A Perspective Review on Diet Quality, Excess Adiposity, and Chronic Psychosocial Stress and Implications for Early-Onset Colorectal Cancer.

Colorectal cancer (CRC) is the third most common cancer worldwide. Although the overall incidence of CRC has been decreasing over the past 40 y, early-onset colorectal cancer (EOCRC), which is defined as a CRC diagnosis in patients aged >50 y has increased. In this Perspective, we highlight and summarize the association between diet quality and excess adiposity, and EOCRC. We also explore chronic psychosocial stress (CPS), a less investigated modifiable risk factor, and EOCRC. We were able to show that a poor-quality diet, characterized by a high intake of sugary beverages and a Western diet pattern (high intake of red and processed meats, refined grains, and foods with added sugars) can promote risk factors associated with EOCRC development, such as an imbalance in the composition and function of the gut microbiome, presence of chronic inflammation, and insulin resistance. Excess adiposity, particularly obesity onset in early adulthood, is a likely contributor of EOCRC. Although the research is sparse examining CPS and CRC/EOCRC, we describe likely pathways linking CPS to tumorigenesis. Although additional research is needed to understand what factors are driving the uptick in EOCRC, managing body weight, improving diet quality, and mitigating psychosocial stress, may play an important role in reducing an individual's risk of EOCRC.

A feasibility study of breast cancer genetic risk assessment in a federally qualified health center.

BACKGROUND: The US Preventive Services Task Force (USPSTF) endorses routine screening for genetic risk of breast and/or ovarian cancer as a component of primary health care. Implementation of this recommendation may prove challenging, especially in clinics serving disadvantaged communities. METHODS: The authors tested the feasibility of implementing the USPSTF mandate at a federally qualified health center (FQHC) to identify women who were eligible for genetic counseling (GC). A 12-month usual-care phase was followed by a 12-month intervention phase, during which time cancer genetic risk assessment (CGRA) was systematically performed for all women aged 25 to 69 years who presented for an annual examination. Women who were eligible for GC were recruited to participate in the study. RESULTS: After initiating CGRA, 112 women who were eligible for GC consented to study participation, and 56% of them received a referral for GC from their primary care physician. A subgroup of 50 participants were seen by the same primary care physician during both the usual-care and intervention phases. None of these patients was referred for GC during usual care, compared with 64% after the initiation of CGRA (P < .001). Only 16% of referred participants attended a GC session. CONCLUSIONS: Implementing USPSTF recommendations for CGRA as a standard component of primary health care in FQHCs is feasible and improves referral of minority women for GC, but more work is needed to understand the beliefs and barriers that prevent many underserved women from accessing cancer genetic services.

Design of a Remote Time-Restricted Eating and Mindfulness Intervention to Reduce Risk Factors Associated with Early-Onset Colorectal Cancer Development among Young Adults.

Early-onset colorectal cancer (EOCRC) is defined as a diagnosis of colorectal cancer (CRC) in individuals younger than 50 years of age. While overall CRC rates in the United States (US) decreased between 2001 and 2018, EOCRC rates have increased. This research project aims to evaluate the feasibility and acceptability of Time-Restricted Eating (TRE), Mindfulness, or TRE combined with Mindfulness among young to middle-aged adults at risk of EOCRC. Forty-eight participants will be randomly assigned to one of four groups: TRE, Mindfulness, TRE and Mindfulness, or Control. Data on feasibility, adherence, and acceptability will be collected. Measures assessed at baseline and post-intervention will include body weight, body composition, dietary intake, physical activity, sleep behavior, circulating biomarkers, hair cortisol, and the gut microbiome. The effects of the intervention on the following will be examined: (1) acceptability and feasibility; (2) body weight, body composition, and adherence to TRE; (3) circulating metabolic, inflammation, and oxidative stress biomarkers; (4) intestinal inflammation; and (5) the gut microbiome. TRE, combined with Mindfulness, holds promise for stress reduction and weight management among individuals at risk of EOCRC. The results of this pilot study will inform the design and development of larger trials aimed at preventing risk factors associated with EOCRC.

Design of a Mindfulness intervention to reduce risk factors for colorectal cancer among at-risk Black women in Chicago.

Chronic stress can directly and indirectly promote carcinogenesis through immune, metabolic, and microbial pathways. Our overarching hypothesis is that reducing chronic stress will have important implications for colorectal cancer (CRC) risk reduction among vulnerable and high-risk populations. A promising approach for reducing chronic stress is Mindfulness. Mindfulness is a meditation-based technique that achieves a state of mind that is used to experience higher awareness or consciousness. Existing small studies suggest Mindfulness can positively regulate stress response in a way that translates to anti-cancer effects, including reduced systemic inflammation. We propose to evaluate an 8-week Mindfulness intervention delivered in a hybrid format (synchronous and asynchronous sessions) among 40 Black women at elevated risk of CRC who reside in vulnerable communities and who report moderate to high perceived stress. At baseline and post-intervention, participants will provide blood, hair, and stool, undergo body composition analysis, and complete mood and lifestyle-related surveys. The specific aims are to assess the feasibility and acceptability of the intervention and explore changes on stress, weight, fasting glucose, inflammation markers, and the gut microbiota - risk markers and risk pathways associated with CRC. The data generated through this project will inform if Mindfulness is a feasible option for CRC risk reduction among high-risk individuals.

Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. Objective: To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. Design, Setting, and Participants: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. Interventions: The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Main Outcomes and Measures: Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Results: Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT02990299.

Association between sleep hygiene practices scale and sleep quality in Black and Latinx patients with uncontrolled type 2 diabetes.

Objective: We explored the relationship between the Sleep Hygiene Practices Scale (SHPS) and sleep quality and sleep-related impairment in Black and Latinx adults with type 2 diabetes (T2DM). Methods: Forty Black and Latinx adults with T2DM participated. Self-reported measures include the Pittsburg Sleep Quality Index (PSQI), Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) measures, and SHPS (domains include sleep schedule and timing, arousal-related behaviors, poor eating/drinking habits prior to sleep, and poor sleep environment). Results: SHPS Cronbach's alpha coefficients were 0.58 (schedule), 0.78 (arousal), 0.29 (eating), 0.81 (environment) and 0.88 (overall for four domains). SHPS scores correlated with PSQI (Pearson correlation r = 0.67, 95% CI [0.44, 0.81], PROMIS-SD (r = 0.61 [0.36-0.77]), and PROMIS-SRI (r = 0.43, [0.13-0.65]). There remained a significant relationship between sleep hygiene and both sleep quality and sleep-related impairment adjusting for hemoglobin A1c, age, and body mass index in regression models. Conclusions: We observed moderate correlations between sleep quality and sleep-related impairment with sleep hygiene using the SHPS in Black and Latinx adults with T2DM.

A Pharmacist and Health Coach-Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study.

BACKGROUND: Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. OBJECTIVE: The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach-delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. METHODS: A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. RESULTS: Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. CONCLUSIONS: This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17170.

Feasibility of text message sleep assessment in African American and Latino patients with type 2 diabetes.

STUDY OBJECTIVES: Text messaging (TM) may provide an inexpensive and convenient method for self-reported sleep assessment. This pilot study evaluated the feasibility of a TM sleep diary among a racial/ethnic minority population with uncontrolled type 2 diabetes. METHODS: A convenience sample of 40 participants with uncontrolled type 2 diabetes was recruited. Participants wore an Actiwatch (Philips Spectrum Plus, Philips Respironics, Murrysville, Pennsylvania) for 7 consecutive days during both wake and sleep intervals and completed a daily TM sleep diary including 10 questions adapted from the Consensus Sleep Diary. The relationships between sleep measures from TMs and actigraphy were explored through Bland-Altman plots and correlations. RESULTS: Of the 40 participants enrolled, 34 were African American and 6 were Latino. The mean age was 52.2 years (standard deviation = 8.2), and the mean hemoglobin A1c was 9.0% (standard deviation = 1.5). All but 1 participant attempted to complete the TM sleep diary. With a maximum of 70 TM replies possible, the median number of responses per participant was 66 (interquartile range = 59.5-69). Actigraphy and TM measures were related for total sleep time (median = 382 vs 393 min, respectively [r = .71; P < .01]), sleep onset latency (median = 31.4 vs 27.5 min [r = .61; P < .01]), time in bed (433.3 vs 489.3 min [r = .74; P < .01]), and sleep efficiency (77% vs 86% [r = .45; P = .005]). The measure of wake after sleep onset was higher from actigraphy than from TM, with a weak relationship between the 2 measures (median 47.9 vs 6.0 min [r = .31; P = .05]). CONCLUSIONS: TM is a novel and feasible method for sleep assessment in racial/ethnic minority adults with uncontrolled type 2 diabetes.

Promoting Mindfulness in African American Communities.

African Americans report higher rates of chronic stress compared to non-Hispanic Whites. Consequently, chronic stress contributes to disproportionately higher rates of poor health outcomes among African Americans. Mindfulness meditation is a well-established and studied strategy to reduce stress and potentially improve health outcomes. However, the practice of mindfulness meditation is largely underutilized in African American communities despite its potential health benefits. In this commentary, we will discuss the relevance of mindfulness interventions, limited research available, reasons for low representation, and cultural adaptations for mindfulness meditation in African American communities. We also provide additional strategies to guide future mindfulness research that target African Americans.

Relationship between depression, sleep quality, and hypoglycemia among persons with type 2 diabetes.

OBJECTIVE: We analyzed two cohorts of people with type 2 diabetes to evaluate the relationships between depression, sleep quality, and history of hypoglycemia. RESEARCH DESIGN AND METHODS: Two adult cohorts from Chicago (n = 193) and Bangkok, Thailand (n = 282) with type 2 diabetes completed questionnaires to assess sleep quality, depressive symptoms, and hypoglycemia frequency. Proportional odds logistic regression models for each cohort adjusted for duration of therapy, insulin and sulfonylurea management, and other factors. RESULTS: Those with hypoglycemia in both cohorts had a longer duration of diabetes, greater use of insulin, and worse sleep quality. The Chicago cohort used less sulfonylureas but had higher depressive symptom scores. The Thailand cohort had greater sulfonylurea use. In the final Thailand regression model, depressive symptoms were independently associated with hypoglycemia frequency. In both final Chicago and Thailand models, sleep quality was not associated with hypoglycemia frequency. CONCLUSIONS: In the Thailand cohort, depressive symptoms were associated with hypoglycemia frequency.

Medicare D Subsidies and Racial Disparities in Persistence and Adherence With Hormonal Therapy.

Purpose To investigate the role of out-of-pocket cost supports through the Medicare Part D Low-Income Subsidy on disparities in breast cancer hormonal therapy persistence and adherence by race or ethnicity. Methods A nationwide cohort of women age ≥ 65 years with a breast cancer operation between 2006 and 2007 and at least one prescription filled for oral breast cancer hormonal therapy was identified from all Medicare D enrollees. The association of race or ethnicity with nonpersistence (90 consecutive days with no claims for a hormonal therapy prescription) and nonadherence (medication possession rate < 80%) was examined. Survival analyses were used to account for potential differences in age, comorbidity, or intensity of other treatments. Results Among the 25,111 women in the study sample, 77% of the Hispanic and 70% of the black women received a subsidy compared with 21% of the white women. By 2 years, 69% of black and 70% of Hispanic patients were persistent compared with 61% of white patients. In adjusted analyses, patients in all three unsubsidized race or ethnicity groups had greater discontinuation than subsidized groups (white patients: hazard ratio [HR], 1.83; 95% CI, 1.70 to 1.95; black patients: HR, 2.09; 95% CI, 1.73 to 2.51; Hispanic patients: HR, 3.00; 95% CI, 2.37 to 3.89). Racial or ethnic persistence disparities that were present for unsubsidized patients were not present or reversed among subsidized patients. All three subsidized race or ethnicity groups also had higher adherence than all three unsubsidized groups, although with the smallest difference occurring in black women. Conclusion Receipt of a prescription subsidy was associated with substantially improved persistence to breast cancer hormonal therapy among white, black, and Hispanic women and lack of racial or ethnic disparities in persistence. Given high subsidy enrollment among black and Hispanic women, policies targeted at low-income patients have the potential to also substantially reduce racial and ethnic disparities.

Translating a plan into action: a Public Health Action Plan to Prevent Heart Disease and Stroke.

A Public Health Action Plan to Prevent Heart Disease and Stroke charts a course for the Centers for Disease Control and Prevention (CDC) and collaborating public health agencies, with all interested partners and the public at large, to help in promoting achievement of national goals for preventing heart disease and stroke over the next 2 decades--through 2020 and beyond. The Action Plan was released in April 2003 and includes 24 recommendations and 69 proposed action steps to be implemented now and in the years ahead. To set priorities for action and to define a limited set of concrete tasks for immediate implementation, a process was undertaken that included CDC and lead partners, the American Heart Association/American Stroke Association and Association of State and Territorial Health Officials, as well as the Action Plan Working Group and other members of the National Forum for Heart Disease and Stroke Prevention. This report presents details of the methods used and discussion of this process and its outcome. The process was facilitated by Concept Systems, Inc. and began with refinement of proposed action steps to yield a final list of 75 items. Next, the Action Plan Working Group and the full National Forum membership were invited to rate each proposed action step as to its relation to the mission and capacity of the organization represented by each respondent. This process, with review and discussion of results by the Working Group in January 2004, identified a subset of 22 priority action steps. The National Forum then met in April 2004 to discuss these priorities and ultimately adopted eight concrete tasks for immediate implementation.

The introduction of generic aromatase inhibitors and treatment adherence among Medicare D enrollees.

BACKGROUND: Aromatase inhibitors (AIs) substantially reduce breast cancer mortality in clinical trials, but high rates of nonadherence to these long-term oral therapies have reduced their impact outside of trials. We examined the association of generic AI availability with AI adherence among a large national breast cancer cohort. METHODS: Using a quasi-experimental prepost design, we examined the effect of generic AI introductions (7/2010 and 4/2011) on adherence among a national cohort of women with incident breast cancer in 2006 and 2007 who were enrolled in the Medicare D pharmaceutical coverage program. Medicare D claims were used to calculate AI adherence, defined as a medication possession ratio of 80% or more of eligible days, over 36 months. Multivariable logistic regression models estimated with generalized estimating equations were applied to longitudinal adherence data to control for possible confounders, including receipt of a Medicare D low-income subsidy, and to account for repeated measures. All statistical tests were two-sided. RESULTS: Sixteen thousand four hundred sixty-two Medicare D enrollees were eligible. Adherence declined throughout the study. However, among women without a subsidy, the median quarterly out-of-pocket cost of anastrozole fell from $183 in the fourth quarter of 2009 to $15 in 2011, and declines in adherence were attenuated with generic AI introductions. Regression-adjusted adherence probabilities were estimated to be 5.4% higher after generic anastrozole was introduced in 2010 and 11% higher after generic letrozole/exemestane was introduced in 2011. Subsidy recipients had higher adherence rates throughout the study. CONCLUSIONS: The introduction of generic medications attenuated the decline in adherence to AIs over three years of treatment among breast cancer survivors not receiving low-income subsidies for Medicare D coverage.