What Is Standard of Care, and Who Sets It in the Breast Cancer Trajectory?
Navigators constantly hear the phrase “standard of care,” but what does it essentially mean? Is it care that any patient can receive in the United States or country of patient origin? Does it revolve around the latest research or evidence-based practice? The National Cancer Institute defines it as “treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals.”1 The legal system uses it when discussing medical malpractice and claims it is based on what the physician of a specialty would routinely execute in comparable circumstances.2 In the world of breast cancer care, delay to diagnose in a timely manner, followed by an improperly performed procedure, were the most common reasons for malpractice in the United States.3
Interestingly, the history of defining standard of care involved 2 court cases, and the first had nothing to do with medical care. In 1932, a tugboat owner was sued after his vessel and the 2 barges it was moving sank during a storm.4 The barge owners claimed the tugboat was unsafe because it did not have the customary radio receiver onboard so the operator could have been warned of the storm and avoided transport. Since the practice of radios was reasonable, the tugboat owner was liable for damages. In 1974, a case went all the way to the Supreme Court of Washington State when a woman sued her ophthalmologist after she lost her eyesight attributable to glaucoma.5 The defendant used testimony from an expert witness that glaucoma was rare in the 40-year-old patient’s age range, and it was not usual practice to test for the disease. The Supreme Court ruled that the test should have been provided because it was an economical and safe procedure. This last case initiated individual state governments to pass statutes that defined standard, and the state of Washington was one of the first to pass this type of legislation.6
In breast cancer care, the standards that define and measure quality of care involve multiple organizations but are largely driven by the National Comprehensive Cancer Network (NCCN), the National Accreditation Program for Breast Centers (NAPBC) offered by the American College of Surgeons, and the American Society of Clinical Oncology (ASCO).7 There are others that pertain to and support best breast care, such as The American Society of Breast Surgeons and the Society of Surgical Oncology; the American College of Radiology and the Society of Breast Imaging for radiologists; the American Society for Radiation Oncology that updates guidelines for radiation oncologists; the American Society of Plastic Surgeons for reconstruction specialists, and the College of American Pathologists, which employs evidence-based guidelines in testing for breast cancer. Many of these specialized professional groups define and measure quality of breast care within their faction. In addition, the National Cancer Institute has treatment guidelines or summaries. On a personal professional level, there is certification by medical specialties, such as medical genetics, pathology, plastic surgery, and surgery, in addition to nursing specialty certification with Certified Breast Care Nurse.
The NCCN is composed of 28 cancer center institutions that have worked together over the past 25 years to develop and annually revise guidelines that detail sequential management decisions based on the best current evidence available for the majority of cancers.8 For breast guidelines, a panel comprises a broad representation of specialties and clinical expertise as well as patient advocates and primary care physicians. This group scrutinizes quality, quantity, and consistency of the most recent breast data to weigh the overall balance of therapeutic benefit, efficacy, safety, and toxicity before making recommendations.9 Table 1 reflects the consensus to include a standard for clinical policy in breast cancer care. Oncology healthcare professionals practice by these specific clinical care guidelines because they are a compendium for private insurers and the Centers for Medicare & Medicaid Services coverage.10
In 2008, the NAPBC was established by the American College of Surgeons to address the fragmented patient flow in breast care and optimize systemic care by internally assessing quality measure processes in breast centers.11 This primarily structural program is available to breast centers in academic medical centers, teaching hospitals, hospitals, freestanding centers, or private practices that volunteer and pay to participate in the triennial accreditation survey process to comply with the established standards. The accreditation process encompasses 28 individual standards around 17 components of treatment for breast cancer and benign breast diseases, including coordination of care via nurse navigation.12 It was the first national organization to require a navigation standard. The Standards and Accreditation Committee consists of representatives from the professional member organizations and advocacy partners who create the most recent evidence-based and consensus-developed criteria that are presented as a Breast Centers Standards Manual. In a recent study, Miller and colleagues showed that NAPBC-accredited centers achieved higher performance on most patient and facility quality measures compared with non-NAPBC centers, and, most importantly, breast cancer patients were receiving consistent guideline care.13
In 1964, ASCO was founded by 6 men and 1 woman to focus on issues distinctive to clinical oncology and the field of cancer chemotherapy.14 Now, the organization has 45,000 members worldwide and is governed by a 19-member board that uses volunteer members and leaders in patient advocacy groups to structure committees, editorial boards, task forces, panels, working groups, and advocacy groups to develop and publish evidence-based standards to provide frameworks for best practices in cancer care.15 The breast cancer clinical practice guidelines developed by a multidisciplinary panel of experts, inclusive of patient advocates, outline appropriate methods of treatment and care that address clinical situations, medical products, procedures, or tests.16 For example, Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx, released last year, addresses the use of Oncotype DX in guiding decisions on the use of adjuvant systemic therapy.17 Table 2 reflects the status assigned by ASCO on each guideline.16
How Navigators Support Breast Cancer Standard of Care
Proper treatment or evidence-based care that is widely used by healthcare professionals decreases breast cancer recurrence and increases survival, yet not all women receive or complete standard breast cancer care.18,19 Some reasons cited why breast cancer patients do not obtain systemic cancer treatments are patient refusal, absence of a physician recommendation, and healthcare barriers.20 It does matter for women to have access and understanding of standard breast care. Patient navigation can and does address these barriers and expedite timely access to quality standard care by providing personalized assistance to patients. The basic knowledge, role, and function of navigators reflect how they support appropriate care for all patients. The oncology patient navigator core competencies that support this necessity are:
- Assist patients in accessing cancer care and navigating healthcare systems. Assess barriers to care and engage patients and families in creating potential solutions to financial, practical, and social challenges
- Provide patients and caregivers evidence-based information and refer to clinical staff for questions about clinical information, treatment choices, and potential outcomes
- Demonstrate familiarity with and know how to access and reference evidence-based information regarding cancer screening, diagnosis, treatment, and survivorship
- Demonstrate familiarity with and know how to access and reference evidence-based information regarding cancer screening, diagnosis, treatment, and survivorship
- Communicate effectively with navigator colleagues, health professionals, and health-related agencies to promote patient navigation services and leverage community resources to assist patients
- Participate in interprofessional teams to provide patient- and population-centered care that is safe, timely, efficient, effective, and equitable21
The core competencies and knowledge base for an oncology nurse navigator to promote care transitions, guidance, education, and advocacy across the breast care continuum are:
- Community education prevention and screening (health screening guidelines/practices)
- Risk assessment (smoking, diet, occupation, etc)
- Genetics (family history)
- Identification/intervention of clinical and service barriers to care
- Patient care process/cancer care continuum (prevention/screening/risk assessment, diagnosis, clinical trials, treatment, survivorship/end-of-life care)
- Patient/family center education (screening, diagnosis, treatment, side effect management, survivorship/end of life)
- Tumor board
- NCCN guidelines (national guidelines specific to tumor type)
- Counseling: conduit between patient and providers
- Care planning22
It is a team effort among patient and nurse navigators to support breast cancer care across the continuum using the standards or guidelines that are established and recognized by their institution. As specific breast programs are using quality measures to evaluate their care, the Academy of Oncology Nurse & Patient Navigators (AONN+) navigation metrics can be conceptualized to work alongside them to demonstrate the impact navigation brings in promoting standards of care.
NCCN has specific guidelines on breast cancer risk reduction, screening, and diagnosis.23,24 The NAPBC standard expects the Breast Program Leadership Committee (BPLC) to adopt evidence-based breast disease patient management and genetic evaluation, as well as to provide 2 or more breast disease education, prevention, and/or early detection programs per year.25 AONN+ metrics that can support increased and timely screening standards are:
- Number of participants at cancer screening event and/or percentage increase of cancer screening
- Number of navigated patients per quarter with abnormal screening results referred for follow-up diagnostic workup
- Number of navigated individuals with abnormal screening results who completed diagnostic workup per month/quarter26
Since the original patient navigation study by Harold P. Freeman, MD, in the 1990s, breast navigators have made a difference in the community setting by getting women screened and obtaining access to further healthcare.27 In Connecticut, the area with the highest breast cancer mortality utilized nurse and patient navigation in an underserved area to increase screening.28 The nurse navigator supervised trained bilingual survivors who were peer role models and who encouraged women to participate in breast screening. They interacted with women in unique venues such as job training programs, parent groups, programs for the homeless, and at a church’s food pantry.
A 55% annual rescreening rate for women who had not been screened in 18 months or more was achieved by using patient navigators from their respective settings, as they interacted face-to-face or followed up by telephone contact around culturally specific community events.29 With the use of community navigators to provide outreach education and scheduling, cancer screening for a group of Asian and Pacific Islander Medicare beneficiaries who lived on a medically underserved island increased by 20%.30
A common facet of navigation care is barrier identification and resolution. Many navigation studies reflect that the type and number of barriers are predictive of the time to resolve abnormal breast results.31-33 Randomized navigation studies on resolution of breast abnormal screening demonstrate that navigated patients experienced a shorter time to results versus those in a non-navigated group.34,35
For treatment, the NCCN has detailed guidelines for noninvasive, invasive, Phyllodes, Paget’s, and inflammatory disease as well as breast cancer care during pregnancy.36 The NAPBC has standards that measure performance of surgical procedures, pathology, radiation oncology, medical oncology, reconstructive surgery, and clinical trial accrual.25 ASCO addresses specific treatment for breast cancer types or tests to select optimal breast care.16 AONN+ metrics that can apply to this continuum are:
- Percentage of navigated patients who adhere to institutional treatment pathways per quarter
- Number and list of specific barriers to care identified by navigator per month
- Number of patients educated on clinical trials by the navigator per month/number of navigated patients referred to clinical trial department per month
- Referrals to revenue-generating services/downstream revenue—number of patients referred to revenue-generating services (ie, radiology, rehabilitation, palliative care, tumor site–specific pre/rehab programs)
- Number of business days from diagnosis (date pathology resulted) to initial treatment modality (date of first treatment)26
For breast treatment standards, the patient and nurse navigator work within their scope of practice to support patients undergoing cancer therapy. The patient navigator continues to assess logistical barriers and scheduling conflicts to care while the nurse and social worker navigators, who understand the intricacies of the healthcare system and surrounding community, can individually educate, advocate, and counsel to facilitate timely, evidence-based care.37 Among safety net hospitals using navigators to promote communication, assessment, and adherence of treatment recommendations there was a decrease in time to definitive therapy and a higher percentage to start treatment within 30 days.37,38 When a nurse navigator evaluates internal processes of wait time and targets specific interventions, this results in a decrease in time to treatment.39,40 When the nurse navigator proactively references the NCCN guidelines and facilitates appropriate staging studies per the medical oncologist’s direction, additional time savings in the medical oncology visits can also produce a positive financial return on investment.41 To avoid care delays, navigators can identify women early in the process who might benefit from seeing a credentialed genetics professional for further evaluation because this can influence surgical and treatment decisions for a patient.42,43 To promote earlier chemotherapy initiation, nurse navigators have performed a gap analysis in the breast care continuum and worked with the breast care team to improve timing of care.44,45 Patient and nurse navigators have demonstrated their value in increasing accrual to clinical trials.46,47
Metastatic or Advanced Disease
The care for metastatic breast cancer continues to increase as survivors recur. Endocrine-positive recurrence rates within 5 to 20 years after taking hormone therapy for 5 years range from 10% to 17%.48 One in 4 HER2-positive patients who received 1 year of trastuzumab experienced recurrence within 10 years.49 The NCCN has guidelines for stage IV or recurrent breast cancer that are subdivided into local or regional disease.36 The NAPBC directs the BPLC to develop a process for use of the American Joint Committee on Cancer staging in defining treatment for breast cancer patients.25 ASCO addresses issues such as Role of Bone-Modifying Agents in Metastatic Breast Cancer Update and Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer.16 The same AONN+ metrics that apply to treatment standards can be repeated with this population.
With the surge in oral therapy for estrogen-positive metastatic breast cancer, navigators may be able to help with treatment initiation.50 Navigators have made a difference in assisting older women to access breast care, particularly addressing knowledge deficits, comorbidities, and multiple appointments with healthcare professionals.51 A proactive discussion on patient goals is a priority with metastatic disease, and navigators can guide patients and families in conversation and refer them to palliative care resources as needed.52,53
Modern breast cancer care takes a multidisciplinary approach that is characterized by evidence-based clinical medicine that targets patients’ tumor biological characteristics in an environment that is attentive to the array of patient needs and uses system-based care to achieve patient-centered care delivery goals. Consistently using evidence-based guidelines as quality measures for all breast care can sustain positive long-term clinical outcomes. Navigators are a valuable addition to this team and employ appropriate use of the evidence-based or standard of care to promote survival and quality of life.
- National Cancer Institute. NCI Dictionary of Cancer Terms. Standard of Care. www.cancer.gov/publications/dictionaries/cancer-terms/def/standard-of-care.
- Goguen D. What is the Medical Standard of Care? NoLo. www.alllaw.com/articles/nolo/medical-malpractice/standard-of-care.html. 2019
- Murphy BL, Ray-Zack MD, Reddy PN, et al. Breast cancer litigation in the 21st century. Ann Surg Oncol. 2018;25:2939-2947.
- The T.J. Hooper, 60 F:2d 737 (2d Cir.), cert. denied, 287 U.S. 662 (1932).
- Helling v. Carey, 83 Wash. 2d 514, 519 P.2d 981 (1974).
- Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12:109-112.
- Masood S. Moving toward appropriateness of breast cancer care: a balanced act to redefine the scope of standard of care. Womens Health (Lond). 2016;12:163-166.
- National Comprehensive Cancer Network. About the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). www.nccn.org/professionals.
- National Comprehensive Cancer Network. Development and Update of the NCCN Guidelines. Introduction. www.nccn.org/professionals/development.aspx.
- Wagner J, Marquart J, Ruby J, et al. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study. BMJ. 2018;360:k668.
- Winchester D. The United States’ national accreditation program for breast centers: a model for excellence in breast disease evaluation and management. Chin Clin Oncol. 2016;5:31.
- American College of Surgeons. NAPBC Accreditation. www.facs.org/quality-programs/napbc/accreditation.
- Miller M, Bleicher RJ, Kaufman CS, et al. Impact of breast center accreditation on compliance with breast quality performance measures at Commission on Cancer-accredited centers. Ann Surg Oncol. 2019;26:1202-1211.
- American Society of Clinical Oncology. Founders. www.asco.org/about-asco/asco-overview/society-history/founders.
- American Society of Clinical Oncology. ASCO Overview. www.asco.org/about-asco/asco-overview.
- American Society of Clinical Oncology. Breast Cancer. www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer.
- American Society of Clinical Oncology. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer. www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9746.
- Gaitanidis A, Alevizakos M, Tsalikidis C, et al. Refusal of cancer-directed surgery by breast cancer patients: risk factors and survival outcomes. Clin Breast Cancer. 2018;18:e469-e476.
- Han E, Johnson N, DelaMelena T. et al. Alternative therapy used as primary treatment for breast cancer negatively impacts outcomes. Ann Surg Oncol. 2011;18:912-916.
- Saquib J, Parker BA, Natarajan L, et al. Prognosis following the use of complementary and alternative medicine in women diagnosed with breast cancer. Complement Ther Med. 2012;20:283-290.
- Academy of Oncology Nurse & Patient Navigators. Core Competencies for an Oncology Patient Navigator–Certified Generalist. https://aonnonline.org/certification/oncology-patient-navigator-certified-generalist-opn-cg-certification.
- Core Competencies for an Oncology Nurse Navigator–Certified Generalists. https://aonnonline.org/certification/oncology-nurse-navigator-certified-generalist-onn-cg-certification.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer Risk Reduction. www.nccn.org/professionals/physician_gls/pdf/breast_risk.pdf.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer Screening and Diagnosis. www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf.
- American College of Surgeons. National Accreditation Program For Breast Centers Standards Manual. https://accreditation.facs.org/accreditationdocuments/NAPBC/Portal%20Resources/2018NAPBCStandardsManual.pdf.
- Academy of Oncology Nurse & Patient Navigators. Standardized Metrics Source Document. https://aonnonline.org/metrics-source-document.
- Freeman HP. The history, principles, and future of patient navigation: commentary. Semin Oncol Nurs. 2013;29:72-75.
- Cascella S, Keren J. Mujer a mujer/woman to woman: using a unique venue for culturally appropriate outreach and navigation in an underserved area to increase screening. Journal of Oncology Navigation & Survivorship. 2012;3(2):20-26.
- Burhansstipanov L, Dignan MB, Schumacher A, et al. Breast screening navigator programs within three settings that assist underserved women. J Cancer Edu. 2010;25:247-252.
- Braun KL, Thomas WL Jr, Domingo JL, et al. Reducing cancer screening disparities in Medicare beneficiaries through cancer patient navigation. J Am Geriatr Soc. 2015;63:365-370.
- Krok-Schoen JL, Brewer BM, Young GS, et al. Participants’ barriers to diagnostic resolution and factors associated with needing patient navigation. Cancer. 2015;121:2757-2764.
- Ramachandran A, Freund KM, Bak SM, et al. Multiple barriers delay care among women with abnormal cancer screening despite patient navigation. J Womens Health (Larchmt). 2015;24:30-36.
- Krok-Schoen JL, Kurta ML, Weier RC, et al. Clinic type and patient characteristics affecting time to resolution after an abnormal cancer-screening exam. Cancer Epidemiol Biomarkers Prev. 2015;24:162-168.
- Paskett ED, Katz ML, Post DM, et al. The Ohio Patient Navigation Research Program: does the American Cancer Society patient navigation model improve time to resolution in patients with abnormal screening tests? Cancer Epidemiol Biomarkers Prev. 2012;21:1620-1628.
- Markossian TW, Darnell JS, Calhoun EA. Follow-up and timeliness after an abnormal cancer screening among underserved, urban women in a patient navigation program. Cancer Epidemiol Biomarkers Prev. 2012;21:1691-1700.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Breast Cancer. Version 2.2019. www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
- Ramirez A, Perez-Stable E, Penedo F, et al. Reducing time-to-treatment in underserved Latinas with breast cancer: the Six Cities Study. Cancer. 2014;120:752-760.
- Haideri NA, Moormeier JA. Impact of patient navigation from diagnosis to treatment in an urban safety net breast cancer population. J Cancer. 2011;2:467-473.
- Koh C, Nelson JM, Cook PF. Evaluation of a patient navigation program. Clin J Oncol Nurs. 2011;15:41-48.
- Basu M, Linebarger J, Gabram SG, et al. The effect of nurse navigation on timeliness of breast cancer care at an academic comprehensive cancer center. Cancer. 2013;119:2524-2531.
- Christensen D. Using a nurse navigation pathway in the timely care of oncology patients. Journal of Oncology Navigation & Survivorship. 2014;5(3):13-18.
- Bellcross CA, Leadbetter S, Alford SA, Peipins LA. Prevalence and healthcare actions of women in a large health system with a family history meeting the 2005 USPSTF recommendation for BRCA genetic counseling referral. Cancer Epidemiol Biomarkers Prev. 2013;22:728-735.
- Malone P, Bruno L, Hayden B, Carlson J. Development and evolution of an oncology nurse navigation program: from formation to fruition. Journal of Oncology Navigation & Survivorship. 2014;5(5):19-24.
- Shockney LD. The evolution of patient navigation and survivorship care. Breast J. 2015:21:104-110.
- McAllister KA, Schmitt ML. Impact of a nurse navigator on genomic testing and timely treatment decision making in patients with breast cancer. Clin J Oncol Nurs. 2015;19:510-512.
- Holmes DR, Major J, Lyonga DE, et al. Increasing minority patient participation in cancer clinical trials using oncology nurse navigation. Am J Surg. 2012;203:415-422.
- St Germain D, Dimond E, Olesen K. et al. The NCCCP Patient Navigation Project: using patient navigators to enhance clinical trial education and promote accrual. Oncology Issues. 2014;29(3):44-53.
- Pan H, Gray R, Braybrooke J, et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377:1836-1846.
- Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial [published correction appears in Lancet. 2019;393:1100]. Lancet. 2017;389:1195-1205.
- Ko NY, Darnell JS, Calhoun E, et al. Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program. J Clin Oncol. 2014;32:2758-2764.
- Pieters HC, Heilemann MV, Grant M, Maly RC. Older women’s reflections on accessing care across their breast cancer trajectory: navigating beyond the triple barriers. Oncol Nurs Forum. 2011;38:175-184.
- Hauser J, Sileo M, Araneta N, et al. Navigation and palliative care. Cancer. 2011;117:3585-3591.
- Fischer SM, Cervantes L, Fink RM, Kutner JS. Apoyo con Cariño: a pilot randomized controlled trial of a patient navigator intervention to improve palliative care outcomes for Latinos with serious illness. J Pain Symptom Manage. 2015;49:657-665.