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.

The impact of socioeconomic status on changes in cancer prevention behavior during the COVID-19 pandemic.

BACKGROUND: The impacts of socioeconomic status (SES) on COVID-19-related changes in cancer prevention behavior have not been thoroughly investigated. We conducted a cohort study to examine the effects of SES on changes in cancer prevention behaviors during the COVID-19 pandemic. METHODS: We invited adult participants from previous studies conducted at Ohio State University to participate in a study assessing the impact of COVID-19 on various behaviors. Post-COVID-19 cancer prevention behaviors, including physical activity, daily intake of fruits and vegetables, alcohol and tobacco consumption, and qualitative changes in post-COVID-19 behaviors relative to pre-COVID levels, were used to construct a prevention behavior change index that captures the adherence status and COVID-related changes in each behavior, with higher index scores indicating desirable changes in prevention behaviors. Participants were classified into low, middle, or high SES based on household income, education, and employment status. Adjusted regression models were used to examine the effects of SES on changes in cancer prevention behaviors during the COVID-19 pandemic. RESULTS: The study included 6,136 eligible participants. The average age was 57 years, 67% were women, 89% were non-Hispanic Whites, and 33% lived in non-metro counties. Relative to participants with high SES, those with low SES had a 24% [adjusted relative ratio, aRR = 0.76 (95%CI 0.72-0.80)], 11% [aRR = 0.89 (95%CI 0.86-0.92)], and 5% [aRR = 0.95 (95%CI 0.93-0.96)], lower desirable changes in prevention behaviors for physical activity, fruit and vegetable intake, and tobacco use, respectively. Low SES had a higher desirable change in alcohol consumption prevention behaviors, 16% [aRR = 1.16 (95%CI 1.13-1.19)] relative to high SES. The adjusted odds of an overall poor change in prevention behavior were adjusted odds ratio (aOR) 1.55 (95%CI 1.27 to 1.89) and aOR 1.40 (95%CI 1.19 to 1.66), respectively, higher for those with low and middle SES relative to those with high SES. CONCLUSION: The adverse impacts of COVID-19 on cancer prevention behaviors were seen most in those with lower SES. Public health efforts are currently needed to promote cancer prevention behaviors, especially amongst lower SES adults.

Impact of the COVID-19 Pandemic on Cancer Screening Delays.

PURPOSE: To examine delays in cancer screenings during the COVID-19 pandemic. METHODS: Participants from previous studies (N = 32,989) with permissions to be recontacted were invited to complete a survey between June and November 2020. Participants (n = 7,115) who met the age range for cancer screenings were included. Participants were asked if they planned to have and then if they postponed a scheduled mammogram, Pap test, stool blood test, colonoscopy, or human papillomavirus (HPV) test. Logistic regression was used to determine the factors associated with cancer screening delays for each planned test. RESULTS: The average age was 57.3 years, 75% were female, 89% were non-Hispanic White, 14% had public insurance, and 34% lived in rural counties. Those who planned cancer screenings (n = 4,266, 60%) were younger, more likely to be female, with higher education, had private insurance, and lived in rural counties. Specifically, 24% delayed a mammogram (n = 732/2,986), 27% delayed a Pap test (n = 448/1,651), 27% delayed an HPV test (n = 59/220), 11% delayed a stool blood test (n = 44/388), and 36% delayed a colonoscopy (n = 304/840). Age, race/ethnicity, education, and health insurance were associated with delays in cancer screenings (all P < .05). Compared with non-Hispanic White women, non-Hispanic Black women had lower odds of delaying a mammogram (odds ratio [OR], 0.60; 95% CI, 0.39 to 0.94), Hispanic women had higher odds of delaying Pap test (OR, 2.46; 95% CI, 1.34 to 4.55), and women with other race/ethnicity had higher odds of delaying both Pap test (OR, 2.38; 95% CI, 1.41 to 4.02) and HPV test (OR, 5.37; 95% CI, 1.44 to 19.97). CONCLUSION: Our findings highlighted the urgency for health care providers to address the significant delays in cancer screenings in those most likely to delay. Strategies and resources are needed to help those with barriers to receiving guideline-appropriate cancer screening.

Feasibility of implementing a text-based symptom-monitoring program of endometrial, ovarian, and breast cancer patients during treatment.

PURPOSE: To evaluate the feasibility of implementing systematic patient symptom monitoring during treatment using a smartphone. METHODS: Endometrial [n = 50], ovarian [n = 70] and breast [n = 193] cancer patients participated in text-based symptom reporting for up to 12 months. In order to promote equity, patients without a smartphone were provided with a device, with the phone charges paid by program funds. Each month, patients completed the Patient Health Questionnaire (PHQ-9), and 4 single items assessing fatigue, sleep quality, pain, and global quality of life during the past 7 days rated on a 0 (low) -10 (high) scale. Patients' responses were captured using REDCap, with oncologists receiving monthly feedback. Lay navigators provided assistance to patients with non-medical needs. RESULTS: Patients utilizing this voluntary program had an overall mean age of 60.5 (range 26-87), and 85% were non-Hispanic white. iPhones were provided to 42 patients, and navigation services were used by 69 patients. Average adherence with monthly surveys ranged between 75-77%, with breast patients having lower adherence after 5 months. The most commonly reported symptoms across cancer types were moderate levels (scores of 4-7) of fatigue and sleep disturbance. At 6 months, 71-77% of all patients believed the surveys were useful to them and their health care team. CONCLUSIONS: We established the feasibility of initiating and managing patients in a monthly text-based symptom-monitoring program. The provision of smartphones and patient navigation were unique and vital components of this program.

Scripted tours through a giant inflatable colon: An innovative and effective educational tool in urban communities.

Colorectal cancer (CRC) is the second leading cause of cancer-related death among men and women in the US and mortality rates are increasing among young adults. Although CRC is largely preventable with screening and often curable when detected at an early stage, many age-appropriate individuals remain unscreened or are not currently up-to-date with screening. We aimed to examine the impact of providing guided, scripted tours through an inflatable colon on three domains: CRC knowledge, likelihood of communicating about CRC with others, and the intention to be screened for CRC in a diverse, urban population. The inflatable walk-through colon was exhibited at five community events in Franklin County, Ohio between March 2015 and August 2016. A pre and posttest research design and composite scores were stratified into three age groups (<45 years, 45-49 years and ≥ 50 years of age). Descriptive statistics were used to describe and compare demographic characteristics. Logistic regression was used to examine potential associations between demographic factors and the three outcomes of interest. These tours led to statistically significant increases in CRC knowledge, communication, and intention to undergo CRC screening among participants in all three age cohorts. In addition, the intention of undergo screening after a tour among individuals<45 years of age were nearly three times that of those older than 50 (OR = 2.66; 95%CI = 1.49-4.75). Overall, this study supports the use of scripted tours through an inflatable colon exhibit as a potentially effective intervention to increase age-appropriate CRC screening uptake.

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.

Inherited alterations of TGF beta signaling components in Appalachian cervical cancers.

PURPOSE: This study examined targeted genomic variants of transforming growth factor beta (TGFB) signaling in Appalachian women. Appalachian women with cervical cancer were compared to healthy Appalachian counterparts to determine whether these polymorphic alleles were over-represented within this high-risk cancer population, and whether lifestyle or environmental factors modified the aggregate genetic risk in these Appalachian women. METHODS: Appalachian women's survey data and blood samples from the Community Awareness, Resources, and Education (CARE) CARE I and CARE II studies (n = 163 invasive cervical cancer cases, 842 controls) were used to assess gene-environment interactions and cancer risk. Polymorphic allele frequencies and socio-behavioral demographic measurements were compared using t tests and χ2 tests. Multivariable logistic regression was used to evaluate interaction effects between genomic variance and demographic, behavioral, and environmental characteristics. RESULTS: Several alleles demonstrated significant interaction with smoking (TP53 rs1042522, TGFB1 rs1800469), alcohol consumption (NQO1 rs1800566), and sexual intercourse before the age of 18 (TGFBR1 rs11466445, TGFBR1 rs7034462, TGFBR1 rs11568785). Interestingly, we noted a significant interaction between "Appalachian self-identity" variables and NQO1 rs1800566. Multivariable logistic regression of cancer status in an over-dominant TGFB1 rs1800469/TGFBR1 rs11568785 model demonstrated a 3.03-fold reduction in cervical cancer odds. Similar decreased odds (2.78-fold) were observed in an over-dominant TGFB1 rs1800469/TGFBR1 rs7034462 model in subjects who had no sexual intercourse before age 18. CONCLUSIONS: This study reports novel associations between common low-penetrance alleles in the TGFB signaling cascade and modified risk of cervical cancer in Appalachian women. Furthermore, our unexpected findings associating Appalachian identity and NQO1 rs1800566 suggests that the complex environmental exposures that contribute to Appalachian self-identity in Appalachian cervical cancer patients represent an emerging avenue of scientific exploration.

Correlates of Rural, Appalachian, and Community Identity in the CITIES Cohort.

PURPOSE: To determine correlates of rural, Appalachian, and community identity among a cohort of participants in the Community Initiative Towards Improving Equity and Health Status (CITIES) project. METHODS: Mixed linear and logistic regression effects models were utilized to determine correlates of 3 outcomes: 1) community identity, 2) rural identity, and 3) Appalachian identity among participants in the Ohio CITIES project. FINDINGS: Distinct demographic characteristics were found to be associated with each of the outcomes. For community identity, while no differences were found for rural or urban participants, those who were single or never married (P < .0001) as well as those who graduated from college (P = .0005) reported significantly lower community identity scores than married individuals with less than a college education. Those who resided in an Appalachian county reported higher community identity scores (P = .0009) than non-Appalachian residents. For rural identity, those who did not identify as Christian (P = .018) as well as those who identified as Democrat (P = .027) reported significantly lower rural identity scores than others. Lastly, for Appalachian identity, county-level percentage of families in poverty (P = .06), as well as gender (P = .05), were associated with self-reported Appalachian identity, but these effects were only marginally significant. CONCLUSIONS: Although community, rural, and Appalachian identity may be viewed as similar due to their measure of attachment to a place, results from this study suggest that there are distinct individual and area-level correlates associated with community, rural, and Appalachian identity.

The CITIES Project: Understanding the Health of Underrepresented Populations in Ohio.

BACKGROUND: Ohio, the catchment area of The Ohio State University Comprehensive Cancer Center (OSUCCC), includes diverse populations with different cancer profiles. As part of the National Cancer Institute (NCI)-funded initiative to conduct population health assessments in cancer center catchment areas, the OSUCCC surveyed residents, focusing on factors contributing to cancer disparities in Ohio populations. METHODS: Two sampling strategies were used: (i) probability sampling of mailing lists and (ii) convenience sampling at community events, coupled with phone/in-person/web surveys. Survey items were chosen along multilevel framework constructs, used in concert with other funded NCI-Designated Cancer Centers. Multivariable logistic regression models investigated predictors associated with health behaviors, cancer beliefs, knowledge, and screening. RESULTS: The sample of 1,005 respondents were white (46.6%), African American (24.7%), Hispanic (13.7%), Somali (7.6%), and Asian (7.5%). A total of 216 respondents were Appalachian. Variations in cancer attitudes, knowledge, and behaviors were noted by racial/ethnic and geographic group. Multivariable models identified individuals with less financial security as less likely to exercise or be within guidelines for screening, but more likely to smoke and have a poor diet. At the community-level, measures of poverty were highest in Appalachia, whereas children in female-headed households were greater in urban minority areas. CONCLUSIONS: This population health assessment reinforced the diversity of the OSUCCC catchment area. These populations are ripe for implementation science strategies, focusing in communities and clinics that serve vulnerable populations. IMPACT: Understanding attitudes, knowledge, and behaviors of this population can assist tailoring outreach and research strategies to lessen the cancer burden.

Financial burden among older, long-term cancer survivors: Results from the LILAC study.

BACKGROUND: Increasing attention is being paid to financial burdens of cancer survivorship, but little is known about the prevalence and predictors of these burdens in older, long-term survivors. METHODS: We used data from 6012 participants diagnosed with cancer since enrolling in the Women's Health Initiative, and who participated in the Life and Longevity After Cancer (LILAC) ancillary study to estimate prevalence and identify predictors of financial burden. We used logistic regression to identify sociodemographic, socioeconomic, health- and cancer-related factors associated with financial burden and backward selection to build a final multivariable model. RESULTS: Average age at LILAC participation was 79 and 9.2 years had elapsed since cancer diagnosis. Overall, 6% experienced some form of financial burden, including having an insurance company refuse a claim (2.6%), being denied loans or insurance due to cancer history (2.2%), or experiencing significant indebtedness (1.8%, including facing large debts or bills or declaring bankruptcy). Eight predictors remained associated (P < 0.05) with financial burden in the fully-adjusted model: younger age, shorter time since diagnosis, African-American race, household income <$20 000/year, modified Charlson comorbidity score ≥2, receipt of chemotherapy, regional stage at diagnosis, and no private health insurance. Education, cancer site, social support, receipt of radiation, and receipt of hormone therapy were not associated with financial burden. Predictors differed between types of financial burden experienced and age at diagnosis (<65 vs 65+). CONCLUSION: Cancer-related financial burden was rare in this population of older, female long-term cancer survivors. The identification of several socioeconomic, health-related and demographic predictors of financial burden may suggest targets of intervention to reduce financial burdens. PRECIS: Financial burden was uncommon in older, female, long-term survivors. Predictors of financial burden included age, race, income, comorbidities, time since diagnosis, stage, insurance, and receipt of chemotherapy.

Disparities in breast cancer tumor characteristics, treatment, time to treatment, and survival probability among African American and white women.

African American (AA) women have a 42% higher breast cancer death rate compared to white women despite recent advancements in management of the disease. We examined racial differences in clinical and tumor characteristics, treatment and survival in patients diagnosed with breast cancer between 2005 and 2014 at a single institution, the James Cancer Hospital, and who were included in the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute Cancer Registry in Columbus OH. Statistical analyses included likelihood ratio chi-square tests for differences in proportions, as well as univariate and multivariate Cox proportional hazards regressions to examine associations between race and overall and progression-free survival probabilities. AA women made up 10.2% (469 of 4593) the sample. Average time to onset of treatment after diagnosis was almost two times longer in AA women compared to white women (62.0 days vs 35.5 days, p < 0.0001). AA women were more likely to report past or current tobacco use, experience delays in treatment, have triple negative and late stage breast cancer, and were less likely to receive surgery, especially mastectomy and reconstruction following mastectomy. After adjustment for confounding factors (age, grade, and surgery), overall survival probability was significantly associated with race (HR = 1.33; 95% CI 1.03-1.72). These findings highlight the need for efforts focused on screening and receipt of prompt treatment among AA women diagnosed with breast cancer.

Telomere Length and Neighborhood Circumstances: Evaluating Biological Response to Unfavorable Exposures.

Background: Multilevel frameworks suggest neighborhood circumstances influence biology; however, this relationship is not well studied. Telomere length (TL) shortening has been associated with individual-level and neighborhood-level exposures and disease and may provide insights into underlying biologic mechanisms linking neighborhood with biology. To support neighborhood-biology investigations, we sought to determine the independent effect of neighborhood exposures on TL using standard multilevel linear regression models and quantile regression, a nonlinear, social science method applicable for testing the biologic hypothesis that extremes of the TL distribution are related to poor outcomes.Methods: In a multicenter, cross-sectional study, blood TL was measured in 1,488 individuals from 127 census tracts in three U.S. regions using terminal restriction fragment assays. Multilevel linear and quantile regression models were adjusted for individual-level race, education, perceived stress, and depression. Neighborhood exposures included population density, urban/residential crowding, residential stability/mobility, and socioeconomic status.Results: TL was not associated with any neighborhood variable using linear models, but quantile regression revealed inverse associations between population density and urban crowding at the lower tails of the TL distribution [5th (population density P = 0.03; urban crowding P = 0.002), 50th (both P < 0.001), 75th percentiles (both P < 0.001)]. TL was related to residential stability at the upper tail (95th percentile P = 0.006).Conclusions: Findings support the use of nonlinear statistical methods in TL research and suggest that neighborhood exposures can result in biological effects.Impact: TL may serve as an underlying example of a biologic mechanism that can link neighborhood with biology, thus supporting multilevel investigations in future studies. Cancer Epidemiol Biomarkers Prev; 26(4); 553-60. ©2017 AACRSee all the articles in this CEBP Focus section, "Geospatial Approaches to Cancer Control and Population Sciences."

Race, Ethnicity, Psychosocial Factors, and Telomere Length in a Multicenter Setting.

BACKGROUND: Leukocyte telomere length(LTL) has been associated with age, self-reported race/ethnicity, gender, education, and psychosocial factors, including perceived stress, and depression. However, inconsistencies in associations of LTL with disease and other phenotypes exist across studies. Population characteristics, including race/ethnicity, laboratory methods, and statistical approaches in LTL have not been comprehensively studied and could explain inconsistent LTL associations. METHODS: LTL was measured using Southern Blot in 1510 participants from a multi-ethnic, multi-center study combining data from 3 centers with different population characteristics and laboratory processing methods. Main associations between LTL and psychosocial factors and LTL and race/ethnicity were evaluated and then compared across generalized estimating equations(GEE) and linear regression models. Statistical models were adjusted for factors typically associated with LTL(age, gender, cancer status) and also accounted for factors related to center differences, including laboratory methods(i.e., DNA extraction). Associations between LTL and psychosocial factors were also evaluated within race/ethnicity subgroups (Non-hispanic Whites, African Americans, and Hispanics). RESULTS: Beyond adjustment for age, gender, and cancer status, additional adjustments for DNA extraction and clustering by center were needed given their effects on LTL measurements. In adjusted GEE models, longer LTL was associated with African American race (Beta(ß)(standard error(SE)) = 0.09(0.04), p-value = 0.04) and Hispanic ethnicity (ß(SE) = 0.06(0.01), p-value = 0.02) compared to Non-Hispanic Whites. Longer LTL was also associated with less than a high school education compared to having greater than a high school education (ß(SE) = 0.06(0.02), p-value = 0.04). LTL was inversely related to perceived stress (ß(SE) = -0.02(0.003), p<0.001). In subgroup analyses, there was a negative association with LTL in African Americans with a high school education versus those with greater than a high school education(ß(SE) = -0.11(0.03), p-value<0.001). CONCLUSIONS: Laboratory methods and population characteristics that differ by center can influence telomere length associations in multicenter settings, but these effects could be addressed through statistical adjustments. Proper evaluation of potential sources of bias can allow for combined multicenter analyses and may resolve some inconsistencies in reporting of LTL associations. Further, biologic effects on LTL may differ under certain psychosocial and racial/ethnic circumstances and could impact future health disparity studies.

Participants' barriers to diagnostic resolution and factors associated with needing patient navigation.

BACKGROUND: Patient navigation (PN) may improve cancer care by identifying and removing patient-reported barriers to care. In 2012, the American College of Surgeons Commission on Cancer (CoC) announced that health care facilities seeking CoC accreditation must have PN processes in place by January 1, 2015. Given these unfunded mandates, hospitals are looking for cost-effective ways to implement PN. This study examined demographic and psychosocial predictors of barriers to diagnostic resolution among individuals with a cancer screening abnormality enrolled in the Ohio Patient Navigation Research Project. METHODS: Data were obtained from patients who received care at 1 of 9 Ohio Patient Navigation Research Project intervention clinics. Descriptive statistics and logistic regression models were used. RESULTS: There were 424 participants, and 151 (35.6%) reported a barrier to diagnostic resolution within 90 days of study consent. The most commonly reported barriers were misconceptions about a test or treatment (16.4%), difficulty in communicating with the provider (15.0%), and scheduling problems (11.5%). Univariate analyses indicated that race, education, employment, income, insurance, clinic type, friend support, and physical and psychological functioning were significantly associated with reporting a barrier to diagnostic resolution. Multivariate analyses found that comorbidities (odds ratio, 1.65; 95% confidence interval, 1.04-2.61) and higher intrusive thoughts and feelings (odds ratio, 1.25; 95% confidence interval, 1.10-1.41) were significantly associated with reporting a barrier to diagnostic resolution. CONCLUSIONS: The results suggest that demographic and psychosocial factors are associated with barriers to diagnostic resolution. To ensure compliance with the CoC mandate and provide timely care to all patients, CoC-accredited facilities can systematically identify the patients most likely to have barriers to care and assign them to PN.

Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial.

BACKGROUND: Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids. We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women. We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. METHODS: Overweight or obese premenopausal women were randomized to a low-fat (n=41) or low-carbohydrate (n=38) diet. As part of the 52-week Lifestyle Eating and Fitness (LEAF) intervention trial, we fit linear mixed models to determine whether a change in outcome differed by treatment arm. RESULTS: Within-group trends in blood pressure and blood lipids did not differ (p>0.30). Across study arms, there was a significant decrease in systolic blood pressure (SBP, 3 mm Hg, p=0.01) over time, but diastolic blood pressure (DBP) did not change significantly over the course of the study. Blood lipids (total cholesterol [TC], low-density lipoproteins [LDL], and high-density lipoproteins [HDL]) all exhibited nonlinear trends over time (p<0.01); each decreased initially but returned to levels comparable to baseline by study conclusion (p>0.20). We observed a decline in SBP among women who were hypertensive at baseline (p<0.01), but hypercholesterolemia at baseline did not affect trends in blood lipids (p>0.40). CONCLUSIONS: Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women. However, a decrease in SBP was the only favorable change that was sustained in this study population. These changes can be maintained over the course of a 1-year intervention, yet changes in blood lipids may be less sustainable.

Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial.

PURPOSE: The most effective dietary pattern for breast cancer prevention has been greatly debated in recent years. Studies have examined hypocaloric diets, with particular emphasis on macronutrient composition, yielding inconclusive data. The objective of this study was to examine the effects of calorie-restricted low-fat and low-carbohydrate diets (LFD and LCD, respectively) on circulating adipokines among overweight and obese premenopausal women. METHODS: Seventy-nine overweight and obese premenopausal women were randomized to either LFD or LCD, with increased physical activity, for 52 weeks. Serum adiponectin, leptin and the adiponectin-to-leptin ratio (A/L) were measured at baseline, and at weeks 34 and 52 to assess intervention effects. RESULTS: While there were no significant changes in serum adiponectin concentrations following the LCD and LFD interventions, leptin concentrations significantly decreased by week 34 of the intervention period (LCD: 35.3%, P = 0.004; LFD: 30.0%, P = 0.01), with no difference by intervention arm. At week 52, these reductions were statistically non-significant, indicating a return to baseline levels by the end of the intervention. While there were non-significant increases in the A/L ratio following the LCD and LFD intervention arms, the overall trend, across groups, was marginally significant (P = 0.05) with increases of 16.2% and 35.1% at weeks 34 and 52, respectively. CONCLUSIONS: These findings suggest that caloric-restricted LCD and LFD dietary patterns favorably modify leptin and possibly the A/L ratio, and lend support to the hypothesis that these interventions may be effective for obesity-related breast cancer prevention through their effects on biomarkers involved in metabolic pathways. CLINICAL TRIAL REGISTRATION NUMBER: NCT01559194.

Effects of tomato and soy on serum adipokine concentrations in postmenopausal women at increased breast cancer risk: a cross-over dietary intervention trial.

CONTEXT: Breast cancer risk among postmenopausal women increases as body mass index increases. Practical preventive methods to reduce risk of breast cancer are lacking. Few studies have investigated the effects of carotenoids and isoflavones on circulating adipokines in postmenopausal women. OBJECTIVE: The aim was to examine the effects of lycopene- and isoflavone-rich diets on serum adipokines. DESIGN: This was a 26-week, two-arm, longitudinal crossover trial. SETTING: Participants were recruited from clinics at The Ohio State University Comprehensive Cancer Center. PARTICIPANTS: Seventy postmenopausal women at increased breast cancer risk participated in the study. The mean age and body mass index of participants was 57.2 years and 30.0 kg/m(2), respectively; the study was comprised of 81.4% whites. INTERVENTIONS: The interventions included 10 weeks of consumption of a tomato-based diet (≥25 mg lycopene daily) and 10 weeks of consumption of a soy-based diet (≥40 g of soy protein daily), with a 2-week washout in between. MAIN OUTCOME MEASURES: Changes in serum adiponectin, leptin, and the adiponectin to leptin ratio were examined for each intervention through linear mixed models, with ratio estimates corresponding to postintervention adipokine concentrations relative to preintervention concentrations. RESULTS: After the tomato intervention, among all women, adiponectin concentration increased (ratio 1.09, 95% confidence interval (CI) 1.00-1.18), with a stronger effect observed among nonobese women (ratio 1.13, 95% CI 1.02-1.25). After the soy intervention, adiponectin decreased overall (ratio 0.91, 95% CI 0.84-0.97), with a larger reduction observed among nonobese women (ratio 0.89, 95% CI 0.81-0.98). Overall, no significant changes in leptin or the adiponectin to leptin ratio were observed after either intervention. CONCLUSIONS: Increasing dietary consumption of tomato-based foods may beneficially increase serum adiponectin concentrations among postmenopausal women at increased breast cancer risk, especially those who are not obese. Additional studies are essential to confirm these effects and to elucidate the specific mechanisms that may make phytonutrients found in tomatoes practical as breast cancer chemopreventive agents.

Effects of a walking intervention using mobile technology and interactive voice response on serum adipokines among postmenopausal women at increased breast cancer risk.

Practical methods to reduce the risk of obesity-related breast cancer among high-risk subgroups are lacking. Few studies have investigated the effects of exercise on circulating adipokines, which have been shown to be associated with obesity and breast cancer. The aim of this study was to examine the effects of a walking intervention on serum adiponectin, leptin, and the adiponectin-to-leptin ratio (A/L). Seventy-one overweight and obese postmenopausal women at increased risk of developing breast cancer were stratified by BMI (25-30 kg/m(2) or >30 kg/m(2)) and randomized to a 12-week, two-arm walking intervention administered through interactive voice response (IVR) and mobile devices. The intervention arms were IVR + coach and IVR + no-coach condition. Pre-post changes in serum adiponectin, leptin, and the A/L ratio were examined using mixed regression models, with ratio estimates (and 95 % confidence intervals [CI]) corresponding to postintervention adipokine concentrations relative to preintervention concentrations. While postintervention effects included statistically significant improvements in anthropometric measures, the observed decreases in adiponectin and leptin (ratio = 0.86, 95 % CI 0.74-1.01, and ratio = 0.94, 95 % CI 0.87-1.01, respectively) and increase in A/L ratio = 1.09, 95 % CI 0.94-1.26) were not significant. Thus, these findings do not support significant effects of the walking intervention on circulating adipokines among overweight and obese postmenopausal women. Additional studies are essential to determine the most effective and practical lifestyle interventions that can promote beneficial modification of serum adipokine concentrations, which may prove useful for obesity-related breast cancer prevention.

The Ohio Patient Navigation Research Program: does the American Cancer Society patient navigation model improve time to resolution in patients with abnormal screening tests?

BACKGROUND: Patient navigation (PN) has been suggested as a way to reduce cancer health disparities; however, many models of PN exist and most have not been carefully evaluated. The goal of this study was to test the Ohio American Cancer Society model of PN as it relates to reducing time to diagnostic resolution among persons with abnormal breast, cervical, or colorectal cancer screening tests or symptoms. METHODS: A total of 862 patients from 18 clinics participated in this group-randomized trial. Chart review documented the date of the abnormality and the date of resolution. The primary analysis used shared frailty models to test for the effect of PN on time to resolution. Crude HR were reported as there was no evidence of confounding. RESULTS: HRs became significant at 6 months; conditional on the random clinic effect, the resolution rate at 15 months was 65% higher in the PN arm (P = 0.012 for difference in resolution rate across arms; P = 0.009 for an increase in the HR over time). CONCLUSIONS: Participants with abnormal cancer screening tests or symptoms resolved faster if assigned to PN compared with those not assigned to PN. The effect of PN became apparent beginning six months after detection of the abnormality. IMPACT: PN may help address health disparities by reducing time to resolution after an abnormal cancer screening test.