Effect of Patient Navigation on Breast Cancer Screening Among African American Medicare Beneficiaries: A Randomized Controlled Trial.

BACKGROUND: There is growing evidence that patient navigation improves breast cancer screening rates; however, there are limited efficacy studies of its effect among African American older adult women. OBJECTIVE: To evaluate the effect of patient navigation on screening mammography among African American female Medicare beneficiaries in Baltimore, MD. DESIGN: The Cancer Prevention and Treatment Demonstration (CPTD), a multi-site study, was a randomized controlled trial conducted from April 2006 through December 2010. SETTING: Community-based and clinical setting. PARTICIPANTS: The CPTD Screening Trial enrolled 1905 community-dwelling African American female Medicare beneficiaries who were ≥65 years of age and resided in Baltimore, MD. Participants were recruited from health clinics, community centers, health fairs, mailings using Medicare rosters, and phone calls. INTERVENTIONS: Participants were randomized to either: printed educational materials on cancer screening (control group) or printed educational materials + patient navigation services designed to help participants overcome barriers to cancer screening (intervention group). MAIN MEASURE: Self-reported receipt of mammography screening within 2 years of the end of the study. KEY RESULTS: The median follow-up period for participants in this analysis was 17.8 months. In weighted multivariable logistic regression analyses, women in the intervention group had significantly higher odds of being up to date on mammography screening at the end of the follow-up period compared to women in the control group (odds ratio [OR] 2.26, 95 % confidence interval [CI]1.59-3.22). The effect of the intervention was stronger among women who were not up to date with mammography screening at enrollment (OR 3.63, 95 % CI 2.09-6.38). CONCLUSION: Patient navigation among urban African American Medicare beneficiaries increased self-reported mammography utilization. The results suggest that patient navigation for mammography screening should focus on women who are not up to date on their screening.

School-based nutrition programs produced a moderate increase in fruit and vegetable consumption: meta and pooling analyses from 7 studies.

OBJECTIVE: To evaluate, through study- and individual-level analyses of data from 7 studies, the effectiveness of school-based nutrition interventions on child fruit and vegetable (FV) consumption. DESIGN: To find original studies on school-based nutrition interventions, the authors searched electronic databases from 1990 to 2002. First authors of the 13 eligible studies were contacted to request their data. Data from 7 studies were received for inclusion in this pooled analysis. SETTING: Schools. PARTICIPANTS: 8156 children were matched from pretest to posttest. Participants were primarily elementary school-aged (75.5%) and white (66%), and 50.4% were males. MAIN OUTCOME MEASURES: Net FV difference and net FV relative change (%). ANALYSIS: Data were analyzed at both the study and individual levels. A fitted multivariable fixed-effects model was used to analyze the role of potential covariates on FV intake. Statistical significance was set at alpha = .05. RESULTS: At the individual level, the net difference in FV consumption was 0.45 (95% CI 0.33-0.59) servings; the net relative change was 19% (95% CI 0.15-0.23) servings. CONCLUSIONS AND IMPLICATIONS: School-based nutrition interventions produced a moderate increase in FV intake among children. These results may have implications for chronic disease prevention efforts, including cardiovascular disease and cancer.

Population Health Measurement at Centers for Medicare & Medicaid Services: Bridging the Gap Between Public Health and Clinical Quality.

As Medicare and Medicaid increasingly shift to alternative payment models focused on population-based payments, there is an urgent need to develop measures of population health that can drive health improvement. In response, an assessment and design project established a framework for developing population health measures from a payer perspective, conducted environmental scans of existing measures and available data infrastructure, and conducted a gap analysis informing measure development and infrastructure needs. The work, summarized here, makes recommendations for creating a set of core measures, demonstrates some of the key challenges in applying a traditional quality measure development framework to population health, and complements recent efforts by the National Academy of Medicine and others with a focus on a payer perspective.

Small school-based effectiveness trials increase vegetable and fruit consumption among youth.

This article profiles a research initiative of state health agency-initiated 5 A Day school-based interventions. Four of the seven projects reviewed had significant results, with an average effect size of 0.4 servings of vegetables and fruit. Results are comparable with the larger-scale, well-controlled, and more costly 5 A Day For Better Health efficacy trials. These comparable findings underscore the value of assessing effectiveness of interventions in real-world settings to potentially enable wide-scale implementation of tested strategies. These small effectiveness trials show that school-based interventions are feasible to implement using current and effective strategies, and may facilitate translation of health promotion research to practice. The projects fostered valuable research/practice partnerships at the community level. Limitations across studies included heterogeneity in research methods, participant attrition, and variability in reporting data. Further research is needed to develop standardized, cost-effective dietary assessment methodology for viable dissemination research in community settings.

Gender differences in correlates of colorectal cancer screening among Black Medicare beneficiaries in Baltimore.

BACKGROUND: Previous research has shown colorectal cancer (CRC) screening disparities by gender. Little research has focused primarily on gender differences among older Black individuals, and reasons for existing gender differences remain poorly understood. METHODS: We used baseline data from the Cancer Prevention and Treatment Demonstration Screening Trial. Participants were recruited from November 2006 to March 2010. In-person interviews were used to assess self-reported CRC screening behavior. Up-to-date CRC screening was defined as self-reported colonoscopy or sigmoidoscopy in the past 10 years or fecal occult blood testing in the past year. We used multivariable logistic regression to examine the association between gender and self-reported screening, adjusting for covariates. The final model was stratified by gender to examine factors differentially associated with screening outcomes for males and females. RESULTS: The final sample consisted of 1,552 female and 586 male Black Medicare beneficiaries in Baltimore, Maryland. Males were significantly less likely than females to report being up-to-date with screening (77.5% vs. 81.6%, P = 0.030), and this difference was significant in the fully adjusted model (OR: 0.72; 95% confidence interval, 0.52-0.99). The association between having a usual source of care and receipt of cancer screening was stronger among males compared with females. CONCLUSIONS: Although observed differences in CRC screening were small, several factors suggest that gender-specific approaches may be used to promote screening adherence among Black Medicare beneficiaries. IMPACT: Given disproportionate CRC mortality between White and Black Medicare beneficiaries, gender-specific interventions aimed at increasing CRC screening may be warranted among older Black patients.

Association between lifestyle factors and CpG island methylation in a cancer-free population.

BACKGROUND: Many risk factors have been associated with cancer, such as age, family history, race, smoking, high-fat diet, and poor nutrition. It is important to reveal the molecular changes related to risk factors that could facilitate early detection, prevention, and overall control of cancer. METHODS: We selected six cancer-specific methylated genes that have previously been reported in primary tumors and have also been detected in different bodily fluids of cancer patients. Here, we used quantitative fluorogenic real-time methylation-specific PCR in plasma DNA samples for the detection of methylation changes from an asymptomatic population who do not have any known cancer. RESULTS: The promoter methylation frequencies of the studied genes were as follows: APC (7%), CCND2 (22%), GSTP1 (2%), MGMT (9%), RARbeta2 (29%), and P16 (3%). Promoter methylation of at least one of the genes analyzed was observed in approximately 46% (72 of 157) of the samples by binary dichotomization. Promoter hypermethylation of at least two genes was detected in 17% (26 of 157) of the samples. RARbeta2 methylation was observed in 45% of subjects who had a high-fat diet in contrast with those who had a low-fat diet (23%; P = 0.007). DISCUSSION: Our findings may help to elucidate early methylation changes that may lead to cancer development. These methylation changes could be due to exposure to risk factors and may be useful for cancer prevention measures such as changes in lifestyle. Longitudinal follow-up of a high-risk population is needed to understand the association of methylation of candidate genes in cancer development.

Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review.

Racial and ethnic minorities, older adults, rural residents, and individuals of low socioeconomic status are underrepresented among participants in cancer-related trials. The authors conducted a systematic review to determine the barriers to participation of underrepresented populations in cancer-related trials. Their search included English-language publications that reported original data on the recruitment of underrepresented groups to cancer treatment or prevention trials between 1966 and December 2005 in multiple electronic databases. They also hand-searched titles in 34 journals from January 2003 to December 2005 and they examined reference lists for eligible articles. Titles and abstracts were reviewed to identify relevant studies. Data on barriers to participation were synthesized both qualitatively and based on statistically significant associations with trial enrollment. Of 5257 studies that were cited, 65 studies were eligible for inclusion in the current analysis, including 46 studies on recruitment into cancer therapeutic trials, 15 studies on recruitment into prevention trials, and 4 studies on recruitment into both prevention and treatment trials. Numerous factors were reported as barriers to participation in cancer-related trials. However, only 20 of the studies reported statistically significant associations between hypothesized barriers and enrollment. The available evidence had limitations in quality regarding representativeness, justification of study methods, the reliability and validity of data-collection methods, potential for bias, and data analysis. The results indicated that underrepresented populations face numerous barriers to participation in cancer-related trials. The current systematic review highlighting the literature on recruitment of underrepresented populations to cancer trials and may be used as the evidence base toward developing an agenda for etiologic and intervention research to reduce the disparities in participation in cancer-related trials.

Applying justice in clinical trials for diverse populations.

BACKGROUND: Considerable attention has focused on increasing clinical trial participation for members of "underrepresented groups". However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation. PURPOSE: To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation. METHODS: In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation. RESULTS: Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures. LIMITATIONS: The suggestions offered based on this conceptual analysis need to be tested empirically. CONCLUSIONS: Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate.

Provider roles in the recruitment of underrepresented populations to cancer clinical trials.

BACKGROUND: Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider-related factors influencing recruitment of underrepresented populations to cancer clinical trials. METHODS: To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand-searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators. RESULTS: Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case-control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study. CONCLUSIONS: A heterogeneous body of evidence suggests that several provider-related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors.

Defining "success" in recruitment of underrepresented populations to cancer clinical trials: moving toward a more consistent approach.

Although medically underserved groups bear a heavy burden of cancer disease and governmental agencies have required inclusion of minorities and women in cancer clinical trials since 1993, many of these groups are underrepresented in cancer prevention or treatment clinical trials. To assess and enhance recruitment of underrepresented populations into cancer-related clinical trials, investigators and governmental agencies need consistent measurement approaches for recruitment that can be applied to diverse settings where trials are conducted. We conducted a systematic review to evaluate what measurement approaches were used to evaluate the success of recruitment of underrepresented groups into cancer prevention or treatment trials, and whether these recruitment goals were stated a priori. Only two articles reported an a priori recruitment goal. The recruitment measurement approaches varied considerably, with no consistent standard, especially for individual trials. By using the empiric evidence from this review in conjunction with the National Institutes of Health (NIH) guidelines, we constructed a framework for choosing consistent a priori recruitment goals for underrepresented groups based on the research question and study location. Using consistent measurement approaches for underrepresented groups will improve comparability of recruitment strategies across trials, improve equity in distribution of benefits and burdens of cancer-related clinical trials, and may improve applicability of trial results to multiple populations.

Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials.

BACKGROUND: Certain populations, including racial and ethnic minorities and older persons, have had a history of low participation in cancer-related trials, yet there has been little information reported on recruitment strategies tailored to improve their enrollment. METHODS: We conducted a systematic literature review to examine the methods used to study recruitment of underrepresented populations into cancer prevention and treatment trials and examined the studies that compared the efficacy and/or effectiveness of different recruitment strategies. We performed an electronic search through multiple databases including PubMed and a hand search of 34 journals. Potential studies were pulled and underwent title, abstract, and article review by at least two investigators. RESULTS: Fourteen articles examined recruitment of underrepresented populations into cancer trials and, of these, five compared efficacy or effectiveness of different strategies for recruitment of underrepresented populations into randomized or concurrent controlled trials. These five studies used various strategies but only three reported that specific recruitment strategies, such as media campaigns and church-based project sessions, resulted in improvement in accrual to cancer trials. CONCLUSION: There is limited evidence for efficacious or effective strategies to recruit underrepresented populations in cancer-related trials. The available evidence cannot be generalized to these heterogeneous groups. Further study is needed on efficacious strategies for recruitment of underrepresented populations into cancer-related trials.