Risk-management decision-making data from a community-based sample of racially diverse women at high risk of breast cancer: rationale, methods, and sample characteristics of the Daughter Sister Mother Project survey.

BACKGROUND: To understand the dynamics that limit use of risk-management options by women at high risk of breast cancer, there is a critical need for research that focuses on patient perspectives. Prior research has left important gaps: exclusion of high-risk women not in risk-related clinical care, exclusion of non-white populations, and lack of attention to the decision-making processes that underlie risk-management choices. Our objective was to create a more inclusive dataset to facilitate research to address disparities related to decision making for breast cancer risk management. METHODS: The Daughter Sister Mother Project survey collects comprehensive information about the experiences of women at high risk of breast cancer. We collected novel measures of feelings about and reactions to cancer screenings; knowledge, barriers, and facilitators of risk-management options; beliefs related to cancer risk and risk management; and involvement with loved ones who had cancer. Eligible individuals were non-Hispanic white and non-Hispanic Black adult women who self-identified as having high risk of breast cancer and had no personal history of cancer. Between October 2018 and August 2019, 1053 respondents completed the online survey. Of these, 717 were confirmed through risk prediction modeling to have a lifetime breast cancer risk of ≥ 20%. Sociodemographic characteristics of this sample were compared to those of nationally representative samples of the US population: the 2019 Health Information National Trends Survey and the Pew Research Center report: Jewish Americans in 2020. RESULTS: The sample of 717 women at objectively high risk of breast cancer was largely (95%) recruited from non-clinical sources. Of these respondents, only 31% had seen a genetic counselor, 34% had had genetic testing specific to breast cancer risk, and 35% had seen at least one breast or cancer care specialist. The sample includes 35% Black respondents and 8% with Ashkenazi Jewish ancestry. Although encompassing a substantial range of ages, incomes, and education levels, respondents are overall somewhat younger, higher-income, and more educated than the US population as a whole. CONCLUSIONS: The DSM dataset offers comprehensive data from a community-based, diverse sample of women at high risk of breast cancer. The dataset includes substantial proportions of Black and Ashkenazi Jewish women and women who are not already in clinical care related to their breast cancer risk. This sample will facilitate future studies of risk-management behaviors among women who are and are not receiving high-risk care, and of variations in risk-management experiences across race and ethnicity.

Short-term and long-term financial toxicity from breast cancer treatment: a qualitative study.

PURPOSE: The rising cost of breast cancer treatment has increased patients' financial burden, intensifying an already stressful treatment process. Although researchers increasingly recognize the harmful impact of medical and nonmedical costs associated with cancer treatment, understanding patients' perspectives of financial toxicity is limited. We aimed to explore the topic of financial toxicity through the lived experiences of patients with breast cancer from groups at risk of social and economic marginalization. METHODS: We conducted semi-structured interviews with 50 women with breast cancer from four specific groups: Black women, Medicaid enrollees, rural residents, and women age ≤ 40. We transcribed, coded, and analyzed the data using deductive and inductive approaches. RESULTS: Two overarching themes captured patients' experiences of financial toxicity: short-term and long-term impacts. Short-term stressors included direct medical (e.g., co-pays, premiums), nonmedical (e.g., transportation, lodging), and indirect (e.g., job loss, reduced work hours) costs. Early in their treatments, patients' focus on survival took precedence over financial concerns. However, as the treatment course progressed, fear of consequences from compounding costs of care and financial distress negatively impacted patients' lifestyles and outlooks for the future. CONCLUSION: Programs addressing financial toxicity that look beyond early-phase interventions are needed. Specifically, patients struggling with the accumulation of treatment costs and the resultant stress require ongoing support. Long-term support is especially needed for groups vulnerable to financial instability and social marginalization.

Turning the Page on Breast Cancer in Ohio: Lessons learned from implementing a multilevel intervention to reduce breast cancer mortality among Black women.

BACKGROUND: Turning the Page on Breast Cancer (TPBC) uses a multilevel approach to reduce breast cancer (BC) mortality among Black women. TPBC intervenes by (1) improving health care facilities' ability to conduct effective BC screening, follow-up, and treatment; (2) involving community-based organizations; and (3) providing education and personal risk information through a culturally relevant website. Ohio has among the worst BC mortality rates in the United States for Black women. TPBC is in its third year of providing targeted interventions in 12 Ohio counties with particularly high BC rates among Black women. METHODS: TPBC enrolls health care facilities, collects organizational and patient data, and conducts key informant interviews to inform the provision of appropriate evidence-based interventions. TPBC engages Black communities through community-based organizations and social media advertising. The TPBC website offers BC information, connects Black women to community BC resources, and provides access to a risk-assessment tool. RESULTS: TPBC has provided tailored information packets, evidence-based interventions, and systematic support for improving the tracking and follow-up of breast health care among patients in 10 clinical partnerships. The project has provided education at community events monthly since mid-2021. The TPBC website (http://endbreastcancerohio.org) is promoted through social media (primarily Facebook) and community events to reach Black women aged 25-70 years. To date, 4108 unique users have visited the website, of whom 15.9% completed the risk assessment. CONCLUSIONS: Novel strategies are needed to address persistent disparities in BC outcomes among Black women. TPBC demonstrates the potential effectiveness of multiple methods of community-based, clinic-based, and web-based engagement. PLAIN LANGUAGE SUMMARY: Turning the Page on Breast Cancer (TPBC) aims to reduce breast cancer mortality among Black women in Ohio by conducting multilevel, community-engaged interventions in 12 counties. Women are provided risk information and education at virtual and in-person community events and through a community-friendly website that was launched in November 2020. Almost 4000 women have visited the website, which offers community-targeted information, urges screening for individuals at elevated risk, and offers access to patient navigation services; 655 users have used a breast cancer risk-assessment tool on the site. Community-based organizations conduct educational efforts. TPBC partners with health care facilities, which are taught to improve their ability to conduct effective breast cancer screening, follow-up, and treatment. So far, TPBC has provided educational information, evidence-based intervention lists, tailored information packets, and ongoing quarterly support to partners in 10 counties. Evaluation will focus on aggregated data for screening and genetic testing referral at the clinic level.

Effect of a Telephone-Based Lifestyle Intervention on Weight, Body Composition, and Metabolic Biomarkers in Rural Ohio: Results from a Randomized Pilot Study.

Rural residents experience higher rates of obesity, obesity-related chronic diseases, and poorer lifestyle. Promoting physical activity and healthy eating are critical for rural residents; however, lack of resources and access barriers limit the feasibility of in-person lifestyle interventions. There is a need to design and deliver remotely accessible lifestyle interventions in this population. This pilot study examined the effect of a telephone-based lifestyle intervention on weight, body composition, lipids, and inflammatory biomarkers among rural Ohio residents. Rural Ohio adults with overweight/obesity (n = 40) were 2:1 randomized to a 15-week telephone-based lifestyle intervention (n = 27) or control group (n = 13). The lifestyle intervention group received weekly telephone counseling sessions emphasizing healthy eating and increasing physical activity. The control group received educational brochures describing physical activity and dietary recommendations. Weight, body composition, fasting blood lipids, and inflammatory biomarkers were objectively measured at baseline and 15 weeks at local community centers (trial registration#: NCT05040152 at ClinicalTrial.gov). Linear mixed models were used to examine change over time by group. Participants were mostly female, with an average age of 49 years. Over the 15-week trial, the lifestyle intervention showed superior improvements in total cholesterol (∆ = -18.7 ± 7.8 mg/dL, p = 0.02) and LDL (∆ = -17.1 ± 8.1 mg/dL, p = 0.04) vs. control, whereas no significant between-group differences in weight, body composition, or inflammation were observed. Our findings suggest that a 15-week telephone-based lifestyle intervention may offer metabolic benefits that reduce disease risk in rural adults with obesity. Future large-scale studies are needed to determine the efficacy of remotely accessible lifestyle interventions in rural populations, with the goal of reducing obesity-related disparities.

The relationship between family history of cancer and cancer attitudes & beliefs within the Community Initiative Towards Improving Equity and Health Status (CITIES) cohort.

OBJECTIVE: To determine the relationship between family history of cancer with cancer attitudes and beliefs (CABs) and cancer screening knowledge. METHODS: This study used data collected for the Community Initiative Towards Improving Equity and Health Status (CITIES) project which surveyed Ohioans ages 21-74. In the current analysis, we included data on age, gender, race, marital status, education, income, financial security, health insurance, CABs, knowledge about the correct age to begin cancer screenings, and presence of a first-degree relative with cancer. Multivariable logistic regression was used to examine the association of family history of cancer with CABs and knowledge about the correct age to begin cancer screening. RESULTS: Participants were predominantly over the age of 41, female, and white. Out of 603 participants, 295 (48.92%) reported not having a first-degree relative with cancer and 308 (51.08%) reported having a first-degree relative with cancer. Overall, 109 (18.08%) participants reported negative CABs, 378 (62.69%) reported moderate CABs, and 116 (19.24%) reported positive CABs. Participants who reported a first-degree relative with cancer were more likely to report positive CABs, but the association was not significant (p = .11). We observed that older, more educated, and married participants were more likely to have positive CABs (all p < 0.05). Family history of cancer was not associated with differences in knowledge about the correct age for beginning colorectal cancer screening (p = .85) and mammography (p = .88). CONCLUSIONS: Having a first-degree relative with cancer was not found to be associated with CABs or knowledge about cancer screening. However, age and socioeconomic status were associated with more positive CABs and increased knowledge about cancer screening. Future research should focus on standardizing a CABs scale and expanding the generalizability of our findings.

Quantifying structural racism in cohort studies to advance prospective evidence.

Calls-to-action in health research have described a need to improve research on race, ethnicity, and structural racism. Well-established cohort studies typically lack access to novel structural and social determinants of health (SSDOH) or precise race and ethnicity categorization, contributing to a loss of rigor to conduct informative analyses and a gap in prospective evidence on the role of structural racism in health outcomes. We propose and implement methods that prospective cohort studies can use to begin to rectify this, using the Women's Health Initiative (WHI) cohort as a case study. To do so, we evaluated the quality, precision, and representativeness of race, ethnicity, and SSDOH data compared with the target US population and operationalized methods to quantify structural determinants in cohort studies. Harmonizing racial and ethnic categorization to the current standards set by the Office of Management and Budget improved measurement precision, aligned with published recommendations, disaggregated groups, decreased missing data, and decreased participants reporting "some other race". Disaggregation revealed sub-group disparities in SSDOH, including a greater proportion of Black-Latina (35.2%) and AIAN-Latina (33.3%) WHI participants with income below the US median compared with White-Latina (42.5%) participants. We found similarities in the racial and ethnic patterning of SSDOH disparities between WHI and US women but less disparity overall in WHI. Despite higher individual-level advantage in WHI, racial disparities in neighborhood resources were similar to the US, reflecting structural racism. Median neighborhood income was comparable between Black WHI ($39,000) and US ($34,700) women. WHI SSDOH-associated outcomes may be generalizable on the basis of comparing across race and ethnicity but may quantitatively (but not qualitatively) underestimate US effect sizes. This paper takes steps towards data justice by implementing methods to make visible hidden health disparity groups and operationalizing structural-level determinants in prospective cohort studies, a first step to establishing causality in health disparities research.

Long-term Trajectories of Physical Function Decline in Women With and Without Cancer.

Importance: Patients with cancer experience acute declines in physical function, hypothesized to reflect accelerated aging driven by cancer-related symptoms and effects of cancer therapies. No study has examined long-term trajectories of physical function by cancer site, stage, or treatment compared with cancer-free controls. Objective: Examine trajectories of physical function a decade before and after cancer diagnosis among older survivors and cancer-free controls. Design, Setting, and Participants: This prospective cohort study enrolled patients from 1993 to 1998 and followed up until December 2020. The Women's Health Initiative, a diverse cohort of postmenopausal women, included 9203 incident cancers (5989 breast, 1352 colorectal, 960 endometrial, and 902 lung) matched to up to 5 controls (n = 45 358) on age/year of enrollment and study arm. Exposures: Cancer diagnosis (site, stage, and treatment) via Medicare and medical records. Main Outcomes and Measures: Trajectories of self-reported physical function (RAND Short Form 36 [RAND-36] scale; range: 0-100, higher scores indicate superior physical function) estimated from linear mixed effects models with slope changes at diagnosis and 1-year after diagnosis. Results: This study included 9203 women with cancer and 45 358 matched controls. For the women with cancer, the mean (SD) age at diagnosis was 73.0 (7.6) years. Prediagnosis, physical function declines of survivors with local cancers were similar to controls; after diagnosis, survivors experienced accelerated declines relative to controls, whose scores declined 1 to 2 points per year. Short-term declines in the year following diagnosis were most severe in women with regional disease (eg, -5.3 [95% CI, -6.4 to -4.3] points per year in regional vs -2.8 [95% CI, -3.4 to -2.3] for local breast cancer) or who received systemic therapy (eg, for local endometrial cancer, -7.9 [95% CI, -12.2 to -3.6] points per year with any chemotherapy; -3.1 [95% CI, -6.0 to -0.3] with radiation therapy alone; and -2.6 [95% CI, -4.2 to -1.0] with neither, respectively). While rates of physical function decline slowed in the later postdiagnosis period (eg, women with regional colorectal cancer declined -4.3 [95% CI, -5.9 to -2.6] points per year in the year following diagnosis vs -1.4 [95% CI, -1.7 to -1.0] points per year in the decade thereafter), survivors had estimated physical function significantly below that of age-matched controls 5 years after diagnosis. Conclusions and Relevance: In this prospective cohort study, survivors of cancer experienced accelerated declines in physical function after diagnosis, and physical function remained below that of age-matched controls even years later. Patients with cancer may benefit from supportive interventions to preserve physical functioning.

A Framework for Promoting Diversity, Equity, and Inclusion in Genetics and Genomics Research.

IMPORTANCE: Research into the genetic and genomic ("genomics") foundations of disease is central to our understanding of disease prevention, early detection, diagnostic accuracy, and therapeutic intervention. Inequitable participation in genomics research by historically excluded populations limits the ability to translate genomic knowledge to achieve health equity and ensure that findings are generalizable to diverse populations. OBSERVATIONS: We propose a novel framework for promoting diversity, equity, and inclusion in genomics research. Building on principles of community-based participatory research and collective impact frameworks, the framework can guide our understanding of the social, cultural, health system, policy, community, and individual contexts in which engagement and genomics research are being done. Our framework highlights the involvement of a multistakeholder team, including the participants and communities to be engaged, to ensure robust methods for recruitment, retention, return of genomic results, quality of engagement, follow-up, and monitoring of participants. CONCLUSIONS AND RELEVANCE: The proposed engagement framework will guide investigators in optimizing equitable representation in research and enhancing the rigor of genomics investigation.

Taking action to advance the study of race and ethnicity: the Women's Health Initiative (WHI).

"Race" and "ethnicity" are socially constructed terms, not based on biology - in contrast to biologic ancestry and genetic admixture - and are flexible, contested, and unstable concepts, often driven by power. Although individuals may self-identify with a given race and ethnic group, as multidimensional beings exposed to differential life influencing factors that contribute to disease risk, additional social determinants of health (SDOH) should be explored to understand the relationship of race or ethnicity to health. Potential health effects of structural racism, defined as "the structures, policies, practices, and norms resulting in differential access to goods, services, and opportunities of society by "race," have been largely ignored in medical research. The Women's Health Initiative (WHI) was expected to enroll a racially and ethnically diverse cohort of older women at 40 U.S. clinical centers between 1993 and 1998; yet, key information on the racial and ethnic make-up of the WHI cohort of 161,808 women was limited until a 2020-2021 Task Force was charged by the WHI Steering Committee to better characterize the WHI cohort and develop recommendations for WHI investigators who want to include "race" and/or "ethnicity" in papers and presentations. As the lessons learned are of relevance to most cohorts, the essence of the WHI Race and Ethnicity Language and Data Interpretation Guide is presented in this paper. Recommendations from the WHI Race and Ethnicity Language and Data Interpretation Guide include: Studies should be designed to include all populations and researchers should actively, purposefully and with cultural-relevance, commit to recruiting a diverse sample; Researchers should collect robust data on race, ethnicity and SDOH variables that may intersect with participant identities, such as immigration status, country of origin, acculturation, current residence and neighborhood, religion; Authors should use appropriate terminology, based on a participant's self-identified "race" and "ethnicity", and provide clear rationale, including a conceptual framework, for including race and ethnicity in the analytic plan; Researchers should employ appropriate analytical methods, including mixed-methods, to study the relationship of these sociocultural variables to health; Authors should address how representative study participants are of the population to which results might apply, such as by age, race and ethnicity.

Racial differences in survival and response to therapy in patients with metastatic colorectal cancer: A secondary analysis of CALGB/SWOG 80405 (Alliance A151931).

BACKGROUND: The objective of this study was to evaluate the association between self-identified race and overall survival (OS), progression-free survival (PFS), and response to therapy among patients enrolled in the randomized Cancer and Leukemia Group B (CALGB)/SWOG 80405 trial. METHODS: Patients with advanced or metastatic colorectal cancer who were enrolled in the CALGB/SWOG 80405 trial were identified by race. On the basis of covariates (treatment arm, KRAS status, sex, age, and body mass index), each Black patient was exact matched with a White patient. The association between race and OS and PFS was examined using a marginal Cox proportional hazard model for matched pairs. The interaction between KRAS status and race was tested in the model. The association between race and response to therapy and adverse events were examined using a marginal logistic regression model. RESULTS: In total, 392 patients were matched and included in the final data set. No difference in OS (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.73-1.16), PFS (HR, 0.97; 95% CI, 0.78-1.20), or response to therapy (odds ratio [OR], 1.00; 95% CI, 0.65-1.52) was observed between Black and White patients. Patients with KRAS mutant status (HR, 1.31; 95% CI, 1.02-1.67), a performance statusscore of 1 (reference, a performance status of 0; HR, 1.49; 95% CI, 1.18-1.88), or ≥3 metastatic sites (reference, 1 metastatic site; HR, 1.67; 95% CI, 1.22-2.28) experienced worse OS. Black patients experienced lower rates and risk of grade ≥3 fatigue (6.6% vs 13.3%; OR, 0.46; 95% CI, 0.24-0.91) but were equally likely to be treated with a dose reduction (OR, 1.09; 95% CI, 0.72-1.65). CONCLUSIONS: No difference in OS, PFS, or response to therapy was observed between Black patients and White patients in an equal treatment setting of the CALGB/SWOG 80405 randomized controlled trial. LAY SUMMARY: Despite improvements in screening and treatment, studies have demonstrated worse outcomes in Black patients with colorectal cancer. The purpose of this study was to determine whether there was a difference in cancer-specific outcomes among Black and White patients receiving equivalent treatment on the CALGB/SWOG 80405 randomized clinical trial. In this study, there was no difference in overall survival, progression-free survival, or response to therapy between Black and White patients treated on a clinical trial. These findings suggest that access to care and differences in treatment may be responsible for racial disparities in colorectal cancer.

Closing the Rural Cancer Care Gap: Three Institutional Approaches.

Patients in rural areas face limited access to medical and oncology providers, long travel times, and low recruitment to clinical trials, all of which affect quality of care and health outcomes. Rural counties also have high rates of cancer-related mortality and other negative treatment outcomes. On April 10, 2019, ASCO hosted Closing the Rural Cancer Care Gap, the second event in its State of Cancer Care in America series. The event focused on two aspects of rural cancer care: a review of the major issues and concerns in delivering rural cancer care and a discussion of creative solutions to address rural-nonrural disparities. This article draws from the event and supporting literature to summarize the challenges to delivering high-quality care in rural communities, update ASCO's workforce data on the geographic distribution of oncologists, and highlight 3 institutional approaches to addressing these challenges in diverse rural settings. The experience of the 3 institutions featured in the article suggests that increasing rural patients' access to care requires expanding services and decreasing travel distances, mitigating financial burdens when insurance coverage is limited, opening avenues to clinical trial participation, and creating partnerships between providers and community leaders to address local gaps in care. Because the characteristics of rural communities, health care resources, and patient populations are not homogeneous, rural health disparities require local solutions that are based on community needs, available resources, and trusting and collaborative partnerships.

Prevalence and correlates of job and insurance problems among young breast cancer survivors within 18 months of diagnosis.

BACKGROUND: The prevalence and correlates of job and insurance problems were examined among a cohort of young U.S. breast cancer survivors during the first 18-months following diagnosis. METHODS: Participants were 708 women diagnosed at ≤45 years with stage I-III breast cancer. 90% were non-Hispanic white, 76% were married/partnered and 67% had ≥4-year college degree. Univariable and multivariable logistic regression examined the associations between demographic, lifestyle and clinical factors with job and insurance problems. RESULTS: 18-months after diagnosis, 56% of participants worked full-time, 16% part-time, 18% were homemakers and/or students, 4.5% were unemployed, and 2.4% were disabled. The majority (86%) had private insurance. Job-related problems were reported by 40% of women, and included believing they could not change jobs for fear of losing health insurance (35.0%), being fired (2.3%), and being demoted, denied promotion or denied wage increases (7.8%). Greater job-related problems were associated with being overweight vs. under/normal weight (p = 0.006), income <$50,000/per year (p = 0.01), and working full-time vs. part-time (p = 0.003). Insurance problems were reported by 27% of women, and included being denied health insurance (2.6%), health insurance increases (4.3%), being denied health benefit payments (14.8%) or denied life insurance (11.4%). Insurance problems were associated with being under/normal weight vs. obese (p = 0.01), not being on hormone therapy (p < 0.001), and a tumor size > 5 cm vs. < 2 cm (p = 0.01). CONCLUSIONS: Young survivors experienced significant job- and insurance-related issues following diagnosis. To the extent possible, work and insurance concerns should be addressed prior to treatment to inform work expectations and avoid unnecessary insurance difficulties.

Breast cancer early detection: A phased approach to implementation.

When breast cancer is detected and treated early, the chances of survival are very high. However, women in many settings face complex barriers to early detection, including social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast health care services. Previously, the Breast Health Global Initiative (BHGI) developed resource-stratified guidelines for the early detection and diagnosis of breast cancer. In this consensus article from the sixth BHGI Global Summit held in October 2018, the authors describe phases of early detection program development, beginning with management strategies required for the diagnosis of clinically detectable disease based on awareness education and technical training, history and physical examination, and accurate tissue diagnosis. The core issues address include finance and governance, which pertain to successful planning, implementation, and the iterative process of program improvement and are needed for a breast cancer early detection program to succeed in any resource setting. Examples are presented of implementation, process, and clinical outcome metrics that assist in program implementation monitoring. Country case examples are presented to highlight the challenges and opportunities of implementing successful breast cancer early detection programs, and the complex interplay of barriers and facilitators to achieving early detection for breast cancer in real-world settings are considered.

A Multi-level Model to Understand Cervical Cancer Disparities in Appalachia.

The Appalachian region experiences higher incidence and mortality due to cervical cancer compared with other regions of the United States. The goal of the Ohio State University Center for Population Health and Health Disparities (CPHHD), called the Community Awareness Resources and Education (CARE) project, was to understand reasons for this disparity. The first wave (2003-2008) of funding included three projects focusing on the known risk factors for cervical cancer, lack of screening, smoking, and infection with human papillomavirus (HPV). On the basis of the results of these projects, the second wave (2011-2017) included four projects, designed to address a multi-level model of factors contributing to cervical disparities in Appalachia. The results of these projects were then used to refine a multi-level model that explains cervical cancer disparities in Appalachia. Future funded projects will take these multi-level explanations for cervical disparities and focus on implementation science strategies to reduce the burden of cervical cancer morbidity and mortality in Appalachia.See all articles in this Special Collection Honoring Paul F. Engstrom, MD, Champion of Cancer Prevention.

Reporting of Cardiovascular Events in Clinical Trials Supporting FDA Approval of Contemporary Cancer Therapies.

BACKGROUND: Cardiovascular disease (CVD) has become an increasingly common limitation to effective anticancer therapy. Yet, whether CVD events were consistently reported in pivotal trials supporting contemporary anticancer drugs is unknown. OBJECTIVES: The authors sought to evaluate the incidence, consistency, and nature of CVD event reporting in cancer drug trials. METHODS: From the Drugs@FDA, clinicaltrials.gov, MEDLINE, and publicly available U.S. Food and Drug Administration (FDA) drug reviews, all reported CVD events across latter-phase (II and III) trials supporting FDA approval of anticancer drugs from 1998 to 2018 were evaluated. The primary outcome was the report of major adverse cardiovascular events (MACE), defined as incident myocardial infarction, stroke, heart failure, coronary revascularization, atrial fibrillation, or CVD death, irrespective of treatment arm. The secondary outcome was report of any CVD event. Pooled reported annualized incidence rates of MACE in those without baseline CVD were compared with reported large contemporary population rates using relative risks. Population risk differences for MACE were estimated. Differences in drug efficacy using pooled binary endpoint hazard ratios on the basis of the presence or absence of reported CVD were also assessed. RESULTS: Overall, there were 189 trials, evaluating 123 drugs, enrolling 97,365 participants (58.5 ± 5 years, 46.0% female, 72.5% on biologic, targeted, or immune-based therapies) with 148,138 person-years of follow-up. Over a median follow-up of 30 months, 1,148 incidents of MACE (375 heart failure, 253 myocardial infarction, 180 strokes, 65 atrial fibrillation, 29 revascularizations, and 246 CVD deaths; 792 in the intervention vs. 356 in the control arm; p < 0.01) were reported from the 62.4% of trials noting any CVD. The overall weighted-average incidence was 542 events per 100,000 person-years (716 per 100,000 in the intervention arm), compared with 1,408 among similar-aged non-cancer trial subjects (relative risk: 0.38; p < 0.01), translating into a risk difference of 866. There was no association between reporting CVD events and drug efficacy (hazard ratio: 0.68 vs. 0.67; p = 0.22). CONCLUSIONS: Among pivotal clinical trials linked to contemporary FDA-approved cancer drugs, reported CVD event rates trail expected population rates.

Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial.

BACKGROUND: First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only. METHODS: Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN. RESULTS: At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms (P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28). CONCLUSIONS: Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately. IMPACT: These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.

Cost-Effectiveness of Community-Based Tobacco Dependence Treatment Interventions: Initial Findings of a Systematic Review.

INTRODUCTION: Scientific literature evaluating the cost-effectiveness of tobacco dependence treatment programs delivered in community-based settings is scant, which limits evidence-based tobacco control decisions. The aim of this review was to systematically assess the cost-effectiveness and quality of the economic evaluations of community-based tobacco dependence treatment interventions conducted as randomized controlled trials in the United States. METHODS: We searched 8 electronic databases and gray literature from their beginning to February 2018. Inclusion criteria were economic evaluations of community-based tobacco dependence treatments conducted as randomized controlled trials in the United States. Two independent researchers extracted data on study design and outcomes. Study quality was assessed by using Drummond and Jefferson's economic evaluations checklist. Nine of 3,840 publications were eligible for inclusion. Heterogeneity precluded formal meta-analyses. We synthesized a qualitative narrative of outcomes. RESULTS: All 9 studies used cost-effectiveness analysis and a payer/provider/program perspective, but several study components, such as abstinence measures, were heterogeneous. Study participants were predominantly English speaking, middle aged, white, motivated to quit, and highly nicotine dependent. Overall, the economic evaluations met most of Drummond and Jefferson's recommendations; however, some studies provided limited details. All studies had a cost per quit at or below $2,040 or an incremental cost-effectiveness ratio (ICER) at or below $3,781. When we considered biochemical verification, sensitivity analysis, and subgroups, the costs per quit were less than $2,050 or the ICERs were less than $6,800. CONCLUSION: All community-based interventions included in this review were cost-effective. When economic evaluation results are extrapolated to future savings, the low cost per quit or ICER indicates that the cost-effectiveness of community-based tobacco dependence treatments is similar to the cost-effectiveness of clinic-based programs and that community-based interventions are a valuable approach to tobacco control. Additional research that more fully characterizes the cost-effectiveness of community-based tobacco dependence treatments is needed to inform future decisions in tobacco control policy.

Overcoming Barriers to Sustaining Health Equity Interventions: Insights from the National Institutes of Health Centers for Population Health and Health Disparities.

We conducted qualitative semi-structured telephone interviews with the directors of the 10 National Institutes of Health Centers for Population Health and Health Disparities (NIH/CPHHD) to identify factors that were associated with the sustainability of 19 interventions developed to address cancer disparities and 17 interventions developed to address cardiovascular disease disparities in the United States. Interview transcripts were analyzed using the constant comparative method of analysis to identify key themes and synthesize findings. Directors at NIH/CPHHD reported that barriers to sustainability included uncertainty about future funding and insufficient resources to build and maintain diverse stakeholder partnerships. Strategies that helped to overcome these barriers included developing and engaging community partnerships with health care systems; early pursuit of multiple funding sources; and investments in infrastructure to address the social determinants of health. Sustainability planning should be incorporated during the early stages of intervention development to facilitate maintenance of successful programs that address health disparities.

Overcoming Barriers to Clinical Trial Enrollment.

Clinical trials are imperative for testing novel cancer therapies, advancing the science of cancer care, and determining the best treatment strategies to enhance outcomes for patients with cancer. However, barriers to clinical trial enrollment contribute to low participation in cancer clinical trials. Many factors play a role in the persistently low rates of trial participation, including financial barriers, logistical concerns, and the lack of resources for patients and clinicians to support clinical trial enrollment and retention. Furthermore, restrictive eligibility criteria often result in the exclusion of certain patient populations, which thus adds to the widening disparities seen between patients who enroll in trials and those treated in routine practice. Moreover, additional factors, such as difficulty by patients and clinicians in coping with the uncertainty inherent to clinical trial participation, contribute to low trial enrollment and represent key components of the decision-making process. Specifically, patients and clinicians may struggle to assess the risk-benefit ratio and may incorrectly estimate the probability and severity of challenges associated with clinical trial participation, thus complicating the informed consent process. Importantly, research has increasingly focused on overcoming barriers to clinical trial enrollment. A promising solution involves the use of patient navigators to help enhance clinical trial recruitment, enrollment, and retention. Although clinical trials are essential for improving and prolonging the lives of patients with cancer, barriers exist that can impede trial enrollment; yet, efforts to recognize and address these barriers and enhance trial enrollment are being investigated.