Chemoprevention for Primary Breast Cancer Risk Reduction for Women at High Risk of Breast Cancer: Implementing an Evidence-Based Recommendation

This capstone project was an evidence-based quality improvement project with three objectives: (a) to understand current practice of primary breast cancer chemoprevention in an integrated health system; (b) to evaluate the most current evidence available and the U.S. Preventive Services Task Force’s (2013) Breast Cancer: Medications for Risk Reduction recommendation; and (c) to plan for implementation of the recommendation as a clinical practice guideline and evaluate the guideline outcomes through a future pilot study. The pilot study was not part of the capstone but included for planning purposes. Evidence exists of the effectiveness of selective estrogen receptor modulators and aromatase inhibitors for risk reduction of primary breast cancer for women at high risk for the development of breast cancer. Recommendations have been published by national prevention and oncology organizations advocating use of these pharmacologic agents in the high-risk female population. Despite good evidence, the use of medications to prevent breast cancer among women at high risk has not been put into practice. Local data support that women at high risk of breast cancer have not been educated about nor offered medications to reduce their risk. A Delphi method was used to understand obstacles to recommendation of chemoprevention and strategies to facilitate discussions with high-risk women. The development and implementation of a clinical practice guideline for breast cancer risk reduction would increase use of current evidence consistent with national standards of care, inform women of options for breast cancer risk reduction, and engage healthcare providers in shared decision-making with women relevant to breast cancer risks

Development of a Personalized Decision Aid for Breast Cancer Risk Reduction and Management

Background: Breast cancer risk reduction has the potential to decrease the incidence of the disease, yet remains underused. We report on the development a web-based tool that provides automated risk assessment and personalized decision support designed for collaborative use between patients and clinicians. Methods: Under Institutional Review Board approval, we evaluated the decision tool through a patient focus group, usability testing, and provider interviews (including breast specialists, primary care physicians, genetic counselors). This included demonstrations and data collection at two scientific conferences (2009 International Shared Decision Making Conference, 2009 San Antonio Breast Cancer Symposium). Results: Overall, the evaluations were favorable. The patient focus group evaluations and usability testing (N = 34) provided qualitative feedback about format and design; 88% of these participants found the tool useful and 94% found it easy to use. 91% of the providers (N = 23) indicated that they would use the tool in their clinical setting. Conclusion: BreastHealthDecisions.org represents a new approach to breast cancer prevention care and a framework for high quality preventive healthcare. The ability to integrate risk assessment and decision support in real time will allow for informed, value-driven, and patient-centered breast cancer prevention decisions. The tool is being further evaluated in the clinical setting

Consensus Recommendations for Advancing Breast Cancer: Risk Identification and Screening in Ethnically Diverse Younger Women

A need exists for a breast cancer risk identification paradigm that utilizes relevant demographic, clinical, and other readily obtainable patient-specific data in order to provide individualized cancer risk assessment, direct screening efforts, and detect breast cancer at an early disease stage in historically underserved populations, such as younger women (under age 40) and minority populations, who represent a disproportionate number of military beneficiaries. Recognizing this unique need for military beneficiaries, a consensus panel was convened by the USA TATRC to review available evidence for individualized breast cancer risk assessment and screening in young (< 40), ethnically diverse women with an overall goal of improving care for military beneficiaries. In the process of review and discussion, it was determined to publish our findings as the panel believes that our recommendations have the potential to reduce health disparities in risk assessment, health promotion, disease prevention, and early cancer detection within and in other underserved populations outside of the military. This paper aims to provide clinicians with an overview of the clinical factors, evidence and recommendations that are being used to advance risk assessment and screening for breast cancer in the military

The WISDOM Study: breaking the deadlock in the breast cancer screening debate.

There are few medical issues that have generated as much controversy as screening for breast cancer. In science, controversy often stimulates innovation; however, the intensely divisive debate over mammographic screening has had the opposite effect and has stifled progress. The same two questions-whether it is better to screen annually or bi-annually, and whether women are best served by beginning screening at 40 or some later age-have been debated for 20 years, based on data generated three to four decades ago. The controversy has continued largely because our current approach to screening assumes all women have the same risk for the same type of breast cancer. In fact, we now know that cancers vary tremendously in terms of timing of onset, rate of growth, and probability of metastasis. In an era of personalized medicine, we have the opportunity to investigate tailored screening based on a woman's specific risk for a specific tumor type, generating new data that can inform best practices rather than to continue the rancorous debate. It is time to move from debate to wisdom by asking new questions and generating new knowledge. The WISDOM Study (Women Informed to Screen Depending On Measures of risk) is a pragmatic, adaptive, randomized clinical trial comparing a comprehensive risk-based, or personalized approach to traditional annual breast cancer screening. The multicenter trial will enroll 100,000 women, powered for a primary endpoint of non-inferiority with respect to the number of late stage cancers detected. The trial will determine whether screening based on personalized risk is as safe, less morbid, preferred by women, will facilitate prevention for those most likely to benefit, and adapt as we learn who is at risk for what kind of cancer. Funded by the Patient Centered Outcomes Research Institute, WISDOM is the product of a multi-year stakeholder engagement process that has brought together consumers, advocates, primary care physicians, specialists, policy makers, technology companies and payers to help break the deadlock in this debate and advance towards a new, dynamic approach to breast cancer screening

Effectiveness of interventions to identify and manage patients with familial cancer risk in primary care: a systematic review

This systematic review evaluated the effectiveness of strategies to identify and manage patients with familial risk of breast, ovarian, colorectal and prostate cancer in primary careto improve clinical outcomes. MEDLINE, EMBASE, CINAHL and Cochrane library were searched from January 1980 to October 2017. We included randomised controlled trials (RCT) and non-randomised studies of interventions (NRSI). Primary outcomes were cancer incidence, cancer related clinical outcomes or identification of cancer predisposition; secondary outcomes were appropriateness of referral, uptake of preventive strategies, cognitive and psychological effect. From 11842 abstracts, 111 full texts were reviewed and three eligible studies (nine articles) identified. Two were cluster RCTs and one NRSI; all used risk assessment software. No studies identified our primary outcomes, with no consistent outcome across the three studies. In one RCT, intervention improved the proportion of genetic referrals meeting referral guidelines for breast cancer (OR 4.5, 95% CI 1.6 to 13.1). In the other RCT, there was no difference in screening adherence between the intervention and control group. However, there was borderline increased risk perception (OR 1.89, 95% CI 0.99 to 3.59) in the subgroup that under-estimated their colon cancer risk. In the NRSI, there was no change in psychological distress inpatients at increased familial breast cancer risk, but population risk patients had reduced anxiety after intervention (state anxiety mean change –3,95% CI -5 to -2). Future studies should have better defined comparator groups, longer follow up, and assess outcomes using validated tools

Genomics and population health: United States 2003

Foreword -- Genomics and Population Health, 2003: Year at a Glance -- Genomics Lingo\ue2?\ub5..What Do the Terms Mean? -- List of Authors -- -- I. Population Health Research -- Chapter 1. National Health and Nutrition Examination Survey (NHANES) III DNA Bank: Gene Variants Important to Public Health -- Chapter 2. Genomics and Acute Public Health Investigations -- -- II. Building the Evidence Base -- Chapter 3. Asthma Genomics: Implications for Public Health -- Chapter 4. Public Health Assessment of BRCA1 and BRCA2 Testing for Breast and Ovarian Cancer -- Chapter 5. Newborn Screening for MCAD Deficiency -- Chapter 6. The Family History Public Health Initiative -- Chapter 7. Genetic Testing and the Prevention of Coronary Heart Disease: A Case Study -- Chapter 8. Genomics and Public Health: Ethical, Legal, and Social Issues -- -- III. Genomics in Practice -- Chapter 9. Carrier Testing for Cystic Fibrosis: Transition from Research to Clinical Practice -- Chapter 10. Ensuring the Quality of Genetic Testing in the United States -- Chapter 11. Hemochromatosis: Information and Resources for Health Care Providers -- Chapter 12. Genomics Training for Public Health Practice: The Michigan Experience -- Chapter 13. Genomics Tools for Public Health -- Chapter 14. State Capacity Grants for Integrating Genomics into Chronic Disease Prevention Programs -- Chapter 15. Internet Resources for Genomics and Disease Prevention[edited by Marta Gwinn ... [et al.]]."March 2004."Also available via World Wide Web

Medically-defined risk and the engagement of patients in health services: a multi-level perspective

Identifying and communicating a disease diagnosis has historically been the center of the medical encounter. Recent advances in molecular biology and genetics have increased the amount of care devoted to disease screening and risk assessment. In this era of prevention, risk itself has become a ‘problem’ requiring intervention where once such problems were left unidentified. Treating risk as a diagnosis itself allows it be treated in a familiar manner, but marginalizes the patient experience. It is important to understand how adopting a biomedical view of risk and prevention influences participation in care and patient willingness to engage with the medical system, despite a lack of manifest disease. This is a critical gap in knowledge at a time when there is increased emphasis on preventive medicine. This dissertation contains three chapters that seek to characterize how identifying, labeling, and developing interventions for patients 'at risk' affects service provision and use. Study 1, Explanatory Models of Risk: The Role of Social Context in Breast Cancer Risk Perception and Decision-Making, sought to characterize explanatory models of risk among women at risk for developing breast cancer. Qualitative interviews demonstrated the importance of perceptions of risk and control in combination with elements of explanatory models and social context in their decision-making. Study 2, Associations between Breast Cancer Risk and General Health Service Use, considered the possibility that patterns of health service utilization may change following a medical finding that is often perceived as increased risk. Results showed a greater increase in the rate of outpatient visits and referrals in the year following a false positive mammogram, suggesting such utilization is driven by both patients and providers. Study 3, An Assessment of Patient Navigator Activities in Breast Cancer Patient Navigation Programs Using a Nine-Principle Framework, described similarities and differences in the execution of patient navigation programs designed to increase engagement in care among individuals who have been labeled as ‘at risk’ upon having an abnormal mammogram. Activities conducted by navigators where shown to vary according to the local context and population of women that they served

ECCO Essential Requirements for Quality Cancer Care: Primary care.

ECCO Essential Requirements for Quality Cancer Care (ERQCC) are checklists and explanations of organisation and actions that are necessary to give high-quality care to cancer patients. They are written by European experts representing all disciplines involved in cancer care. This paper concerns the integration of primary care into care for all cancers in Europe. Primary care integration

Critical research gaps and translational priorities for the successful prevention and treatment of breast cancer

INTRODUCTION Breast cancer remains a significant scientific, clinical and societal challenge. This gap analysis has reviewed and critically assessed enduring issues and new challenges emerging from recent research, and proposes strategies for translating solutions into practice. METHODS More than 100 internationally recognised specialist breast cancer scientists, clinicians and healthcare professionals collaborated to address nine thematic areas: genetics, epigenetics and epidemiology; molecular pathology and cell biology; hormonal influences and endocrine therapy; imaging, detection and screening; current/novel therapies and biomarkers; drug resistance; metastasis, angiogenesis, circulating tumour cells, cancer 'stem' cells; risk and prevention; living with and managing breast cancer and its treatment. The groups developed summary papers through an iterative process which, following further appraisal from experts and patients, were melded into this summary account. RESULTS The 10 major gaps identified were: (1) understanding the functions and contextual interactions of genetic and epigenetic changes in normal breast development and during malignant transformation; (2) how to implement sustainable lifestyle changes (diet, exercise and weight) and chemopreventive strategies; (3) the need for tailored screening approaches including clinically actionable tests; (4) enhancing knowledge of molecular drivers behind breast cancer subtypes, progression and metastasis; (5) understanding the molecular mechanisms of tumour heterogeneity, dormancy, de novo or acquired resistance and how to target key nodes in these dynamic processes; (6) developing validated markers for chemosensitivity and radiosensitivity; (7) understanding the optimal duration, sequencing and rational combinations of treatment for improved personalised therapy; (8) validating multimodality imaging biomarkers for minimally invasive diagnosis and monitoring of responses in primary and metastatic disease; (9) developing interventions and support to improve the survivorship experience; (10) a continuing need for clinical material for translational research derived from normal breast, blood, primary, relapsed, metastatic and drug-resistant cancers with expert bioinformatics support to maximise its utility. The proposed infrastructural enablers include enhanced resources to support clinically relevant in vitro and in vivo tumour models; improved access to appropriate, fully annotated clinical samples; extended biomarker discovery, validation and standardisation; and facilitated cross-discipline working. CONCLUSIONS With resources to conduct further high-quality targeted research focusing on the gaps identified, increased knowledge translating into improved clinical care should be achievable within five years

Final Report: The Practice and Impact of Shared Decision-Making

Several recent developments are likely to address those factors seen as contributing to shared decision-making’s mixed results: the lack of a nationally recognized certification process; insufficient funds to adequately invest in the training and infrastructure to support shared decision-making; and adequate methods for monitoring its effectiveness