Project description:PurposeTo increase access of underserved/health disparities communities to National Cancer Institute (NCI) clinical trials, the Radiation Research Program piloted a unique model - the Cancer Disparities Research Partnership (CDRP) program. CDRP targeted community hospitals with a limited past NCI funding history and provided funding to establish the infrastructure for their clinical research program.MethodsInitially, 5-year planning phase funding was awarded to six CDRP institutions through a cooperative agreement (U56). Five were subsequently eligible to compete for 5-year implementation phase (U54) funding and three received a second award. Additionally, the NCI Center to Reduce Cancer Health Disparities supported their U56 patient navigation programs.ResultsCommunity-based hospitals with little or no clinical trials experience required at least a year to develop the infrastructure and establish community outreach/education and patient navigation programs before accrual to clinical trials could begin. Once established, CDRP sites increased their yearly patient accrual mainly to NCI-sponsored cooperative group trials (~60%) and Principal Investigator/mentor-initiated trials (~30%). The total number of patients accrued on all types of trials was 2,371, while 5,147 patients received navigation services.ConclusionDespite a historical gap in participation in clinical cancer research, underserved communities are willing/eager to participate. Since a limited number of cooperative group trials address locally advanced diseases seen in health disparities populations; this shortcoming needs to be rectified. Sustainability for these programs remains a challenge. Addressing these gaps through research and public health mechanisms may have an important impact on their health, scientific progress, and efforts to increase diversity in NCI clinical trials.
Project description:The development of individualized therapies has become the focus of current oncology research. Precision medicine has demonstrated great potential for bringing safe and effective drugs to those patients stricken with cancer, and is becoming a reality as more oncogenic drivers of malignancy are discovered. The discovery of Epidermal Growth Factor Receptor (EGFR) mutations as a driving mutation in non-small cell lung cancer (NSCLC) and the subsequent success of the tyrosine kinase inhibitors (TKI) have led the way for NSCLC to be at the forefront of biomarker-based drug development. However, this direction was not always so clear, and this article describes the lessons learned in targeted therapy development from EGFR in NSCLC.
Project description:Lung cancer is the leading cause of cancer mortality in the United States. Certain groups are at increased risk of developing lung cancer and experience greater morbidity and mortality than the general population. Lung cancer screening provides an opportunity to detect lung cancer at an early stage when surgical intervention can be curative; however, current screening guidelines may overlook vulnerable populations with disproportionate lung cancer burden. This review aims to characterize disparities in lung cancer screening eligibility, as well as access to lung cancer screening, focusing on underrepresented racial/ethnic minorities and high-risk populations, such as individuals with human immunodeficiency virus. We also explore potential system- and patient-level barriers that may influence smoking patterns and healthcare access. Improving access to high-quality health care with a focus on smoking cessation is essential to reduce the burden of lung cancer experienced by vulnerable populations.
Project description:Offering smoking cessation treatment at lung cancer screening (LCS) will maximize mortality reduction associated with screening, but predictors of treatment engagement are not well understood. We examined participant characteristics of engagement in an NCI SCALE cessation trial. Eligible LCS patients (N = 818) were randomized to the Intensive arm (8 phone counseling sessions +8 weeks of nicotine replacement therapy (NRT)) vs. Minimal arm (3 sessions + 2 weeks of NRT). Engagement was measured by number of sessions completed (none, some, or all) and NRT mailed (none vs. any) in each arm. In the Intensive arm, those with ≥some college (OR = 2.1, 95% CI = 1.1, 4.0) and undergoing an annual scan (OR = 2.1, 95% CI = 1.1, 4.2) engaged in some counseling vs. none. Individuals with higher nicotine dependence were more likely (OR = 2.8, 95% CI = 1.3, 6.2) to request NRT. In the Minimal arm, those with higher education (OR = 2.1, 95% CI = 1.1, 3.9) and undergoing an annual scan (OR = 2.0, 95% CI = 1.04, 3.8) completed some sessions vs. none. Requesting NRT was associated with more pack-years (OR = 1.9, 95% CI = 1.1, 3.5). Regardless of treatment intensity, additional strategies are needed to engage those with lower education, less intensive smoking histories, and undergoing a first scan. These efforts will be important given the broader 2021 LCS guidelines.
Project description:Introduction The purpose of this article is to present the collective experiences of six federally-funded critical congenital heart disease (CCHD) newborn screening implementation projects to assist federal and state policy makers and public health to implement CCHD screening. Methods A qualitative assessment and summary from six demonstration project grantees and other state representatives involved in the implementation of CCHD screening programs are presented in the following areas: legislation, provider and family education, screening algorithms and interpretation, data collection and quality improvement, telemedicine, home and rural births, and neonatal intensive care unit populations. Results The most common challenges to implementation include: lack of uniform legislative and statutory mandates for screening programs, lack of funding/resources, difficulty in screening algorithm interpretation, limited availability of pediatric echocardiography, and integrating data collection and reporting with existing newborn screening systems. Identified solutions include: programs should consider integrating third party insurers and other partners early in the legislative/statutory process; development of visual tools and language modification to assist in the interpretation of algorithms, training programs for adult sonographers to perform neonatal echocardiography, building upon existing newborn screening systems, and using automated data transfer mechanisms. Discussion Continued and expanded surveillance, research, prevention and education efforts are needed to inform screening programs, with an aim to reduce morbidity, mortality and other adverse consequences for individuals and families affected by CCHD.
Project description:Newborn screening for critical congenital heart defects (CCHD) was added to the US Recommended Uniform Screening Panel in 2011. Within 4 years, 46 states and the District of Columbia had adopted it into their newborn screening program, leading to CCHD screening being nearly universal in the United States. This rapid adoption occurred while there were still questions about the effectiveness of the recommended screening protocol and barriers to follow-up for infants with a positive screen. In response, the Centers for Disease Control and Prevention partnered with the American Academy of Pediatrics to convene an expert panel between January and September 2015 representing a broad array of primary care, neonatology, pediatric cardiology, nursing, midwifery, public health, and advocacy communities. The panel's goal was to review current practices in newborn screening for CCHD and to identify opportunities for improvement. In this article, we describe the experience of CCHD screening in the United States with regard to: (1) identifying the target lesions for CCHD screening; (2) optimizing the algorithm for screening; (3) determining state-level challenges to implementation and surveillance of CCHD; (4) educating all stakeholders; (5) performing screening using the proper equipment and in a cost-effective manner; and (6) implementing screening in special settings such as the NICU, out-of-hospital settings, and areas of high altitude.
Project description:In this review, we address selected areas that are central to the state-of-the-art of cancer prevention science. The emphasis on prevention as a viable and critical approach to decreasing cancer mortality has gained traction in recent years, evidenced by its inclusion in the US Vice President's Cancer Initiative (also termed 'Moonshot'). Cancer prevention occurs by arresting, slowing down, or reversing the carcinogenic process before invasion into surrounding tissue or by avoiding or blocking causative exposure. An important challenge is to identify individuals who will benefit most from preventive interventions with the least possible harm. Preventive interventions range from avoiding known carcinogens (e.g., tobacco or asbestos) to intervening with anticarcinogenic strategies (behavioral modifications , such as diet and exercise; medications; nutritional agents; and vaccination against causative agents). Here, we focus on active intervention with measures involving pharmaceutical and immunological agents.
Project description:BackgroundCurrent US Preventive Services Task Force (USPSTF) lung cancer screening guidelines are based on smoking history and age (55-80 years). These guidelines may miss those at higher risk, even at lower exposures of smoking or younger ages, because of other risk factors such as race, family history, or comorbidity. In this study, we characterized the demographic and clinical profiles of those selected by risk-based screening criteria but were missed by USPSTF guidelines in younger (50-54 years) and older (71-80 years) age groups.MethodsWe used data from the National Health Interview Survey, the CISNET Smoking History Generator, and results of logistic prediction models to simulate lifetime lung cancer risk-factor data for 100 000 individuals in the 1950-1960 birth cohorts. We calculated age-specific 6-year lung cancer risk for each individual from ages 50 to 90 years using the PLCOm2012 model and evaluated age-specific screening eligibility by USPSTF guidelines and by risk-based criteria (varying thresholds between 1.3% and 2.5%).ResultsIn the 1950 birth cohort, 5.4% would have been ineligible for screening by USPSTF criteria in their younger ages but eligible based on risk-based criteria. Similarly, 10.4% of the cohort would be ineligible for screening by USPSTF in older ages. Notably, high proportions of blacks were ineligible for screening by USPSTF criteria at younger (15.6%) and older (14.2%) ages, which were statistically significantly greater than those of whites (4.8% and 10.8%, respectively; P < .001). Similar results were observed with other risk thresholds and for the 1960 cohort.ConclusionsFurther consideration is needed to incorporate comprehensive risk factors, including race and ethnicity, into lung cancer screening to reduce potential racial disparities.
Project description:ObjectiveLow dose computed tomography (LDCT) became the standard method for lung cancer (LC) screening in 2013. However, it is unclear whether there are differences in survival rates based on sex and whether the differences depend on screening status. We aimed to evaluate the LC survival rates between females and males based on screening.Material and methodsThis retrospective cohort study examined data from the Boston LC Study (BLCS) between 2013 and 2021. LC screening depends on patients' demographics (age and smoking history) to determine whether a person is a high-risk individual and, therefore, undergo LDCT. Descriptive statistics were calculated for race, age, histology, smoking history, stage, and treatment. These variables' distributions were compared between sex and screening status using t-test and chi-square, respectively. Cox proportional hazards model and Kaplan-Meier curves were used to compare survival between sex and screening. Propensity score matching was applied to account for selection bias in screening when evaluating the association between screening and stage.ResultsA total of 1,216 LC patients were identified with a screening incidence of 9.4 %, among whom 56 % were female. Unscreened males had 1.59 times higher risk of mortality than unscreened females (P=.0002) and had a worse 5-year survival (male 50 %; 95 %CI, 0.38,0.6 vs female 70 %; 95 %CI,0.62,0.76). In contrast, there were no significant differences in survival between sexes among screened. In a balanced cohort of screened and unscreened, the odds of being diagnosed at late stages for females and smokers were 1.33 and 2.51 times that of males and nonsmokers; however, there were no statistical significance.ConclusionUnscreened females had a lower risk of mortality and better survival than unscreened males, while among the screened population, there was no difference in the overall survival. These observations demonstrate the influence of sex on survival prognosis in LC when screening is not performed.
Project description:TOPCAT was a multinational clinical trial of 3,445 heart failure with preserved ejection fraction (HFpEF) patients that enrolled in 233 sites in six countries in North America, Eastern Europe and South America. Patients with a heart failure hospitalization in the last 12 months or an elevated B-type natriuretic peptide (BNP) were randomized to the mineralocorticoid receptor antagonist spironolactone vs. placebo. Sites in Russia and the Republic of Georgia provided the majority of early enrollment, primarily based on the hospitalization criterion since BNP levels were initially unavailable there. With the emergence of country-specific aggregate event rate data indicating lower rates in Eastern Europe and differences in patient characteristics there, the DSMB recommended relatively increasing enrollment in North America plus other corrective measures. Although final enrollment reflected the increased contribution from North America, a plurality of the final cohort came from Russia and Georgia (49% vs. 43% in North America). BNP measurements from Russia and Georgia available later in the trial suggested no or a mild level of heart failure consistent with low event rates. The primary results showed no significant spironolactone treatment effect overall (primary endpoint hazard ratio 0.89 (0.77, 1.04)), with a significant hazard ratio in North and South America (0.82 (0.69, 0.98), p =0.026) but not in Russia and Georgia (1.10 (0.79, 1.51), interaction p = 0.12). This report describes the DSMB's detection and management recommendations for regional differences in patient characteristics in TOPCAT, and suggests methods of surveillance and corrective actions that may be useful for future trials.