A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes.

PURPOSE: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC), and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet-promoting weight loss is feasible and might improve QOL. METHODS: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. RESULTS: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3 % total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8 % to 20.4 % percent calories from fat, p < 0.001) and fiber content (12.7 to 30.8 g fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95 % confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). CONCLUSIONS: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes.

PURPOSE: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. METHODS: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole-food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. RESULTS: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01), and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15-3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. CONCLUSION: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight, cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial.

PURPOSE: A growing body of research suggests that inflammation plays a role in many chemotherapy-related toxicities such as fatigue, anxiety, and neuropathy. Regular exercise can change levels of individual cytokines (e.g., reducing IL-6, increasing IL-10); however, it is not known whether exercise during chemotherapy affects relationships between cytokines (i.e., whether cytokine concentrations change collectively vs. independently). This study assessed how 6 weeks of exercise during chemotherapy affected relationships between changes in concentrations of several cytokines. METHODS: This is a secondary analysis of a randomized trial studying 6 weeks of moderate-intensity walking and resistance exercise during chemotherapy compared with chemotherapy alone. At pre- and post-intervention, patients provided blood to assess serum concentrations of cytokines IL-1ß, IL-6, IL-8, IL-10, and IFN-γ, and receptor sTNFR1. We investigated relationships between cytokines using the correlations between changes in cytokine concentrations from pre- to post-intervention. RESULTS: We obtained complete data from 293 patients (149 randomized to exercise). Exercise strengthened the correlation between concentration changes of IL-10 and IL-6 (r = 0.44 in exercisers vs. 0.11 in controls; p = 0.001). We observed the same pattern for IL-10:IL-1ß and IL-10:sTNFR1. Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1ß (p = 0.099, trend-level significance). CONCLUSIONS: Our hypothesis-generating work suggests that regular exercise during 6 weeks of chemotherapy may cause certain cytokine concentrations to change collectively (not independently). This work enhances our understanding of relationships between cytokines and complements traditional analyses of cytokines in isolation. Future work should test for replication and relationships to patient outcomes. TRIAL REGISTRATION: Clinical Trials.gov, # NCT00924651, http://www.clinicaltrials.gov .

Multimedia psychoeducation for patients with cancer who are eligible for clinical trials: A randomized clinical trial.

BACKGROUND: Supporting patients' decision making about clinical trials may enhance trial participation. To date, few theory-based interventions have been tested to address this issue. The objective of the current study was aimed to evaluate the effect of a multimedia psychoeducation (MP) intervention, relative to a print education (PE) intervention, on patients' decision support needs and attitudes about clinical trials. METHODS: Patients with cancer who were eligible for participation in a National Cancer Institute therapeutic cancer clinical trial were recruited through the nationwide University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program from 2014 to 2016 and were randomized to the MP or PE intervention. Assessments at baseline (before intervention), postintervention, and at a 2-month follow-up visit included patients' decision support needs, attitudes regarding clinical trials, and clinical trial participation. RESULTS: In total, 418 patients with various types of cancer were recruited (ages 26-89 years). Relative to the PE intervention, the MP intervention did not significantly affect decision support needs. However, patients in the MP arm reported significantly more positive attitudes about clinical trials and were more likely to participate in a clinical trial than those in the PE arm (69% vs 62%; P = .01). Furthermore, an improvement in attitudes about clinical trials significantly mediated the effect of the intervention on participation in clinical trials. CONCLUSIONS: The MP intervention was able to improve patient attitudes toward clinical trials compared with the PE intervention, and this improvement led to increased rates of participation in trials. The MP intervention could be disseminated to improve attitudes about clinical trials among patients with cancer.

Feasibility and acceptability of brief behavioral therapy for cancer-related insomnia: effects on insomnia and circadian rhythm during chemotherapy: a phase II randomised multicentre controlled trial.

BACKGROUND: This phase II RCT was conducted to determine the feasibility and acceptability of brief behavioral therapy for cancer-related insomnia (BBT-CI) in breast cancer patients undergoing chemotherapy. We also assessed the preliminary effects of BBT-CI on insomnia and circadian rhythm in comparison to a Healthy Eating Education Learning control condition (HEAL). METHODS: Of the 71 participants recruited, 34 were randomised to receive BBT-CI and 37 to receive HEAL. Oncology staff was trained to deliver the intervention in four community clinics affiliated with the NCI. Insomnia was assessed with the Insomnia Severity Index (ISI), and circadian rhythm was assessed using a wrist-worn actiwatch. RESULTS: Community staff interveners delivered 72% of the intervention components, with a recruitment rate of 77% and an adherence rate of 73%, meeting acceptability and feasibility benchmarks. Those randomised to BBT-CI improved their ISI scores by 6.3 points compared to a 2.5-point improvement in those randomised to HEAL (P = 0.041). Actigraphy data indicated that circadian functioning improved in the BBT-CI arm as compared to the HEAL arm at post-intervention (all P-values <0.05). CONCLUSIONS: BBT-CI is an acceptable and feasible intervention that can be delivered directly in the community oncology setting by trained staff. The BBT-CI arm experienced significant improvements in insomnia and circadian rhythm as compared to the control condition.

Oral curcumin for radiation dermatitis: a URCC NCORP study of 686 breast cancer patients.

PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancer patients. Patients took four 500-mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until 1 week post-RT. RESULTS: A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed-model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) = 0.044 (- 0.101, 0.188), p = 0.552). Fewer curcumin patients with RDS > 3.0 suggested a trend toward reduced severity (7.4 vs. 12.9%, p = 0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS: Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.

Racial Differences in Information Needs During and After Cancer Treatment: a Nationwide, Longitudinal Survey by the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program.

Before treatment, cancer patients need information about side effects and prognosis, while after treatment they need information to transition to survivorship. Research documenting these needs is limited, especially among racial and ethnic minorities. This study evaluated cancer patients' needs according to race both before and after treatment. We compared white (n = 904) to black (n = 52) patients receiving treatment at 17 National Cancer Institute Community Oncology Research Program (NCORP) sites on their cancer-related concerns and need for information before and after cancer treatment. Two-sample t test and chi-squared analyses were used to assess group differences. Compared to white patients, black patients reported significantly higher concerns about diet (44.3 vs. 25.4 %,) and exercise (40.4 vs. 19.7 %,) during the course of treatment. Compared to whites, blacks also had significantly higher concern about treatment-related issues (white vs. black mean, 25.52 vs. 31.78), self-image issues (7.03 vs. 8.60), family-related issues (10.44 vs. 12.84), and financial concerns (6.42 vs. 8.90, all p < 0.05). Blacks, compared to whites, also had significantly greater post-treatment information needs regarding follow-up tests (8.17 vs. 9.44), stress management (4.12 vs. 4.89), and handling stigma after cancer treatment (4.21 vs. 4.89) [all p < 0.05]. Pre-treatment concerns and post-treatment information needs differed by race, with black patients reporting greater information needs and concerns. In clinical practice, tailored approaches may work particularly well in addressing the needs and concerns of black patients.

Bundling of Reimbursement for Inferior Vena Cava Filter Placement Resulted in Significantly Decreased Utilization between 2012 and 2014.

BACKGROUND: On January 1, 2012, reimbursement for inferior vena cava filters (IVCFs) became bundled by the Centers for Medicare and Medicaid Services. This resulted in ICVF placement (CPT code 37191) now yielding 4.71 relative value units (RVUs), a decrease from 15.6 RVUs for placement and associated procedures (CPT codes 37620, 36010, 75825-26, 75940-26). Our hypothesis was that IVCF utilization would decrease in response to this change as other procedures had done once they had become bundled. METHODS: Including data from 2010 to 2011 (before bundling) and 2012 to 2014 (after bundling), we utilized 5% inpatient, outpatient, and carrier files of Medicare limited data sets and analyzed IVCF utilization before and after bundling across specialty types, controlling for total diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE) (ICD-9 codes 453.xx and 415.xx, respectively) and placement location. RESULTS: In 2010 and 2011, the rates/10,000 DVT/PE diagnoses were 918 and 1,052, respectively (average 985). In 2012, 2013, and 2014, rates were 987, 877, and 605, respectively (average 823). Comparing each year individually, there is a significant difference (P < 0.0001) with 2012, 2013, and 2014 having lower rates of ICVF utilization. Comparing averages in the 2010-2011 and 2012-2014 groups, there is also a significant decrease in utilization after bundling (P < 0.0001). CONCLUSIONS: Following the bundling of reimbursement for IVCF placement, procedural utilization decreased significantly. More data from subsequent years will be needed to show if this decrease utilization continues to persist.

Hearing function in patients living with HIV/AIDS.

OBJECTIVES: During the earlier years of the HIV/AIDS epidemic, initial reports described sensorineural hearing loss in up to 49% of individuals with HIV/AIDS. During those years, patients commonly progressed to advanced stages of HIV disease and frequently had neurological complications. However, the abnormalities on pure-tone audiometry and brainstem-evoked responses outlined in small studies were not always consistently correlated with advanced stages of HIV/AIDS. Moreover, these studies could not exclude the confounding effect of concurrent opportunistic infections and syphilis. Additional reports also have indicated that some antiretroviral medications may be ototoxic; thus, it has been difficult to make conclusions regarding the cause of changes in hearing function in HIV-infected patients. More recently, accelerated aging has been suggested as a potential explanation for the disproportionate increase in complications of aging described in many HIV-infected patients; hence, accelerated aging-associated hearing loss may also be playing a role in these patients. DESIGN: We conducted a large cross-sectional analysis of hearing function in over 300 patients with HIV-1 infection and in 137 HIV-uninfected controls. HIV-infected participants and HIV-uninfected controls underwent a 2-hr battery of hearing tests including the Hearing Handicap Inventory, standard audiometric pure-tone air and bone conduction testing, tympanometric testing, and speech reception and discrimination testing. RESULTS: Three-way analysis of variance (ANOVA) and logistic regression analysis of 278 eligible HIV-infected subjects stratified by disease stage in early HIV disease (n = 127) and late HIV disease (n = 148) and 120 eligible HIV-uninfected controls revealed no statistically significant differences among the three study groups in either overall 4-frequency pure-tone average (4-PTA) or hearing loss prevalence in either ear. Three-way ANOVA showed significant differences in word recognition scores in the right ear among groups, a significant group effect on tympanogram static admittance in both ears and a significant group effect on tympanic gradient in the right ear. There was significantly larger admittance and gradient in controls as compared to the HIV-infected group at late stage of disease. Hearing loss in the HIV-infected groups was associated with increased age and was similar to that described in the literature for the general population. Three-way ANOVA analysis also indicated significantly greater pure-tone thresholds (worse hearing) at low frequencies in HIV patients in the late stage of disease compared with HIV-uninfected controls. This difference was also found by semi-parametric mixed effects models. CONCLUSIONS: Despite reports of "premature" or "accelerated" aging in HIV-infected subjects, we found no evidence of hearing loss occurring at an earlier age in HIV-infected patients compared to HIV-uninfected controls. Similar to what is described in the general population, the probability of hearing loss increased with age in the HIV-infected subjects and was more common in patients over 60 years of age. Interestingly, HIV-infected subjects had worse hearing at lower frequencies and have significant differences in tympanometry compared to HIV-uninfected controls; these findings deserve further study.

Understanding sociodemographic and sociocultural factors that characterize tobacco use and cessation during pregnancy among women in the Dominican Republic.

Tobacco use and exposure are serious public health problems that threaten to undermine improvements in maternal and child health, and add to already existing poor pregnancy outcomes in many low- and middle-income countries. The purpose of this study is to explore factors that characterize tobacco use and cessation during pregnancy among women in the Dominican Republic. This study was part of a larger trial and includes a sample of women who participated in baseline surveillance and community assessments (n = 613). Descriptive, bivariate, and multivariable analyses were conducted. Overall, 93.31 % (n = 572) of women experienced a past/current pregnancy and 22.44 % (n = 127) smoked during a past or current pregnancy. Among women who had smoked, 34.13 % (n = 43) stopped smoking due to a pregnancy, and 46.03 % (n = 58) were advised by a health care provider to quit smoking because of pregnancy. Women who were older, Catholic, and had a mother who used tobacco were three times more likely to smoke during a past or current pregnancy. Inability to read or write was also significantly associated with smoking during pregnancy. Women who were able to read and write and were from a tobacco growing community were three times more likely to quit smoking during pregnancy. This study provides a preliminary understanding of factors influencing tobacco use and cessation among pregnant women in the Dominican Republic. It also informs a critical area for public health research and intervention, indicating opportunities to engage the health care provider community in intervening with pregnant women and their families.

Adapting the pregnancy risk assessment monitoring survey to enhance locally available data: methods.

Despite the increasing emphasis on pre- and interconception planning, perinatal data available to local municipalities and organizations is often limited to that on the birth certificate. A partnership between a local health department and an academic medical center sought to overcome this gap. Using the core questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) and a stratified random sample methodology (by income) in a county with ~8,000 annual births we mailed 2,462 surveys to mothers who gave birth between May 2009 and April 2010. Mailings occurred at 4-5 months postpartum. Low income mothers (those with a Medicaid-funded delivery and/or prenatal WIC enrollment) were oversampled based on a projected response rate of 35% (rate for non-low income was 55%). Over 1,000 usable surveys were returned and linked with birth certificate data. Target response rates were achieved. 9.4% of addresses for low income mothers were undeliverable (vs. 4.2% of non-low income). Both low and non-low income respondents were more likely to be over age 18 and White. After statistical adjustments the survey dataset was demographically similar to the original birth data. Personnel and non-personnel costs per usable survey exceeded $20. Collecting local data using a modified PRAMS methodology is feasible but requires expertise in survey, data management and birth certificate data and local knowledge about survey response patterns. These types of data can serve to inform policy and program planning and provide data to support relevant funding requests.

Cohort study of smoke-free homes in economically disadvantaged communities in the Dominican Republic.

OBJECTIVE: To analyze household smoking-ban prevalence over time and predictors among communities in the Dominican Republic, historically a significant tobacco-growing country with few tobacco control regulations. METHODS: Baseline (2004) and follow-up surveillance surveys (2006, 2007) (each n > 1 000 randomly selected households) conducted in six economically disadvantaged communities (three tobacco-growing and two each urban, peri-urban, and rural) assessed household members' demographics, health status, and household characteristics, including smoking restrictions. RESULTS: Between 2004 and 2007, household smoking-ban prevalence increased in all communities, with overall rates increasing from 23.9% (2004) to 45.3% (2007). Households with smokers adopted smoking bans at lower rates (6%-17%) versus those without smokers (which had an adoption rate of 35%-58%). Logistic regression models demonstrated that the associations between allowing smoking in households with no members who smoked and being located in a tobacco-growing community, being a Catholic household, and having a member with a cardiovascular problem were statistically significant. The association between having a child under age 5 or a member with a respiratory condition and prohibiting smoking in the home was not statistically significant. CONCLUSIONS: Prevalence of households banning smoking increased in all communities but remained well below rates in industrialized countries. For low- and middle-income countries or those in early stages of tobacco control, basic awareness-raising measures (including surveillance activities) may lead to statistically significant increases in household smoking-ban adoption, particularly among households with no smokers. An increase in household smoking-ban prevalence may result in changes in community norms that can lead to a further increase in the adoption of smoking bans. Having household members who smoke and being in a tobacco-growing community may mitigate the establishment of household bans. Increasing individuals' knowledge about the far-reaching health effects of secondhand smoke exposure on children and nonsmoking adults (healthy or unhealthy) may help overcome these obstacles.

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial.

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30 to 60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor-blinded randomized clinical trial (RCT) was designed to assess 1) preliminary efficacy (ie, alpha pre-specified at .2) of a wearable, app-controlled, transcutaneous electrical nerve stimulation (TENS) device for chronic CIPN and 2) feasibility of conducting a confirmatory trial within the National Cancer Institute Community Oncology Research Program (NCORP) (NCT04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0-10 numeric rating scales). The primary analysis was an analysis of covariance (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used a similar analysis of covariance models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at the endpoint (placebo-active) was 1.05 (95% Confidence Interval: -.56, 2.67; P = .199). The difference between groups for the individual symptoms was as follows: hot/burning pain: 1.37 (-.33, 3.08; P = .112), sharp/shooting pain: 1.21 (-.37, 2.79; P = .128), cramping: 1.35 (-.32, 3.02; P = .110), tingling: .23 (-.61, 1.08; P = .587), numbness: .27 (-.51, 1.05; P = .492). An RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in the NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PERSPECTIVE: Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.

A Whole Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Feasibility, Nutrient, and Patient-Reported Outcomes.

Purpose: Quality of life (QOL) is among the most important outcomes for women with metastatic breast cancer (MBC) and it predicts survival. QOL is negatively impacted by cognitive impairment, fatigue, and weight gain. We assessed whether a whole food, plant-based (WFPB) diet promoting weight loss is feasible and might improve QOL. Methods: Women with MBC on stable systemic treatments were randomized 2:1 to 1) WFPB dietary intervention (n = 21) or 2) usual care (n = 11) for 8 weeks. Participants attended weekly education visits and consumed an ad libitum WFPB diet (3 prepared meals/day provided). Patient-reported outcomes and 3-day food records were assessed at baseline and 8 weeks. The effects of WFPB diet on changes in outcomes were assessed by analysis of covariance model controlling for baseline. Results: 20 intervention and 10 control participants completed the trial. Intervention participants were highly adherent to the WFPB diet (94.3% total calories on-plan). Intervention group nutrient intakes changed significantly including dietary fat (35.8-20.4% percent calories from fat, p < 0.001) and fiber content (22.1 to 40.8 grams fiber/1000 kcal, p < 0.001). Perceived cognitive function (FACT-Cog total + 16.1; 95% confidence interval [CI] = 0.8-31.7; p = 0.040) and emotional well-being (FACT-B emotional well-being subscale + 2.3; CI = 0.5-4.1; p = 0.016) improved in the WFPB versus the control group. Fatigue, measured by the BFI, improved within the WFPB group for fatigue severity (M = 4.7 ± 2.5[SD] to 3.7 ± 2.3, p = 0.047) and fatigue at its worst (5.8 ± 2.8 to 4.4 ± 2.4, p = 0.011). Conclusions: Significant dietary changes in this population are feasible and may improve QOL by improving treatment-related symptoms. Additional study is warranted. Trial registration: ClinicalTrials.gov identifier: NCT03045289. Registered 7 February 2017.

A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome.

Purpose: Breast cancer treatment is associated with weight gain, and obesity and its related cardiometabolic and hormonal risk factors have been associated with poorer outcomes. Dietary intervention may address these risk factors, but limited research has been done in the setting of metastatic breast cancer requiring systemic therapy. Methods: Women with metastatic breast cancer on stable treatment were randomized 2:1 to an 8-week intervention (n = 21) or control (n = 11). The intervention included weekly assessment visits and an ad libitum whole food, plant-based (WFPB) diet with provided meals. Cardiometabolic, hormonal, and cancer markers were assessed at baseline, 4 weeks, and 8 weeks. Results: Within the intervention group, mean weight decreased by 6.6% (p < 0.01) after 8 weeks. Fasting insulin decreased from 16.8 uIU/L to 11.2 uIU/L (p < 0.01), concurrent with significantly reduced insulin resistance. Total cholesterol decreased from 193.6 mg/dL to 159 mg/dL (p < 0.01) and low-density lipoprotein (LDL) cholesterol decreased from 104.6 mg/dL to 82.2 mg/dL (p < 0.01). Total testosterone was unchanged, but free testosterone trended lower within the intervention group (p = 0.08) as sex hormone binding globulin increased from 74.3 nmol/L to 98.2 nmol/L (p < 0.01). There were no significant differences in cancer progression markers at week 8, although mean CA 15 - 3, CA 27.29, and CEA were lower in the intervention group (p = 0.53, p = 0.23, and p = 0.54, respectively) compared to control, when adjusted for baseline. Conclusion: WFPB dietary changes during treatment for metastatic breast cancer are well tolerated and significantly improve weight and cardiometabolic and hormonal parameters. Longer studies are warranted to assess the durability of changes. Trial registration: First registered at Clinicaltrials.gov (NCT03045289) on February 7, 2017.

Perceived discrimination, psychological distress, and current smoking status: results from the Behavioral Risk Factor Surveillance System Reactions to Race module, 2004-2008.

OBJECTIVES: We examined the association between perceived discrimination and smoking status and whether psychological distress mediated this relationship in a large, multiethnic sample. METHODS: We used 2004 through 2008 data from the Behavioral Risk Factor Surveillance System Reactions to Race module to conduct multivariate logistic regression analyses and tests of mediation examining associations between perceived discrimination in health care and workplace settings, psychological distress, and current smoking status. RESULTS: Regardless of race/ethnicity, perceived discrimination was associated with increased odds of current smoking. Psychological distress was also a significant mediator of the discrimination-smoking association. CONCLUSIONS: Our results indicate that individuals who report discriminatory treatment in multiple domains may be more likely to smoke, in part, because of the psychological distress associated with such treatment.

An epidemiologic transition of cardiovascular disease risk in Carriacou and Petite Martinique, Grenada: the Grenada Heart Project, 2005-2007.

INTRODUCTION: The epidemiologic transition has made chronic disease a major health threat in the Caribbean and throughout the world. Our objective was to examine the pattern of lifestyle factors associated with cardiovascular disease (CVD) in Grenada and to determine whether the prevalence of CVD risk factors differs by subgroups. METHODS: We conducted a cross-sectional study of adult Grenadians between 2005 and 2007. We used a population-wide, community-based approach by adapting the World Health Organization's STEPwise Approach to the Surveillance of Chronic Disease survey for a local context. We collected behavioral, anthropometric, and blood sample data to assess the prevalence of CVD risk factors. RESULTS: An estimated 64% (n = 2,017) of 3,167 eligible adults participated in our study (60% women). With increasing age, consumption of fried foods declined, whereas fish intake increased. Adults aged 45 to 54 years had the highest obesity rate (39%). Large waist circumference was more common among women than among men. According to National Cholesterol Education Program criteria, 29% of participants had metabolic syndrome (47% ≥ 65 y; 36% women vs 17% men). Approximately one-fifth of participants had lived outside Grenada for more than 10 years. Participants who had migrated tended to be older and have different CVD risk factors than those who had never migrated. CONCLUSION: In the midst of an epidemiologic transition in the Caribbean nation of Grenada in which CVD risk is increasing, dietary risk factors are most prevalent among women and among all adults younger than 55.

The outcomes of emergency pharmacist participation during acute myocardial infarction.

BACKGROUND: Current guidelines recommend door-to-balloon times of 90 min or less for patients presenting to the emergency department (ED) with ST-segment elevation myocardial infarction (STEMI). OBJECTIVES: To determine if a clinical pharmacist for the ED (EPh) is associated with decreased door/diagnosis-to-cardiac catheterization laboratory (CCL) time and decreased door-to-balloon time. METHODS: A retrospective observational cohort study of ED patients with STEMI requiring urgent cardiac catheterization was conducted. Blinded data collection included timing of ED and CCL arrival, diagnostic electrocardiogram (ECG), and balloon angioplasty. For cases diagnosed after ED arrival, diagnosis time was substituted for door time. Diagnosis was the time ST elevations were evident on serial ECG. EPh present and not-present groups were compared. During the study period there were two EPhs and presence was determined by their scheduled time in the ED. Univariate and multivariate analyses was used to detect differences. RESULTS: Multivariate analysis of 120 patients, controlled for CCL staff presence and arrival by pre-hospital services, determined that EPh presence is associated with a mean 13.1-min (95% confidence interval [CI] 6.5-21.9) and 11.5-min (95% CI 3.9-21.5) decrease in door/diagnosis-to-CCL and door-to-balloon times, respectively. Patients were more likely to achieve a door/diagnosis-to-CCL time≤ 30 min (odds ratio [OR] 3.1, 95% CI 1.3-7.8) and≤ 45 min (OR 2.9, 95% CI-1.0, 8.5) and a door-to-balloon time≤ 90 min (OR 1.9, 95% CI 0.7-5.5) more likely when the EPh was present. CONCLUSIONS: EPh presence during STEMI presentation to the ED is independently associated with a decrease in door/diagnosis-to-CCL and door-to-balloon times.

Retention of dental sealants placed on sound teeth and incipient caries lesions as part of a service-learning programme in rural areas in Mexico.

BACKGROUND: Dental sealants are an effective treatment for the prevention and management of caries. OBJECTIVE: To determine the retention of sealants placed in a rural setting in Mexico as part of an international service-learning (ISL) programme and to determine associations between dental sealant's retention and caries diagnosis at the time of sealant placement. METHODS: Children aged 6-15 were examined for dental caries, received sealants by dental students as part of an ISL programme, and were re-examined 4, 2, or 1 years after placement to assess sealant survival. Sealants were placed on permanent sound surfaces and enamel caries lesions [International Caries Assessment and Detection System (ICDAS) criteria]. Sealant survival was explored using Cochran-Mantel-Haenszel tests and multivariate prediction models. RESULTS: 219 (46%) of 478 (mean age = 10.53 SD = 5.11) children who had received sealants returned for a recall examination (mean age = 10.89 SD = 3.11). After 1-4 years, 96.4% to 60.6% of the sealants placed on sound teeth had survived, and for sealants placed on surfaces with enamel caries lesions (ICDAS 1-3), 94.2% to 55.6% had survived. Differences were not statistically significant. CONCLUSIONS: Sealants had survival rates comparable to those previously reported in the literature. Sealants placed on sound and enamel caries lesions had similar survival rates.

Tobacco use and exposure to secondhand smoke among pregnant women in the Dominican Republic: an exploratory look into attitudes, beliefs, perceptions, and practices.

INTRODUCTION: The purpose of this study is to assess the attitudes, beliefs, perceptions, and practices regarding tobacco use and exposure among pregnant women in the Dominican Republic. METHODS: The survey was conducted in two public health hospitals in Santiago, Dominican Republic, and was administered to a convenience sample of 192 women during prenatal care visits. Analyses examined pregnant women's tobacco use, secondhand smoke exposure (SHS), knowledge about risks of smoking and benefits of quitting, and attitudes toward women's tobacco use. All data were collected between April and August 2009. RESULTS: Respondents' age ranged from 18 to 41 years, with a mean age of 25 years (SD = 4.59), a high literacy level (82%), low educational levels (48% less than high school education), and a high unemployment rate (65%). Levels of ever having experimented with cigarettes were 14%, and 5% had ever been a regular smoker. Among all respondents, 3% of women reported being current smokers. When respondents were asked if they would try smoking next year, 7% responded yes, maybe, or don't know. Rates of self-reported SHS among pregnant women were 16%, and 14% reported their young children being exposed to secondhand smoke. More than half of the pregnant women in this study allowed smoking in their home (76%). CONCLUSIONS: This study provides a preliminary understanding of tobacco use and exposure among pregnant women and its potential impact on the Dominican Republic's public health efforts that include improving maternal and child health.