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PURPOSE Breast cancer risk prediction models are used to identify high-risk women for early detection, targeted interventions, and enrollment into prevention trials. We sought to develop and evaluate a risk prediction model for breast cancer in US Black women, suitable for use in primary care settings. METHODS Breast cancer relative risks and attributable risks were estimated using data from Black women in three US population-based case-control studies (3,468 breast cancer cases; 3,578 controls age 30-69 years) and combined with SEER age- and race-specific incidence rates, with incorporation of competing mortality, to develop an absolute risk model. The model was validated in prospective data among 51,798 participants of the Black Women's Health Study, including 1,515 who developed invasive breast cancer. A second risk prediction model was developed on the basis of estrogen receptor (ER)–specific relative risks and attributable risks. Model performance was assessed by calibration (expected/observed cases) and discriminatory accuracy (C-statistic). RESULTS The expected/observed ratio was 1.01 (95% CI, 0.95 to 1.07). Age-adjusted C-statistics were 0.58 (95% CI, 0.56 to 0.59) overall and 0.63 (95% CI, 0.58 to 0.68) among women younger than 40 years. These measures were almost identical in the model based on estrogen receptor–specific relative risks and attributable risks. CONCLUSION Discriminatory accuracy of the new model was similar to that of the most frequently used questionnaire-based breast cancer risk prediction models in White women, suggesting that effective risk stratification for Black women is now possible. This model may be especially valuable for risk stratification of young Black women, who are below the ages at which breast cancer screening is typically begun.

PURPOSE: Healthcare systems contribute to disparities in breast cancer outcomes. Patient navigation is a widely cited systembased approach to improve outcomes among populations at risk for delays in care. Patient navigation programs exist in all major Boston hospitals, yet disparities in outcomes persist. The objective of this study was to conduct a baseline assessment of navigation processes at six Boston hospitals that provide breast cancer care in preparation for an implementation trial of standardized navigation across the city. METHODS: We conducted a mixed methods study in six hospitals that provide treatment to breast cancer patients in Boston. We administered a web-based survey to clinical champions (n = 7) across six sites to collect information about the structure of navigation programs. We then conducted in-person workflow assessments at each site using a semi-structured interview guide to understand site-specific implementation processes for patient navigation programs. The target population included administrators, supervisors, and patient navigators who provided breast cancer treatment-focused care. RESULTS: All sites offered patient navigation services to their patients undergoing treatment for breast cancer. We identified wide heterogeneity in terms of how programs were funded/resourced, which patients were targeted for navigation, the type of services provided, and the continuity of those services relative to the patient’s cancer treatment. CONCLUSIONS: The operationalization of patient navigation varies widely across hospitals especially in relation to three core principles in patient navigation: providing patient support across the care continuum, targeting services to those patients most likely to experience delays in care, and systematically screening for and addressing patients’ health-related social needs. Gaps in navigation across the care continuum present opportunities for intervention. TRIAL REGISTRATION: Clinical Trial Registration Number NCT03514433, 5/2/2018

Mammography remains the only validated screening tool for breast cancer, however, there are limitations to mammography. One of the limitations of mammography is the variable sensitivity based on breast density. Supplemental screening may be considered based on the patient’s risk level and breast density. For average-risk women with nondense breasts, the sensitivity of digital breast tomosynthesis (DBT) screening is high; additional supplemental screening is not warranted in this population. For average-risk women with dense breasts, given the decreased sensitivity of mammography/DBT, this population may benefit from additional supplemental screening with contrast-enhanced mammography, screening ultrasound (US), breast MRI, or abbreviated breast MRI. In intermediate-risk women, there is emerging evidence suggesting that women in this population may benefit from breast MRI or abbreviated breast MRI. In intermediate-risk women with dense breasts, given the decreased sensitivity of mammography/DBT, this population may benefit from additional supplemental screening with contrast-enhancedmammography or screening US. There is strong evidence supporting screening high-risk women with breast MRI regardless of breast density. Contrast-enhanced mammography, whole breast screening US, or abbreviated breast MRI may be also considered. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.

Objective Understanding whether states’ breast density notifications are associated with desired effects, or disparities, can inform federal policy. We examined self-reported receipt of personal breast density information, breast density discussions with providers, knowledge about density’s masking effect, and association with increased breast cancer risk by state legislation status and women’s sociodemographic characteristics. Methods Cross-sectional observational population-based telephone survey of women aged >40 years who underwent mammography within prior 2 years, had no history of breast cancer, and had heard the term “breast density.” Results Among 2,306 women, 57% received personal breast density information. Multivariate regression models adjusted for covariates indicated that women in notification states were 1.5 times more likely to receive density information, and older Black and Asian women of lower income and lower health literacy were less likely. Overall, only 39% of women discussed density with providers; women in notification states were 1.75 times as likely. Older and Asian women were less likely to have spoken with providers; women with high literacy or prior biopsy were more likely. State legislation status was not associated with differences in density knowledge, but Hispanic women and women of lower income or low health literacy had less knowledge regarding density’s masking effects; older women were more knowledgeable. Hispanic women and women of lower income or low health literacy were more likely, and middle-aged women less likely, to recognize increased breast cancer risk. Discussion Some positive effects were observed, but sociodemographic disparities suggest tailoring of future breast density communications for specific populations of women to ensure equitable understanding.

Starting breast cancer screening at age 40 versus 50 may increase potential harms frequency with a small mortality benefit. Younger women’s screening decisions, therefore, may be complex. Shared decision-making (SDM) is recommended for women under 50 and may support women under 55 for whom guidelines vary. How women with limited health literacy (LHL) approach breast cancer screening decision-making is less understood, and most SDM tools are not designed with their input. This phenomenological study sought to characterize mammography counseling experiences among women with LHL and primary care providers (PCPs). Women ages 40–54 with LHL who had no history of breast cancer or mammogram within 9 months were approached before a primary care visit at a safety-net hospital. PCPs at this site were invited to participate. Qualitative interviews explored mammography counseling experiences. Patients also reviewed sample information materials. A constant comparison technique generated four themes salient to 25 patients and 20 PCPs: addressing family history versus comprehensive risk assessment; potential mammography harms discussions; information delivery preferences; and integrating pre-visit information tools. Findings suggest that current counseling techniques may not be responsive to patient-identified needs. Opportunities exist to improve how mammography information is shared and increase accessibility across the health literacy spectrum.

BACKGROUND: Limited health literacy is a driver of cancer disparities and associated with less participation in medical decisions. Mammography screening decisions are an exemplar of where health literacy may impact decision-making and outcomes. OBJECTIVE: To describe informational needs and shared decision-making (SDM) experiences among women ages 40–54 who have limited health literacy and primary care providers (PCPs). DESIGN: Qualitative, in-depth interviews explored experiences with mammography counseling and SDM. PARTICIPANTS: Women ages 40–54 with limited health literacy and no history of breast cancer or mammogram in the prior 9 months were approached before a primary care visit at a Boston academic, safety-net hospital. PCPs practicing at this site were eligible for PCP interviews. APPROACH: Interviews were audio-recorded and transcribed verbatim. A set of deductive codes for each stakeholder group was developed based on literature and the interview guide. Inductive codes were generated during codebook development. Codes were compared within and across patient and PCP interviews to create themes relevant to mammography decision-making. KEY RESULTS: The average age of 25 interviewed patients was 46.5; 18 identified as black, 3 as Hispanic, 2 as non-Hispanic white, and 2 had no recorded race or ethnicity. Of 20 PCPs, 15 were female; 12 had practiced for >5 years. Patients described a lack of technical (appropriate tests and what they do) and process (what happens during a mammogram visit) knowledge, viewing these as necessary for decision-making. PCPs were reluctant to engage patients with limited health literacy in SDM due to time constraints and feared that increased information might confuse patients or deter them from having mammograms. Both groups felt pre-visit education would facilitate mammography-related SDM during clinical visits. CONCLUSION: Both patients and PCPs perceived a need for tools to relay technical and process knowledge about mammography prior to clinical encounters to address the scope of information that patients with limited health literacy desired. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-06213-2) contains supplementary material, which is available to authorized users.

PURPOSE: Low health literacy (HL) and language negatively affect cancer screening and prevention behaviors; less is known about how they affect the patient’s experience during cancer treatment. This study explores associations among HL, spoken language, and dimensions of cancer-related needs within 6 months of receiving a breast cancer diagnosis. METHODS: Women speaking English, Spanish, or Haitian Creole, enrolled in a patient navigation study at diagnosis, completed a survey in their primary spoken language at baseline and 6 months to characterize their cancer-related needs. HL was measured using the Brief Health Literacy Screening Tool. Outcomes included the Cancer Needs Distress Inventory (CaNDI; n = 38 items) and the Communication and Attitudinal Self-Efficacy scale (CASE-Cancer) for cancer (n = 12 items). Linear regressions measured the impact of HL and language on total CaNDI and CASE-Cancer scale for cancer scores and subscales, adjusted for demographics. RESULTS: At baseline, 262 women participated and 228 (87%) followed up at 6 months. Of these, 38% had adequate HL, 33% had marginal HL, and 29% had inadequate HL. Women with inadequate or marginal HL had higher median baseline CaNDI scores ( P = .02) and lower self-efficacy scores ( P = .008), relative to those with adequate HL. Haitian-Creole speakers had significantly lower CANDI scores at baseline ( P = .03). Adjusting for demographics, differences in CaNDI scores at baseline remained significant for those with lower HL and Haitian-Creole speakers. At 6 months, differences in self-efficacy persisted for Haitian-Creole speakers. CONCLUSION: Findings suggest that interventions oriented to mitigating HL and language barriers might reduce distress at the time of diagnosis and improve self-efficacy over the course of treatment.

Introduction: Clinical and Translational Award (CTSA) programs are developing relevant training for researchers and community stakeholders participating in community-engaged research (CEnR). However, there is limited research exploring the ways community stakeholders and partners with key CEnR experiences can inform and shape training priorities for prospective CEnR scholars to build meaningful and equitable partnerships. Methods: This study conducted and analyzed online individual semi-structured in-depth interviews with community stakeholders (n = 13) engaged in CEnR to identify training priorities for graduate students and emerging scholars. Findings: Thematic analysis of 13 interview transcripts revealed four major training priorities for prospective scholars interested in engaging in CEnR: 1) researcher’s positionality, 2) equitable power sharing, 3) funding, and 4) ethics. Conclusion: Building equitable research partnerships was a central theme woven across all four training priorities. Further research should focus on examining the development, implementation, and evaluation of CEnR training in partnership with community stakeholders and partners with relevant CEnR experience. Adopting a collaborative approach to incorporate both community stakeholders and researchers’ priorities can align training competencies to better prepare scholars to engage in building research partnerships.

Highlights • HEALing Communities Study is a parallel-group cluster randomized controlled trial. • Communities That HEAL intervention’s goal is to reduce opioid overdose deaths. • Structured consensus decision-making strategy guided study measure development. • More than 80 study measure specifications and a common data model were developed. • The study will provide methodology and longitudinal community data for research., Background Opioid overdose deaths remain high in the U.S. Despite having effective interventions to prevent overdose deaths, there are numerous barriers that impede their adoption. The primary aim of the HEALing Communities Study (HCS) is to determine the impact of an intervention consisting of community-engaged, data-driven selection, and implementation of an integrated set of evidence-based practices (EBPs) on reducing opioid overdose deaths. Methods The HCS is a four year multi-site, parallel-group, cluster randomized wait-list controlled trial. Communities (n = 67) in Kentucky, Massachusetts, New York and Ohio are randomized to active intervention (Wave 1), which starts the intervention in Year 1 or the wait-list control (Wave 2), which starts the intervention in Year 3. The HCS will test a conceptually driven framework to assist communities in selecting and adopting EBPs with three components: 1) A community engagement strategy with local coalitions to guide and implement the intervention; 2) A compendium of EBPs coupled with technical assistance; and 3) A series of communication campaigns to increase awareness and demand for EBPs and reduce stigma. An implementation science framework guides the intervention and allows for examination of the multilevel contexts that promote or impede adoption and expansion of EBPs. The primary outcome, number of opioid overdose deaths, will be compared between Wave 1 and Wave 2 communities during Year 2 of the intervention for Wave 1. Numerous secondary outcomes will be examined. Discussion The HCS is the largest community-based implementation study in the field of addiction with an ambitious goal of significantly reducing fatal opioid overdoses.

These past months of the coronavirus disease-2019 (COVID-2019) pandemic have given us ample opportunity to reflect on the US health-care system. Despite overwhelming tragedy, it is an opportunity for us to learn and to change. As we postpone routine visits because of the pandemic, we worry about risks for patients who delay cancer screening. We use cervical cancer screening and prevention as an example of how we can use some “lessons learned” from the pandemic to prevent “collateral losses,” such as an increase in cancers. COVID-2019–related health-system changes, like the more rapid evaluation of diagnostic tests and vaccines, the transition to compensated virtual care for most counseling and education visits, and broadened access to home services, offer potential benefits to the delivery of cervical cancer screening and prevention. While we detail the case for cervical cancer prevention, many of the issues discussed are generalizable to other preventative measures. It would be a tragedy if the morbidity and mortality of COVID-2019 are multiplied because of additional suffering caused by delayed or deferred cancer screening and diagnostic evaluation—but maybe with creativity and reflection, we can use this pandemic to improve care.

PURPOSE: To investigate the association between pre- or perinatal factors and breast cancer risk among African American women. METHODS: Participants in the Black Women’s Health Study, a prospective cohort of 59,000 African American women, reported birth weight, preterm birth, twin or triplet status, maternal age at birth, birth order, and having been breastfed during infancy at various times during follow-up from 1997 to 2015. Numbers of incident cases ranged from 312 for breastfed analyses to 1,583 for twin or triplet analyses. Using multivariable Cox proportional hazards regression, we estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between each factor and breast cancer risk overall and by estrogen receptor (ER) status. RESULTS: Compared to birth weights of 5 lbs. 8 oz.−8 lbs. 13 oz., low (8 lbs. 13 oz.) birth weights were associated with increased breast cancer risk; HRs (95% CI) were 1.19 (0.98–1.44) and 1.26 (0.97–1.63), respectively. Associations were similar by ER status. Having been born to a mother aged ≥35 years vs.

Objective Currently, 30 US states mandate that radiologists notify women when dense breast tissue is found on mammography. Little is understood about how notifications are perceived by recipients. This qualitative study sought to understand how dense breast notifications (DBNs) impact women’s perceptions and their participation in follow-up care. Methods We assessed rates of DBN recall and conducted semi-structured telephone interviews with 30 English-speaking women ages 40 to 74 after receiving a DBN from a Massachusetts hospital. Content coding characterized women’s recall of the notification content, perceptions of breast density, and planned or actual participation in follow-up care. Results Most women (81%) recalled receiving a DBN, but few could recall specific content. Women described struggling to understand the meaning of breast density and created their own explanatory models of dense breasts that differed from medical explanations. Many women planned to or did talk with their doctors about breast density as a result of receiving the notification. Conclusions Women receiving DBNs have limited knowledge and many misperceptions about the implications of having dense breasts. Practice implications Educational support is needed to promote informed decision- making about breast cancer screening that incorporates personal risk in the setting of dense breast legislation.

RESEARCH OBJECTIVE: Little is known about the best process for selecting content for decision aids (DAs) on mammography screening. This analysis triangulates perspectives (experts, primary care providers, and patients) to understand areas of divergent and convergent input across stakeholder groups in developing a breast cancer screening DA for women ages 40–54 with limited health literacy. STUDY DESIGN: A 3‐round modified Delphi panel was conducted among national breast cancer screening and decision science experts. They rated the importance of 57 statements for possible inclusion in a breast cancer screening DA. Qualitative comments about each statement were collected via open‐ended text fields. Analysis was conducted following the RAND Appropriateness methodology. Separately, 25 women with limited health literacy (patients) and 20 primary care providers (PCPs) from outpatient clinics at a Boston‐based safety net hospital completed interviews exploring mammography‐related informational needs. To identify areas where stakeholder perspectives converged or diverged from each other, we conducted a qualitative synthesis using a constant comparison technique. Codes were developed and compared: (1) at the level of the individual interview; (2) within stakeholder groups; and, (3) across stakeholder groups. POPULATION STUDIED: Eight experts participated in the Delphi panel. Participants had an advanced degree (MD, PhD), > 3 years of either professional, clinical or research experience, and content expertise in breast cancer screening, health literacy, or DA design. Patients included mammography‐eligible, primary care patients ages 40–54 with upcoming visits, and limited health literacy as defined by a score of

Selective estrogen receptor modulators (SERMs) reduce breast cancer risk. Adoption of SERMs as prevention medication remains low. This is the first study to quantify social, cultural, and psychologic factors driving decision making regarding SERM use in women counseled on breast cancer prevention options. A survey study was conducted with women counseled by a health care provider (HCP) about SERMs. A statistical comparison of responses was performed between those who decided to use and those who decided not to use SERMs. Independent factors associated with the decision were determined using logistic regression. Of 1,023 participants, 726 made a decision: 324 (44.6%) decided to take a SERM and 402 (55.4%) decided not to. The most important factor for deciding on SERM use was the HCP recommendation. Other characteristics associated with the decision included attitudes and perceptions regarding medication intake, breast cancer worry, trust in HCP, family members with blood clots, and others' experiences with SERMs. The odds of SERM intake when HCP recommended were higher for participants with a positive attitude toward taking medications than for those with a negative attitude (Pinteraction = 0.01). This study highlights the importance of social and cultural aspects for SERM decision making, most importantly personal beliefs and experiences. HCPs' recommendations play a statistically significant role in decision making and are more likely to be followed if in line with patients' attitudes. Results indicate the need for developing interventions for HCPs that not only focus on the presentation of medical information but, equally as important, on addressing patients' beliefs and experiences. Cancer Prev Res; 10(11); 625–34. ©2017 AACR. See related editorial by Crew, p. 609

Background Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2–3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. Methods Translating Research Into Practice (TRIP) utilizes community engaged research methods to address breast cancer care delivery disparities. Four Massachusetts Clinical and Translational Science Institute (CTSI) hubs collaborated with the Boston Breast Cancer Equity Coalition (The Coalition) to implement an evidence-based care coordination intervention for Boston residents at risk for delays in breast cancer care. The Coalition used a community-driven process to define the problem of care delivery disparities, identify the target population, and develop a rigorous pragmatic approach. We chose a cluster-randomized, stepped-wedge hybrid type I effectiveness-implementation study design. The intervention implements three evidence-based strategies: patient navigation services, a shared patient registry for use across academic medical centers, and a web-based social determinants of health platform to identify and address barriers to care. Primary clinical outcomes include time to first treatment and receipt of guideline-concordant treatment, which are captured through electronic health records abstraction. We will use mixed methods to collect the secondary implementation outcomes of acceptability, adoption/penetration, fidelity, sustainability and cost. Conclusion TRIP utilizes an innovative community-driven research strategy, focused on interdisciplinary collaborations, to design and implement a translational science study that aims to more efficiently integrate proven health services interventions into clinical practice.

Background There is a need for guidelines on patient navigation activities to promote both the quality of patient navigation and the standards of reimbursement for these services because a lack of reimbursement is a major barrier to the implementation, maintenance, and sustainability of these programs. Methods A broad community-based participatory research process was used to identify the needs of patients for navigation. A panel of stakeholders of clinical providers was convened to identify specific activities for navigators to address the needs of patients and providers with the explicit goal of reducing delays in the initiation of cancer treatment and improving adherence to the care plan. Results Specific activities were identified that could be generalized to all patient navigation programs for care during active cancer management to address the needs of vulnerable communities. Conclusions Oncology programs that seek to implement lay patient navigation may benefit from the adoption of these activities for quality monitoring. Such activities are necessary as we consider reimbursement strategies for navigators without clinical training or licensure.

Background: Disparities in breast cancer care are a worsening problem, requiring effective interventions that seek to address the delivery of high quality cancer care. Evidence from interventions designed to improve timeliness of care routinely identify lack of social support as one of the biggest barriers to care. And, social support is associated with adherence to treatment and survival. This study explores predictors of social support in a diverse population of cancer patients. Patients and Methods: This is a secondary analysis of baseline preliminary data from participants enrolled in Project SUPPORT, a randomized controlled comparative effectiveness trial designed to evaluate the impact of patient navigation with or without legal support and services, among women diagnosed with Stages 0-4 breast cancer between 2014-2016. Upon enrollment (within one month of a cancer diagnosis) we administered the Medical Outcomes Survey (MOS) of social support to all participants. This validated survey tool addresses functional support, including an overall score (range 0-95) and 4 distinct domains: Emotional/Informational, Tangible, Affectionate and Positive Social Interaction. Using chi-squared and t-tests we compared MOS scores across socio-demographic variables: age, race, language, insurance, health literacy and marital status. Results: Of the 103 participants, mean age is 54.5 (SD = 10.6); 56% Hispanic, 19% Black, and 22% White and 2% identified as other; the majority had public insurance 76%; 66% speak English, 21% Spanish and 13% Haitian Creole. Only 36% have adequate health literacy as measured by the BRIEF. Only 32% are currently partnered. The overall mean total score for social support is 75.8 (+/- 23.6), median of 78.9 (range 60.5 – 98.7). Participants scored lowest in tangible support (mean score 67.7 +/- 33.1) and highest in affective support (83.5 +/- 25.8). Non-White participants scored significantly lower across all domains (mean overall MOS score 73.3 +/- 2.6) when compared with Whites (mean overall MOS score 84.5 +/- 4.8, p value = 0.04). There were no differences in MOS scores by language, insurance, literacy or marital status. Conclusion: This is the first study to describe social support scores (overall and specific domains) from the validated MOS survey tool among a racially diverse, urban cancer patient population. We found significant differences by race. Studies to identify risks for low social support can help inform future targeted interventions. Citation Format: Ko NY, Festa K, Gunn C, Bak S, Wang N, Nelson K, Flacks J, Morton S, Battaglia TA. Predictors of social support among newly diagnosed breast cancer patients seeking care at an urban safety net academic medical center [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-09.

Despite professional societies' emphasis on women's health in internal medicine (IM) resident curricula, national implementation has varied. This study describes IM program directors' perceptions of women's health topics that residents should master and the current state of women's health education in IM residency programs.We recruited 408 program directors of IM residency programs to complete an electronic cross-sectional survey. Participants were surveyed about expected resident mastery of twelve women's health topics in the context of their program's current characteristics, core curricula, and training opportunities.One hundred twelve IM program directors completed the survey (response rate 27%). The percentage of program directors who perceived that residents should master each of the twelve women's health topics ranged from 48% to 98%, with the most program directors expecting mastery of osteoporosis (N = 110, 98%), sexually transmitted infection (N = 110, 98%), and gender-specific cancer (N = 109, 97%). These topics, however, were not currently included in the core curricula of 6%-12% of programs. Programs offered varied opportunities in women's health, including dedicated women's health electives (N = 76, 68%), concentrations or tracks (N = 8, 7%), and continuity clinics (N = 15, 13%). Most program directors were interested (N = 90, 80%) in expanding women's health opportunities in their programs.While women's health topics were perceived by program directors as a priority for IM resident mastery, certain priority topics and training opportunities were limited. Additional studies are needed to explore barriers to expansion of resident education in women's health and potential solutions.

Given the momentum in adopting patient navigation into cancer care, there is a need to understand the contribution of specific navigator activities to improved clinical outcomes. A mixed-methods study combined direct observations of patient navigators within the Patient Navigation Research Program and outcome data from the trial. We correlated the frequency of navigator tasks with the outcome of rate of diagnostic resolution within 365 days among patients who received the intervention relative to controls. A focused content analysis examined those tasks with the strongest correlations between navigator tasks and patient outcomes. Navigating directly with specific patients (r = 0.679), working with clinical providers to facilitate patient care (r = 0.643), and performing tasks not directly related to their diagnostic evaluation for patients were positively associated with more timely diagnosis (r = 0.714). Using medical records for non-navigation tasks had a negative association (r = -0.643). Content analysis revealed service provision directed at specific patients improved care while systems-focused activities did not.

BACKGROUND Enrollment rates onto cancer clinical trials are low and reflect a small subset of the population of which even fewer participants come from populations of racial or ethnic diversity or low socioeconomic status. There is a need to increase enrollment onto cancer clinical trials with a focus on recruitment of a diverse, underrepresented patient population. OBJECTIVE To use the electronic medical record (EMR) to understand the eligibility and enrollment rates for all available cancer trials in the ambulatory care setting at an urban safety net hospital to identify specific strategies for enhanced accrual onto cancer clinical trials of diverse and underserved patients. METHODS A clinical trial screening note was created for the EMR by the clinical trials office at an urban safety net hospital. 847 cancer clinical trial screening notes were extracted from the EMR between January 1, 2010 and December 31, 2010. During that time, 99 cancer trials were registered for accrual, including clinical treatment, survey, data repository, imaging, and symptom management trials. Data on eligibility, enrollment status, and relationship to sociodemographic status were compared. LIMITATIONS This is a single-institution and retrospective study. CONCLUSIONS The findings demonstrate that a formal process of tracking cancer clinical trial screens using an EMR can document baseline rates of institution-specific accrual patterns and identify targeted strategies for increasing cancer clinical trial enrollment among a vulnerable patient population. Offering nontreatment trials may be an important and strategic method of engaging this vulnerable population in clinical research.

Breast cancer screening decision aids that help women understand their risk for cancer and available screening options can improve the quality of decision-making for women in their 40s, but existing decision aids do not address the needs of women with limited health literacy. We conducted a Delphi panel among breast cancer screening and decision science experts to determine content for a breast cancer screening decision aid for women ages 40-54 who have limited health literacy. Experts were those with an advanced degree (MD, PhD), at least 3 years of experience, and content expertise in breast cancer screening, health literacy, or decision aid design. Experts were invited via email to participate in an online Delphi panel, which aimed to establish consensus on decision aid content, guided by the International Patient Decision Aid Standards. Experts rated the importance of each item on a scale from 1 (not important) to 9 (very important), as well as how strong they felt the evidence was to support each. Open-ended responses explaining ratings were gathered, and in Round 1 experts were asked to nominate new items for inclusion. Following RAND methods, the 30th - 70th percentile range, central point, and asymmetry index were calculated for each item. From these values, a disagreement index was determined, and if the value was >1, indicating disagreement, the item was moved to the next round. Otherwise, consensus was established, and the item was omitted from future rounds. Between rounds, experts received a summary of their rating for each item relative to others, along with a summary of the open-ended explanations. The process was repeated for Rounds 2 and 3. 15 experts were invited, 9 agreed and 8 completed Round 1. All eight participants were female, with an average age of 53. Seven were white and 2 Asian. Five held medical doctorate degrees, 3 had PhDs. Seven experts completed all 3 rounds. Round 1 included 55 items, 30 of which obtained consensus (disagreement index < 1). 29 items were reviewed in Round 2 (25 from Round 1, plus 4 newly nominated items), 15 of which obtained consensus, leaving a final round of 14 items. In Round 3, 1 item achieved consensus, 4 items converged around uncertainty, and 9 did not reach consensus. Experts disagreed or were uncertain on the importance of including breast cancer risk factors and whether a description of the multiple screening modalities available should be included. Explanations for these items described balancing an ethical imperative to provide information and avoid paternalism while limiting information extraneous to the decision. While guidelines suggest that the age of initiating mammography and modalities used should involve an assessment of risk of developing breast cancer, experts did not agree about the inclusion of risk factor or modality information in a breast cancer screening decision aid for women with limited health literacy. Balancing detail with simplicity remains a challenge in determining content for decision support tools that seek to include a range of literacy levels. Citation Format: Christine M. Gunn, Tracy A. Battaglia, Michael K. Paasche-Orlow, Mara Schonberg, Ariel Maschke, Nancy R. Kressin. Using a Delphi panel to establish content for a breast cancer screening decision aid inclusive of women with limited health literacy [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-017.

Little is known about whether women residing in states with mandated dense breast notification (DBN) have improved awareness, knowledge, or discussion with their doctors, or whether there are disparities by sociodemographic characteristics. We conducted a cross-sectional, national telephone survey to assess the primary outcomes intended by DBN legislation: informing women about personal breast density, increasing awareness of its making effect and association with increased cancer risk, and prompting discussions with providers. Specific efforts were made to include women from all race/ethnic groups, education strata, and literacy levels. Women aged >40 reporting a mammogram in Overall, 39% had a discussion with their provider about breast density, with women in DBN states being 1.82 times more likely to have done so (95% CI= 1.40, 2.37). There were no differences between women in DBN vs. non-DBN states related to knowledge of masking bias (OR=.99, 0.71, 1.39) or understanding that breast density is a cancer risk factor (OR=0.93, 0.71, 1.22). Hispanic and lower income women had less knowledge about these topics. Interaction models failed to reveal moderating effects of state DBN status, indicating that DBN legislation does not appear to be mitigating or worsening the observed sociodemographic differences. Findings suggest that mandated DBNs have had partial success informing women about their breast density. However, we saw few indications that DBNs increased knowledge and observed less knowledge among women with low income, racial/ethnic minority status and lower literacy. This ‘one size fits all’ policy approach to relaying breast density information appears to be inadequate in reducing disparities in breast density awareness and knowledge. Citation Format: Nancy R. Kressin, Jolie Wormwood, Tracy A. Battaglia, Priscilla J. Slanetz, Christine M. Gunn. Mixed success and persistent disparities in outcomes related to breast density legislation: A national survey [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-079.

Highlights • Community engagement can improve the uptake and sustainability of evidence-based practices (EBPs). • The Healing Communities Study seeks to show how community engagement can support the adoption of EBPs for addressing the opioid crisis. • To reduce opioid overdose deaths a community-engaged, data driven planning process is being implemented in 67 highly impacted communities., Background The implementation of evidence-based practices to reduce opioid overdose deaths within communities remains suboptimal. Community engagement can improve the uptake and sustainability of evidence-based practices. The HEALing Communities Study (HCS) aims to reduce opioid overdose deaths through the Communities That HEAL (CTH) intervention, a community-engaged, data-driven planning process that will be implemented in 67 communities across four states. Methods An iterative process was used in the development of the community engagement component of the CTH. The resulting community engagement process uses phased planning steeped in the principles of community based participatory research. Phases include: 0) Preparation, 1) Getting Started, 2) Getting Organized, 3) Community Profiles and Data Dashboards, 4) Community Action Planning, 5) Implementation and Monitoring, and 6) Sustainability Planning. Discussion The CTH protocol provides a common structure across the four states for the community-engaged intervention and allows for tailored approaches that meet the unique needs or sociocultural context of each community. Challenges inherent to community engagement work emerged early in the process are discussed. Conclusion HCS will show how community engagement can support the implementation of evidence-based practices for addressing the opioid crisis in highly impacted communities. Findings from this study have the potential to provide communities across the country with an evidence-based approach to address their local opioid crisis; advance community engaged research; and contribute to the implementation, sustainability, and adoption of evidence-based practices. Trial registration ClinicalTrials.gov (NCT04111939).

BACKGROUND: Legislation requiring mammography facilities to notify women if they have dense breast tissue found on mammography has been enacted in 34 US states. The impact of dense breast notifications (DBNs) on women with limited English proficiency (LEP) is unknown. OBJECTIVE: This study sought to understand Spanish-speaking women’s experience receiving DBNs in a Massachusetts safety-net hospital. DESIGN: Eligible women completed one audio-recorded, semi-structured interview via telephone with a native Spanish-speaking research assistant trained in qualitative methods. Interviews were professionally transcribed verbatim and translated. The translation was verified by a third reviewer to ensure fidelity with audio recordings. PARTICIPANTS: Nineteen Spanish-speaking women ages 40–74 who received mammography with a normal result and recalled receiving a DBN. APPROACH: Using the verified English transcripts, we conducted a content analysis to identify women’s perceptions and actions related to receiving the notification. A structured codebook was developed. Transcripts were independently coded and assessed for agreement with a modification of Cohen’s kappa. Content codes were grouped to build themes related to women’s perceptions and actions after receiving a DBN. KEY RESULTS: Nineteen Spanish-speaking women completed interviews. Nine reported not receiving the notification in their native language. Four key themes emerged: (1) The novelty of breast density contributed to notification-induced confusion; (2) women misinterpreted key messages in the notification; (3) varied actions were taken to seek further information; and (4) women held unrealized expectations and preferences for follow-up. CONCLUSIONS: Not having previous knowledge of breast density and receiving notifications in English contributed to confusion about its meaning and inaccurate interpretations of key messages by Spanish speakers. Tools that promote understanding should be leveraged in seeking equity in risk-based breast cancer screening for women with dense breasts.

Background: Tamoxifen and raloxifene are two selective receptor modulators (SERMs) that have been shown to reduce the risk of developing breast cancer in women at increased risk of the disease. Both drugs are infrequently used in the general U.S. population. Increased knowledge about the risks and benefits of SERM use for breast cancer risk reduction does not lead to increased uptake of chemoprevention. We know little about what influences decision-making regarding breast cancer risk reduction with SERMs. Methods: To better understand what influences SERM decision-making for breast cancer risk reduction we conducted a survey study assessing social, environmental, and psychological factors that may influence a woman's decision. Women who talked to a health care provider (HCP) about SERM use (N=1,023) received a questionnaire immediately after the HCP visit that asked about the counseling session, sociodemographics, experiences with breast cancer, breast cancer risk, and risk perception. After its completion a second survey was administered that inquired about issues surrounding medication intake such as attitudes about taking medicines in general, trust in pharmaceutical companies, and in their HCP. A statistical comparison of survey responses was performed between those who decided to take a SERM and those who decided not to take a SERM. Logistic regression was used to determine a key set of independent factors associated with the decision. Results: Of the 1,023 women, 716 made a decision about SERM intake (70%) and were included in the study. Of those, 324 (45%) decided to take a SERM and 392 (55%) decided not to take a SERM. Of SERM users 89.8% received a recommendation to take a SERM by the HCP compared to 44.4% of non-users. Only 15.7% of SERM users reported never having had a breast biopsy compared to 26.3% of non-users. Overall, SERM users had a higher breast cancer risk, risk perception, and worry about getting breast cancer. In multivariate analysis 11 factors were identified as having independent association with SERM use, including: recommendation from HCP, attitudes and perceptions regarding medication intake, influenced by someone's breast cancer diagnosis, breast cancer worry, trust in HCP, a diagnosis of atypical hyperplasia, and others' experiences with SERM intake. Women who had one or more first degree relatives with breast cancer were less likely to take a SERM. Neither breast cancer risk nor risk perception influenced SERM decision-making. Discussion: Factors that influence SERM decision-making are related to women's personal experiences with breast cancer, their HCP, and attitudes towards medications. Conclusions: Social, environmental, and psychological factors proved to be more important for SERM decision-making than breast cancer risk or risk perception. In addition to presenting risks and benefits in counseling, the importance of personal experiences and attitudes for decision-making need to be considered to understand and support women's decision-making on SERM use for breast cancer risk reduction. SUPPORT: U10CA37377, -69974; -180868, -180822; -189867. Citation Format: Holmberg C, Bandos H, Fagerlin A, Bevers TB, Battaglia TA, Wickerham DL, McCaskill-Stevens W. Results from NRG oncology/NSABP protocol DMP-1: Women's decision-making in breast cancer risk reduction. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P6-10-01.

As part of the Patient Navigation Research Program, we examined the effect of patient navigation versus usual care on timely diagnostic follow-up, defined as clinical management for women with cervical abnormalities within accepted time frames.Participants from four Patient Navigation Research Program centers were divided into low- and high-risk abnormality groups and analyzed separately. Low-risk participants (n = 2088) were those who enrolled with an initial Pap test finding of atypical squamous cells of undetermined significance (ASCUS) with a positive high-risk human papillomavirus (HPV) serotype, atypical glandular cells, or low-grade squamous intraepithelial lesion (LGSIL). High-risk participants were those with an initial finding of high-grade squamous intraepithelial lesion (HGSIL) (n = 229). A dichotomous outcome of timely diagnostic follow-up within 180 days was used for the low-risk abnormality group and timely diagnostic follow-up within 60 days for the high-risk group, consistent with treatment guidelines. A logistic mixed-effects regression model was used to evaluate the intervention effect using a random effect for study arm within an institution. A backward selection process was used for multivariable model building, considering the impact of each predictor on the intervention effect.Low-risk women in the patient navigation arm showed an improvement in the odds of timely diagnostic follow-up across all racial groups, but statistically significant effects were only observed in non-English-speaking Hispanics (OR 5.88, 95% CI 2.81-12.29). No effect was observed among high-risk women.These results suggest that patient navigation can improve timely diagnostic follow-up among women with low-risk cervical abnormalities, particularly in non-English-speaking Hispanic women.

Background Infection with the human immunodeficiency virus (HIV) remains associated with a greater risk of anal cancer, despite widespread use of combination antiretroviral therapy. Evidence concerning the acceptability of anal cancer screening gives little attention to women. Because HIV-infected women have a high prevalence of depression and history of sexual trauma, understanding acceptability among this group is critical. Purpose We sought to assess barriers and motivators to participation in anal cancer screening research among a racial/ethnically diverse HIV-infected female population. Methods We conducted a survey based on the Health Belief Model to identify characteristics of women willing to participate in anal cancer screening research ( n = 200). Bivariate analyses examined associations between willingness to participate and sociodemographics, clinical characteristics, and health beliefs. Logistic regression modeled willingness to participate in research. Main Findings Of the women who participated, 37% screened positive for depression, 43% reported a high trauma history, and 36% screened positive for posttraumatic stress disorder. Overall, 65% reported willingness to participate in research. Those likely to participate were older, reported intravenous drug use as their HIV risk factor, and had a history of prior high-resolution anoscopy (HRA) compared with those unwilling to participate. The most commonly reported barrier to anal Pap testing was fear of pain. In adjusted analyses, a lack of fear of pain and prior experience with HRA significantly predicted willingness to participate. Conclusions Findings suggest that, to increase participation in anal Pap and HRA-related research for HIV-infected women, a single approach may not be adequate. Rather, we must harness patients' previous experiences and address psychosocial and financial concerns to overcome barriers to participation.

BACKGROUND There is limited understanding of the association between barriers to care and clinical outcomes within patient navigation programs. METHODS Secondary analyses of data from the intervention arms of the Patient Navigation Research Program were performed, which included navigated participants with abnormal breast and cervical cancer screening tests from 2007 to 2010. Independent variables were: 1) the number of unique barriers to care (0, 1, 2, or ≥3) documented during patient navigation encounters; and 2) the presence of socio-legal barriers originating from social policy (yes/no). The median time to diagnostic resolution of index screening abnormalities was estimated using Kaplan-Meier cumulative incidence curves. Multivariable Cox proportional hazards regression examined the impact of barriers on time to resolution, controlling for sociodemographics and stratifying by study center. RESULTS Among 2600 breast screening participants, approximately 75% had barriers to care documented (25% had 1 barrier, 16% had 2 barriers, and 34% had ≥3 barriers). Among 1387 cervical screening participants, greater than one-half had barriers documented (31% had 1 barrier, 11% had 2 barriers, and 13% had ≥3 barriers). Among breast screening participants, the presence of barriers was associated with less timely resolution for any number of barriers compared with no barriers. Among cervical screening participants, only the presence of ≥2 barriers was found to be associated with less timely resolution. Both types of barriers, socio-legal and other barriers, were found to be associated with delay among breast and cervical screening participants. CONCLUSIONS Navigated women with barriers resolved cancer screening abnormalities at a slower rate compared with navigated women with no barriers. Further innovations in navigation care are necessary to maximize the impact of patient navigation programs nationwide. Cancer 2015;121:4016–4024. © 2015 American Cancer Society.

Current breast cancer screening guidelines promote the use of shared decision making for women younger than 50 years of age, yet their effect on mammography utilization is largely unknown. This study aimed to examine the effect of two elements of shared decision making on the use of mammogram screening: patient-perceived choice and patient-provider communication. Data were obtained from HINTS 4, a nationally representative survey of the U.S. population, administered from 2011 to 2013. Choice was measured with the question "Has a doctor ever told you that you could choose whether or not to have a mammogram?" Communication was measured using a 7-item scale (range: 7-28; higher scores denote better communication). Binary logistic regression models assessed the effect of patient choice and communication on ever having a mammogram using weighted sample data. The sample included 1,085 women younger than 50 years of age: 31% of women perceived having a choice to undergo mammography. The mean patient-provider communication score was 22.8. Those who thought they were given a choice regarding mammography were more likely to have a mammogram relative to those who did not think a choice was given by the provider. Patient-provider communication had no significant association with mammography utilization. Patient perceived choice, but not patient-provider communication, is positively associated with mammography utilization in women younger than 50 years of age.

Background: Dense breasts on mammography independently increases breast cancer risk and decreases mammography sensitivity. Thirty-two states have adopted notification laws to raise awareness among women with dense breasts about supplemental screening. Little is known about these policies' impact on clinical practice among primary care providers (PCPs). Materials and Methods: This study explores PCP attitudes, knowledge, and the impact of the Massachusetts dense breast notification legislation on clinical practice after its enactment in 2015. An anonymous, online survey at two urban safety-net hospitals was administered in 2015–2016. Practicing MDs and nurse practitioners in primary care were invited to participate. Results: All 145 PCPs in general internal medicine at the two sites were e-mailed a survey link and 80 (55%) were completed. While 64 of 80 PCPs surveyed (80%) had some familiarity with the legislation, none identified the 8 required components of notifications contained in the Massachusetts legislation. Forty-nine percent (39/80) did not feel prepared to respond to patient questions about dense breasts. Forty-one percent (33/80) correctly identified that no current guidelines recommend the use of supplemental screening tests solely based on breast density and 85% (68/80) indicated interest in further training. Female and less experienced providers were more likely to be in favor of the legislation (49% vs. 11% by gender; 76% 20 years). Women practitioners (55%) who were more likely than men (17%, p = 0.01) to agree with the policy changed their discussions of mammography results with patients. Conclusions: PCPs feel underprepared to counsel women about breast density identified on mammography and its implications.

BACKGROUND Patient navigation improves the timely diagnosis of cancer among minorities, but little is known about the effects of patient and navigator race and language concordance on health outcomes. METHODS The authors investigated the effects of patient and navigator race and language concordance on the time to diagnosis of cancer screening abnormalities among participants in the Boston Patient Navigation Research Program, a clinical effectiveness trial for women who had breast or cervical cancer screening abnormalities identified from January 1, 2007 to December 31, 2008. Hazard ratios and 95% confidence intervals were estimated using proportional hazards regression adjusting for clinical and demographic factors. RESULTS In total, 1257 women had breast cancer screening abnormalities (n = 655) or cervical cancer screening abnormalities (n = 602) identified, and 56% were nonwhite. Language concordance was associated with timelier resolution for all patients in the cervical cancer screening abnormalities group during the first 90 days (adjusted hazard ratio, 1.46; 95% confidence interval, 1.18-1.80), and specifically for Spanish speakers during the first 90 days (adjusted hazard ratio, 1.43; 95% confidence interval, 1.10-1.84), but no difference was observed after 90 days for women who had cervical cancer screening abnormalities or at any time for those who had breast cancer screening abnormalities. Race concordance was associated with significant decreases in the time to diagnosis for minority women with breast and cervical cancer screening abnormalities in analyses stratified by race, but no differences were observed in analyses that included all women. CONCLUSIONS Patient navigator race and language concordance improved the timeliness of care in a minority population. Patient navigators who are racially/ethnically diverse and multilingual may help address barriers to care and improve cancer outcomes for low-income minorities. Cancer 2015;121:1477–1483. © 2015 American Cancer Society.

Objectives The presentation of risks and benefits in clinical practice is common particularly in situations in which treatment recommendations involve trade-offs. The treatment of breast cancer risk with selective estrogen receptor modulators (SERMs) is such a decision. We investigated the influence of health care provider (HCP) counseling on women’s decision-making. Methods Thirty breast cancer risk counseling sessions were recorded from April 2012–August 2013 at a comprehensive cancer center and at a safety-net, community hospital in the US. Participating women and HCPs were interviewed. A cross-case synthesis was used for analysis. Results Of 30 participants 21 received a SERM-recommendation, 11 decided to take SERMs. Counseling impacted decision-making, but did not determine it. Three categories emerged: 1.) ability to change the decision anytime, 2.) perceptions on medications, and 3.) proximity of cancer. Conclusion Decision-making under conditions of a risk diagnosis such as increased breast cancer risk is a continuous process in which risk information is transformed into practical and experiential considerations. Practice implications Individuals’ health care decision-making is only marginally dependent on the interactions in the clinic. Accepting patients’ experiences and beliefs in their own right and letting them guide the discussion may be important for a satisfying decision-making process.

Background Minority women in the U.S. continue to experience inferior breast cancer outcomes compared with white women, in part due to delays in care delivery. Emerging cancer care delivery models like patient navigation focus on social barriers, but evidence demonstrating how these models increase social capital is lacking. This pilot study describes the social networks of newly diagnosed breast cancer patients and explores the contributing role of patient navigators. Materials and methods Twenty-five women completed a one hour interview about their social networks related to cancer care support. Network metrics identified important structural attributes and influential individuals. Bivariate associations between network metrics, type of network, and whether the network included a navigator were measured. Secondary analyses explored associations between network structures and clinical outcomes. Results We identified three types of networks: kin-based, role and/or affect-based, or heterogeneous. Network metrics did not vary significantly by network type. There was a low prevalence of navigators included in the support networks (25%). Network density scores were significantly higher in those networks without a navigator. Network metrics were not predictive of clinical outcomes in multivariate models. Conclusion Patient navigators were not frequently included in support networks, but provided distinctive types of support. If navigators can identify patients with poorly integrated (less dense) social networks, or who have unmet tangible support needs, the intensity of navigation services could be tailored. Services and systems that address gaps and variations in patient social networks should be explored for their potential to reduce cancer health disparities. Implications for practice This study used a new method to identify the breadth and strength of social support following a diagnosis of breast cancer, especially examining the role of patient navigators in providing support. While navigators were only included in one quarter of patient support networks, they did provide essential supports to some individuals. Health care providers and systems need to better understand the contributions of social supports both within and outside of health care to design and tailor interventions that seek to reduce health care disparities and improve cancer outcomes.

This chapter will describe the experience from the implementation of a Patient Navigation program within the Breast Health Center at Boston University Medical Center, an academic safety net institution serving a diverse urban population in Boston, Massachusetts. We first describe the development of the program, as a means to address observed disparities in the delivery of breast health services, and then share the evolution of the program as we refined the theoretical framework and scope of Patient Navigation to meet our community needs. The final section will describe the essential lessons learned to guide best practice implementation and evaluation of Patient Navigation as a model for reducing disparities in prevention and early detection in breast cancer.

Cancer care has long been documented as an arena of racial, ethnic, and socioeconomic disparities (Freeman 1989; Koh 2009). Disparities in care delivery impact patient outcomes (Battaglia et al. 2007). One of the emerging health care delivery models designed to reduce cancer care disparities is patient navigation. Named in the early 1990s by Harold Freeman, patient navigation aims to reduce delays in care for disadvantaged populations by addressing barriers to care through one-on-one intervention (Freeman, Muth, and Kerner 1995). Since its inception, patient navigation has expanded rapidly and is now used in many settings across the cancer care continuum (Freeman 2012; Stanley et al. 2013). By 2003, over 200 navigation programs were documented (Hede 2006). The National Cancer Institute has funded patient navigation through a number of programs, including the Community Network Programs (Braun et al. 2012) and the NCI Community Cancer Centers Programs (Swanson et al. 2012), as well as individually funded grants. Three large-scale national patient navigation programs represent the largest coordinated implementation efforts to date: The American Cancer Society with 137 navigators, the Centers for Medicare and Medicaid’s Medicare Cancer Prevention and Treatment Demonstration for Racial and Ethnic Minorities (Mitchell et al. 2010), and the National Cancer Institute Patient Navigation Research Program (Freund et al. 2008). The NCI Patient Navigation Research Program recently reported results indicating navigation produced more timely diagnostic resolution following abnormal screening (Battaglia et al. 2012; Dudley et al. 2012; Hoffman et al. 2012; Markossian, Darnell, and Calhoun 2012; Paskett et al. 2012; Raich et al. 2012; Wells et al. 2012). Despite this demonstrated effectiveness, there is little systematic examination of how programs outside of these organizations are implemented (Stanley et al. 2013). Patient navigation programs have been shown to vary in terms of navigator training, services provided, outcomes measured, and efficacy (Wells et al. 2008). This is in part due to the lack of reimbursement for navigation and reliance on institutional, foundation, or research grant funding to establish and maintain programs. The Commission on Cancer has mandated that all accredited cancer centers implement patient navigation programs by 2015 (Commission on Cancer 2012) despite the somewhat limited range of systematic program evaluation conducted. Given the rapid diffusion of patient navigation as an intervention to reduce cancer outcome disparities, there is an identified need to clarify the scope of navigation and ascertain commonalities to develop comparative evaluations (Esparza and Calhoun 2011). A unifying definition of patient navigation has been hindered by the lack of a process to come to consensus around the definition of navigation while allowing for variation in local implementation. One existing model for measuring the implementation of patient navigation programs is a nine-principle framework developed by Harold Freeman and colleagues during a 2010 summit on the measurement of patient navigation (Freeman and Rodriguez 2011). The model suggests a set of consensus characteristics without explicitly addressing variations in local context. This framework was not presented with data from existing programs to assess how well it reflects the organization and function of navigation programs. Thus, this exploratory study aims to evaluate how closely these principles reflect the practice of navigation in self-identified breast cancer patient navigation programs through independent observation of routine navigator activities.

Patient navigation (PN) is a system-level strategy to decrease cancer mortality rates by reducing barriers to cancer care. Barriers to resolution among participants in the PN intervention arm with a breast or cervical abnormality in the Patient Navigation Research Program and navigators' actions to address those barriers were examined.Data from seven institutions (2005-2010) included 1,995 breast and 1,194 cervical patients. A stratified Cox proportional hazards regression model was used to examine the effects of barriers on time to resolution of an abnormal screening test or clinical finding.The range of unique barriers was 0 to 12 and 0 to 7 among participants with breast and cervical abnormalities, respectively. About two thirds of breast and one half of cervical participants had at least one barrier resulting in longer time to diagnostic resolution among breast (adjusted hazard ratio [HR], 0.744; p .001) and cervical (adjusted HR, 0.792; p .001) participants. Patient- and system-level barriers were most common. Frequent navigator actions were making arrangements, scheduling appointments, referrals, and education.Having a barrier resulted in a delay in diagnostic resolution of an abnormal screening test or clinical finding. Health care systems can use these findings to improve existing PN programs or when developing new programs.

BACKGROUND Navigators can facilitate timely access to cancer services, but to the authors' knowledge there are little data available regarding their economic impact. METHODS The authors conducted a cost-consequence analysis of navigation versus usual care among 10,521 individuals with abnormal breast, cervical, colorectal, or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1, 2006 to March 31, 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multilevel, mixed-effects regression modeling adjusting for age, race/ethnicity, language, marital status, insurance status, cancer, and site clustering. RESULTS The majority of individuals were members of a minority (70.7%) and uninsured or publically insured (72.7%). Diagnostic resolution was higher for navigation versus usual care at 180 days (56.2% vs 53.8%; P = .008) and 270 days (70.0% vs 68.2%; P

Inequity in cancer outcomes for minorities and vulnerable populations has been linked to delays in cancer care that arise from barriers to accessing care. Social service barriers represent those obstacles related to meeting life's most basic needs, like housing and income, which are often supported by public policy, regulation and services.To examine the association between social service barriers and timely diagnostic resolution after a cancer screening abnormality.Secondary analysis of the intervention arm of Boston Patient Navigation Research Program (2007-2008) conducted across six urban community health centers. Subjects with no barriers, other barriers, and social service barriers were compared on their time to diagnostic resolution.Women ≥ 18 years of age with a breast or cervical cancer screening abnormality.Social service barriers included: income supports, housing and utilities, education and employment, and personal/family stability and safety. Time to event analyses compared across five groups: those with no barriers, one barrier (other), one barrier (social service), two or more barriers (all other), and two or more barriers (at least one social service).1,481 navigated women; 31 % Hispanic, 27 % Black, 32 % White; 37 % non-English speakers and 28 % had private health insurance. Eighty-eight women (6 %) had social service barriers. Compared to those without social service barriers, those with were more likely to be Hispanic, younger, have public/no health insurance, and have multiple barriers. Those with two or more barriers (at least one social service barrier), had the longest time to resolution compared to the other four groups (aHR resolution60 days = 0.27, ≥ 60 days = 0.37).Vulnerable women with multiple barriers, when at least one is a social service barrier, have delays in care despite navigation. The impact of patient navigation may never be fully realized if social service barriers persist without being identified or addressed.

Life expectancy for US women lags behind that for women in other countries. Factors contributing to inequitable health for women are complex and include policy, community, healthcare access, and the interaction between the patient and her healthcare provider working within the healthcare system. We propose a societal pyramid of health accounting for the effects of these different factors and their impact on prevention, screening, diagnosis, and management of disease using the examples of smoking and obesity, two of the most important yet modifiable risk factors for chronic disease and death among US women.美国女性的平均寿命低于其它国家女性。造成这种不公平女性健康状况的因素很复杂，其中包括政策、社区、医疗护理获取途径以及患者与其在医疗护理系统中工作的医疗护理提供者之间的互动。我们提出了一个社会健康金字塔模型，通过列举吸烟和肥胖这两个导致美国女性罹患慢性疾病和死亡的最重要但可改变的风险因素，说明了该等差异因素的效应以及它们对疾病预防、筛选、诊断及管理的影响。La esperanza de vida de las mujeres de los Estados Unidos va por detrás de la de las mujeres de otros países. Los factores que contribuyen a las desigualdades en la salud de las mujeres son complejos e incluyen la política, la comunidad, el acceso a la atención médica y la interacción entre la paciente y su médico que trabaja dentro del sistema sanitario. Proponemos una pirámide social de la salud que dé cuenta de los efectos de esos distintos factores y de su impacto sobre la prevención, detección, diagnóstico y tratamiento de la enfermedad utilizando los ejemplos del tabaquismo y la obesidad, dos de los factores de riesgo más importantes, aunque modificables, de enfermedad crónica y muerte entre las mujeres estadounidenses.

Shared decision making (SDM) related to test preference has been advocated as a potentially effective strategy for increasing adherence to colorectal cancer (CRC) screening, yet primary care providers (PCPs) are often reluctant to comply with patient preferences if they differ from their own. Risk stratification advanced colorectal neoplasia (ACN) provides a rational strategy for reconciling these differences.To assess the importance of risk stratification in PCP decision making related to test preference for average-risk patients and receptivity to use of an electronic risk assessment tool for ACN to facilitate SDM.Mixed methods, including qualitative key informant interviews and a cross-sectional survey.PCPs at an urban, academic safety-net institution.Screening preferences, factors influencing patient recommendations and receptivity to use of a risk stratification tool.Nine PCPs participated in interviews and 57 completed the survey. Despite an overwhelming preference for colonoscopy by 95% of respondents, patient risk (67%) and patient preferences (63%) were more influential in their decision making than patient comorbidities (31%; P0.001). Age was the single most influential risk factor (excluding family history), with20% of respondents choosing factors other than age. Most respondents reported that they would be likely to use a risk stratification tool in their practice either 'often' (43%) or sometimes (53%).Risk stratification was perceived to be important in clinical decision making, yet few providers considered risk factors other than age for average-risk patients. Providers were receptive to the use of a risk assessment tool for ACN when recommending an appropriate screening test for select patients.

Background: Residents of public housing have poorer health indicators than comparably resourced individuals from the larger community. Objectives: To identify major health concerns, issues, and barriers to health of community members living in public housing developments, especially as related to cardiovascular disease prevention. To identify similarities and differences between data collected using two methods to inform future health promotion programs and policies. Methods: Key informant interviews were conducted with resident leaders and analyzed qualitatively in eight housing developments. Results were compared with quantitative data collected from a resident health survey with a large sample that analyzed individual and development-level characteristics, major health concerns, and barriers. Results: Several development-level characteristics were significantly associated with residents’ health concerns and barriers, including development size, percentage of Spanish speakers, and presence of a tenant task force (TTF); important health promotion barriers included lack of resident engagement, inconsistency in programming, lack of knowledge of actions to prevent chronic disease, and lack of resources for health promotion. Safety-related health concerns were named as a priority. Conclusions: Multiple data collection methods can yield important data about community health priorities and barriers; areas of difference and similarity between methods are especially useful in guiding health promotion efforts and opportunities.

Patient navigation is emerging as a standard in breast cancer care delivery, yet multi-site data on the impact of navigation at reducing delays along the continuum of care are lacking. The purpose of this study was to determine the effect of navigation on reaching diagnostic resolution at specific time points after an abnormal breast cancer screening test among a national sample. A prospective meta-analysis estimated the adjusted odds of achieving timely diagnostic resolution at 60, 180, and 365 days. Exploratory analyses were conducted on the pooled sample to identify which groups had the most benefit from navigation. Clinics from six medical centers serving vulnerable populations participated in the Patient Navigation Research Program. Women with an abnormal breast cancer screening test between 2007 and 2009 were included and received the patient navigation intervention or usual care. Patient navigators worked with patients and their care providers to address patient-specific barriers to care to prevent delays in diagnosis. A total of 4675 participants included predominantly racial/ethnic minorities (74 %) with public insurance (40 %) or no insurance (31 %). At 60 days and 180 days, there was no statistically significant effect of navigation on achieving timely diagnostic care, but a benefit of navigation was seen at 365 days (aOR 2.12, CI 1.36-3.29). We found an equal benefit of navigation across all groups, regardless of race/ethnicity, language, insurance status, and type of screening abnormality. Patient navigation resulted in more timely diagnostic resolution at 365 days among a diverse group of minority, low-income women with breast cancer screening abnormalities. Trial registrations clinicaltrials.gov Identifiers: NCT00613275, NCT00496678, NCT00375024, NCT01569672.

Learning Objectives After completing this course, the reader will be able to: Describe the role and potential benefits of patient navigation in breast cancer care.Explain disparities in breast cancer care and their impact on patient populations. CME This article is available for continuing medical education credit at CME.TheOncologist.com The elimination of cancer disparities is critically important for lessening the burden of breast cancer (BC). Patient navigator programs (PNPs) have been shown to improve rates of BC screening in underserved communities, but there is a dearth of evidence regarding their benefits after the actual diagnosis of BC. We retrospectively examined sociodemographic characteristics, disease characteristics, and concordance to quality measures (QMs) of BC care among women participating in a PNP that services disadvantaged minority communities in the greater Boston area. Of the 186 PNP patients diagnosed with BC in 2001–2011 in three neighborhood community health centers, treatment data was available for 158 (85%) and race and disease stage information was available for 149 (80%). Regarding stage, 25% were diagnosed with in situ cancer, 32% had stage 1, 25% had stage 2, 13% had stage 3, and 5% had stage 4 BC. Guideline-indicated care was received by 70 of 74 patients (95%) for the hormonal therapy QM, 15 of 17 (88%) patients for the chemotherapy QM, and 65 of 71 (92%) patients for the radiation QM, all similar to published concordance rates at elite National Comprehensive Cancer Network institutions. These findings suggest that PNPs may facilitate evidence-based quality care for vulnerable populations. Future research should prospectively analyze quality metrics to assess measures to improve the process and outcomes of patient navigation in diverse underserved settings, compared with control non-navigated populations.

With the increases in complexity of care for breast health concerns, there is a growing need for efficient and effective clinical evaluation, especially for vulnerable populations at risk for poor outcomes. The Breast Health Center at Boston Medical Center is a multidisciplinary program, with internists providing care alongside breast surgeons, radiologists, and patient navigators. Using a triage system previously shown to have high provider and patient satisfaction, and the ability to provide timely care, patients are assigned to either a breast surgeon or internist. From 2007 to 2009, internists cared for 2,408 women, representing half of all referrals. Women served were diverse in terms of race (33% black, 30% Hispanic, 5% Asian), language (34% require language interpreter), and insurance status (51% had no insurance or public insurance). Most presented with an abnormal screen (breast examination 54% or imaging 4%) while the remainder were seen for symptoms such as pain (26%), non-bloody nipple discharge (4%), or risk assessment (7%). A majority of final diagnoses were made through clinical evaluation alone (n = 1,760, 73%), without the need for additional diagnostic imaging or tissue sampling; 9% (n = 214) received a benign diagnosis with the aid of breast imaging; 19% (n = 463) required tissue sampling. Only 4% went on to see a breast surgeon. Internists diagnosed 15 incident cancers with a median time to diagnosis of 19 days. Patient and provider satisfaction was high. These data suggest that a group of appropriately trained internists can provide quality breast care to a vulnerable population in a multidisciplinary setting. Replication of this model requires the availability of more clinical training programs for non-surgical providers.