferred breast cancer screening guidelines, most breast cancer is first detected bythe hands of women or their health care providers. The American College of Obstetricians and Gynecologists (ACOG) notes that self-exams are effective in detecting breast cancer for a majority of women although this finding conflicts with  the United States Preventive Services Task Force (USPSTF), and the American Cancer Society (ACS). These two organizations jointly recommend against teaching women how to perform self-exams of their breast and discourage screening by the hands of nurses and physicians.

In their current "Practice Bulletin” the American College of Obstetricians and Gynecologists states:

“Although breast-self examination is no longer recommended [by USPSTF ], evidence of the frequency of self-detection of breast cancer provides strong rationale for breast self-awareness in the detection of breast cancer. Approximately 50% of cases of breast cancer in women 50 years and older and 71% of cases of breast cancer in women younger than 50 years are detected by women themselves. (40, 41). For example, 43% of the 361 breast cancer survivors who participated in the 2003 National Health Interview Survey reported detecting their cancer themselves (42). Additional evidence of the important role of breast cancer self- detection comes from a study of low-income women who received breast cancer care through California’s Breast and Cervical Cancer Treatment Program. Of the 921 women in the cohort, 64% detected their breast cancer (43)”.

Although well-intentioned, organizations differ in their opinions and the data selected to support them, issuing press releases may be a disservice to women worldwide. More than 500,000 women die each year from breast cancer and there is little disagreement that most women find their own cancer and at a late stage. Discouraging women and their healthcare providers from learning to perform a thorough, skilled breast exam has a global impact that is unlikely to improve the outcomes for the vast majority of women.

Progress in BSE and CBE

Many of the studies that inspired criticism of breast self-examination (BSE) and clinical breast exams (CBE) were conducted before it was known how to perform the exam effectively and before the advent of advanced breast cancer treatment options.  Women and researchers relied on pamphlets and video demonstrations as teaching devices that failed to address the central question of the tactile sense: what does a lump actually feel like?  To improve tactile  breast exam skills, the National Science Foundation supported development and validation of  a hands-on computer- guided training technology that is now in use teaching students in colleges of medicine and nursing as well as obgyn residents and advanced practice nurses. The platform trains hands to perform accurate clinical breast exams and validates acquisition of the requisite skills. The results of training are reported in terms of sensitivity,  specificity and percent of tissue examined as trainees advance through a series of increasingly complex palpation modules.

Annotated bibliography: Physical Examination of the Breast

A significant number of women present with palpable breast cancer even with a normal mammogram within 1 year. Am J. Surg 2010 Dec;200(6):712-7. Haakinson DJ, Stucky CC, Dueck AC, Gray RJ, Wasif N, Apsey HA, Pockaj B. “Patients presenting with palpable masses on SBE or CBE even with a normal mammogram within 1 year tended to have more aggressive tumors… resulting in more aggressive therapy ”

Palpable presentation of breast cancer persists in the era of screening mammography. J Am Coll Surg. 2010 Mar;210(3):314-8. Mathis KL, Hoskin TL, Boughey JC, Crownhart BS, Brandt KR, Vachon CM, Grant CS, Degnim AAC. “Patients with palpable presentation were younger than those with screen-detected cancer (mean age 57 versus 62 years…” abstract  p1

Discovery of breast cancers within 1 year of a normal screening mammogram: how are they found? Ann Fam Med. 2006 Nov-Dec;4(6):512-8. Carney PA, Steiner E, Goodrich ME, Dietrich AJ, Kasales CJ, Weiss JE, MacKenzie, T. “Having a lump and both a personal and a family history of breast cancer was the most common reason why women initiated a health care visit.”

Self-Detection Remains a Key Method of Breast Cancer Detection for U.S. Women. J Womens Health 2011 Jun 15. [Epub ahead of print] Roth MY, Elmore JG, Yi-Frazier JP, Reisch LM, Oster NV, Miglioretti DL. “Most women survivors  (57%) reported a detection method other than mammographic examination.”

Measuring performance in clinical breast examination. Br J Surg. 2010 Aug;97(8):1246-52.  Wishart GC, Warwick J, Pitsinis V, Duffy S, Britton, PD. “performance measures…could help to identify clinicians who have a lower sensitivity for CBE and who may therefore require feedback and further training.”

Tumor Characteristics Associated With Mammographic Detection of Breast Cancer in the Ontario Breast Screening Program.  J Natl Cancer Inst 2011.Jun 22;103(12):942-50. Epub 2011 May 3 Kirsh VA, Chiarelli AM, Edwards SA, O’Malley FP, Shumak RS , Yaffe MJ, Boyd, NF  “…77% of these were true interval cancers, detected clinically in the 1–2 year interval between screening examinations…” p4

Improved Clinical Breast Examination Competencies Via Intelligent Simulator Training, July 7, 2012   Meeting of the German Society for Senologie, Stuttgart Goldstein M.K.*, Mehn M.A.*, Pennypacker H.S.*, Brost B.C.** Petersen W.O.**, Nicometo A.M.**,  MammaCare* and Mayo Clinic** "Two independent trials found that the CBE Simulator produced significant gains in clinical breast examination skills suggesting that this technology may improve the accuracy and quality of breast cancer screening."

Barton, M. B., Harris, R., & Fletcher, S. W. (1999). Does this patient have breast cancer? The screening clinical breast examination: Should it be done? How? Journal of the American Medical Association, 282(13), 1270-1280. " "Our recommendation incorporates practices from the Mammacare method, because its components have been validated in independent investigations of CBE technique"

Artmann, A., Heyne, M., Kiechle, M., & Harbeck, N. (2005, June 20 Suppl.). Breast self-examination training and counseling as motivation strategies for breast awareness and participation in breast cancer screening programs (ASCO Annual Meeting Proceedings, Part 1). Journal of Clinical Oncology, 24(18S), 1027.

Narod, S.A. (2014). Reflections on screening mammography and the early detection of breast cancer. Current Oncology, 21(5), 210-214.

Vaz-Luis, I., et al. (2014). Outcomes by tumor subtype and treatment pattern in women with small, node-negative breast cancer: a multi-institutional study. Journal of Clinical Oncology, 32(20), 2142-2150.

Adams, C. K., Hall, D. C., Pennypacker, H. S., Goldstein, M. K., Hench, L. L., Madden, M. C., Stein, G. H., & Catania, A. C. (1976). Lump detection in simulated human breasts. Perception and Psychophysics, 20, 163-176.

Atkins, E., Solomon, L. J., Worden, J. K., & Foster, R. (1991). Relative effectiveness of methods of breast self-examination. Preventive Medicine, 14(4), 357-367.

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Breast Exams Skills for Women and their Providers

Antique US Government policies continue to resist safe, low-cost exams leaving women and their healthcare providers in a confusing and costly screening fog.  The evidence however, strongly supports personal and clinical breast exams for early detection. 

An influential agency recommendation against teaching women and their healthcare providers how to perform breast self exams  was first published 2002 based on outdated reports and vague training procedures. The advice continues to be repeated by mammographers, medical trade associations and imaging industry executives influencing both federal and state healthcare policies and practices. The plain take-home for more than 600,000 women who die every year from late stage breast cancer is that they would be better off not being taught to correctly perform the exam themselves or by properly trained clinicians while waiting for an image to reveal the presence of breast cancer. 

Naturally, performing the exam without learning basic skills will  increase false positives and miss suspicious tumors. But the standards for learning to perform clinical and personal breast exams are known, free and safe.

For example:

Physicians and scientists at the University of Washington’s Department of Global Health reported recently that most women receiving care at an urban clinic in Peru detected their own breast cancer finding nearly half of the cancers at early stages. Published in the American Medical Association journal JAMA Onclology,  women who received a previous clinical breast exam by the hands of  trained practitioners were the most likely to find their own breast cancer in its earliest stages. These results  support the recent, massive Canadian National Health Service study of 89,000 women reporting that physical (clinical) examination by trained nurses coupled with self-exam instruction detects the same number of breast cancers as do mammograms. This twenty five year study of 89,000 Canadian women was reported in the prestigious British Medical Journal.  

In summary, compelling evidence requires  a change in US policy  for teaching women and for training clinicians how to perform skilled exams. 

 

 

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Breast cancer presentation and diagnostic delays in young women. Cancer. 2014 Jan 1;120(1):20-5. doi: 10.1002/cncr.28287. Nov 11. 2014  Ruddy KJ, Gelber S, Tamimi RM, Schapira L, Come SE, Meyer ME, Winer EP, Partridge AH

Most young women detect their own breast cancers… Palpable presentation of breast cancer persists in the era of screening mammography. J Am Coll Surg. 2010 Mar;210(3):314-8. Mathis KL, Hoskin TL, Boughey JC, Crownhart BS, Brandt KR, Vachon CM, Grant CS, Degnim A Patients with palpable presentation were younger than those with screen-detected cancer (mean age 57 versus 62 years… Self-Detection Remains a Key Method of Breast Cancer Detection for U.S. Women. J Womens Health. 2011Aug; 20(8): 1135-9. Roth MY, Elmore JG, Yi-Frazier JP, Reisch LM, Oster NV, Miglioretti DL Conclusion: Most women survivors (57%) reported a detection method other than mammographic examination. A significant number of women present with palpable breast cancer even with a normal mammogram within 1 year. Am J. Surg 2010 Dec; 200(6): 712-7. Haakinson DJ, Stucky CC, Dueck AC, Gray RJ, Wasif N, Apsey HA, Pockaj B. Results: Patients presenting with palpable masses on SBE or CBE even with a normal mammogram within 1 year tended to have more aggressive tumors… resulting in more aggressive therapy.”  Twenty-five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ. 2014 Feb 11;348:g366. doi: 10.1136/bmj.g366. Miller, A. B., Wall, C., Baines, C. J., Sun, P., To, T., & Narod, S. A. Upon finding that most cancers were palpable at mammography screening visits, Miller et; al. concluded: From this we infer that if there is benefit from a mammography only screening programme, it is derived through cancers detectable by a thorough breast physical examination. Discovery of breast cancers within 1 year of a normal screening mammogram: how are they found? Ann Fam Med. 2006 Nov-Dec; 4(6): 512-8. Carney PA, Steiner E, Goodrich ME, Dietrich AJ, Kasales CJ, Weiss JE, MacKenzie, T.  Having a lump and both a personal and a family history of breast cancer was the most common reason why women initiated a health care visit.  Measuring performance in clinical breast examination. Br J Surg. 2010 Aug;97(8):1246-52. Wishart GC, Warwick J, Pitsinis V, Duffy S, Britton, PD. Performance measures…could help to identify clinicians who have a lower sensitivity for CBE and who may therefore require feedback and further training.  Tumor Characteristics Associated With Mammographic Detection of Breast Cancer in the Ontario Breast Screening Program. J Natl Cancer Inst 2011.Jun 22;103(12):942-50. Epub 2011 May 3 Kirsh VA, Chiarelli AM, Edwards SA, O’Malley FP, Shumak RS, Yaffe MJ, Boyd, NF.  …77% of these were true interval cancers, detected clinically {clinical breast exams} in the 1–2 year interval between screening examinations… Excessive resections in breast-conserving surgery: a retrospective multicentre study. Breast J. 2011 Nov-Dec; 17(6): 602-9. Krekel N, Zonderhuis B, Muller S, Bril H, van Slooten HJ, de Lange de Klerk E, van den Tol P, Meijer S. Of all tumors, 72% (525/726) were palpable, and 28% (201/726) were nonpalpable. The tumor stage was T1 in 492 patients (67.8%) and T2 in 234 patients (32.2%).  Does This Patient Have Breast Cancer? The Screening Clinical Breast Examination: Should It Be Done? How? Journal of the American Medical Association, 1999 Oct, 6: 283(13), 1687-9.  Barton, M.B., Harris, R. & Fletcher, S.W. …MammaCare’s standards for teaching and practicing effective CBE emerged from an extensive series of laboratory studies measuring lump detection and breast examination skills using tactually accurate breast models embedded with small, simulated lesions. How best to teach women breast self-examination. A randomized controlled trial. Annals Intern Med. 1990 May 15;112(10):772-9. Fletcher SW, O’Malley MS, Earp JL, Morgan TM, Lin S, Degnan D. Mammacare instruction resulted in more long-term improved lump detection and examination technique use than did traditional instruction or physician encouragement. Breast self-examination instruction should emphasize lump detection skills.  Improved Clinical Breast Examination Competencies Via Intelligent Simulator Training, July 7, 2012   Meeting of the German Society for Senologie, Stuttgart Goldstein M.K.*, Mehn M.A.*, Pennypacker H.S.*, Brost B.C.** Petersen W.O.**, Nicometo A.M.**,  MammaCare* and Mayo Clinic** Two independent trials found that the CBE Simulator produced significant gains in clinical breast examination skills suggesting that this technology may improve the accuracy and quality of breast cancer screening.

M.K. Goldstein, Ph.D.

Senior Scientist and Director

The MammaCare® Foundation

Lab: (352) 375-0607

markgoldstein@mammacare.org

Supported in part by:

nsf-logo


Does This Patient Have Breast Cancer? The Screening Clinical Breast Examination: Should It Be Done? How? "Our recommendation incorporates practices from the Mammacare method, because its components have been validated in independent investigations of CBE technique" JAMA 283(13), (p. 1276), Barton, M.B., Harris, & Fletcher, S.W.

Why So Much Confusion About Breast Self-Exams?

Women everywhere are confused by the conflicting messages they receive about breast self-examination (BSE). A few large private and public agencies vacillate in their recommendations. The media often add to the confusion by uncritically repeating official recommendations that seem to cast doubt on the value of BSE.

Yet the fact remains that a large proportion of breast cancers are discovered by women themselves.

A nationally respected team of researchers reported that  "Self-Detection Remains a Key Method of Breast Cancer Detection for U.S. Women" (1) 

Most women know at least one other woman who has been treated for breast cancer. In many cases the cancer was first found by the woman herself, either by accident or as a result of deliberate self-examination.

Why, then, is BSE condemned when it accounts for so many cancers found?

Part of the answer to this question lies in the very concept of BSE itself.  We now know that BSE is a highly specific skill that cannot be practiced effectively without proper training.  Many of the studies that inspired criticism of BSE were done before we knew how to teach BSE correctly.  Investigators relied on pamphlets and demonstrations as teaching devices and failed to address the central question: what does a lump actually feel like?  As a result, the quality of the BSE studied was deemed by experts to be not particularly useful.

The unreported good news is that some of the most eloquent critics of BSE have hastened to advise that BSE done correctly could be of considerable value in early detection.  For example, David Thomas, senior author of the widely publicized Shanghai study says,

“It is possible that highly motivated women could be taught to detect cancers that develop between regular screenings, and that the diligent practice of BSE would enhance the benefit of a screening program.” "…there is no reason to discourage women who choose to practice BSE from doing so.  However, it should be emphasized to such women that they must practice BSE regularly and with a high degree of proficiency.”(2)

In the same issue of the Journal of the National Cancer Institute, editor Russell Harris opined,

“The results from the Shanghai trial do not mean, however, that all physical examinations of the breast are ineffective. There is evidence that excellent physical examination practice, whether CBE or BSE, may indeed be effective.  Not only is there case–control evidence that excellent BSE may reduce mortality, there is also randomized, controlled trial evidence that excellent CBE done by trained nurse-examiners may be as effective as mammography in reducing breast cancer mortality.” (3)

Nancy Baxter of the Canadian Task Force on Preventive Health Care writes, 

“Any woman who wishes to practise BSE and who requests instructions should be counseled regarding the risks and benefits, and the health care professional should ensure that BSE instruction is thorough and that the woman is performing BSE in a proficient manner.”(4)

So, what constitutes effective instruction in BSE?

There are two components:

  1. Fingers must be taught what to feel for, what a suspicious lump might feel like. This can only be accomplished by palpating a tactually accurate breast model, not by watching a video or reading a pamphlet.
  2. The educated fingers must be brought into contact with all of the breast tissue where a tumor might reside.

The only method presently available that contains both of these critical components is known as MammaCare.

The medical research team that developed MammaCare with the support of the National Cancer Institute wanted it to be available to every woman in an easy-to-use and affordable home kit (MammaCare Personal Learning System).  A noted team of medical scientists examined MammaCare and concluded:

 “Mammacare instruction resulted in more long-term improved lump detection and examination technique use than did traditional instruction or physician encouragement. Breast self-examination instruction should emphasize lump detection skills."

With practice, every woman can become adept at the skill of breast self-examination. An additional benefit, as Dr. Harris says, is that “women may also feel empowered and more in control with this knowledge.”(2)

References

  1. Self-Detection Remains a Key Method of Breast Cancer Detection for U.S. Women. J Womens Health. 2011 Aug; 20(8): 1135-9. Roth MY, Elmore JG, Yi-Frazier JP, Reisch LM, Oster NV, Miglioretti DL.
  2. David B. Thomas, Dao Li Gao, Roberta M. Ray, Wen Wan Wang, Charlene J. Allison, Fan Liang Chen, Peggy Porter, Yong Wei Hu, Guan Lin Zhao, Lei Da Pan, Wenjin Li, Chunyuan Wu, Zakia Coriaty, Ilonka Evans, Ming Gang Lin, Helge Stalsberg, Steven G. Self.  Randomized Trial of Breast Self-Examination in Shanghai: Final Results. Journal of the National Cancer Institute, Vol. 94, No. 19, 1445-1457, October 2, 2002.
  3. Russell Harris and Linda S. Kinsinger.  Routinely Teaching Breast Self-Examination is Dead.What Does This Mean? Journal of the National Cancer Institute, Vol. 94, No. 19, 1420, October 2, 2002.
  4. Baxter, Nancy. Preventive health care, 2001 update: Should women be routinely taught breast self-examination to screen for breast cancer?CMAJ ; 164 (13) June 26, 2001
  5. How best to teach women breast self-examination. A randomized controlled trial.  Annals Intern Med. 1990 May 15;112(10):772-9. Fletcher SW, O’Malley MS, Earp JL, Morgan TM, Lin S, Degnan D.