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Purpose: There are multiple treatment options for patients with metastatic breast cancer (MBC); however, there is minimal data on the optimal sequencing. Furthermore, limited information is available to understand the influence of prior treatment duration and class on novel therapies in real-world settings, such as cyclin-dependent kinase 4/6 inhibitors (CDK 4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2- negative (HR+ HER2-) MBC. Our study sought to identify the effect of prior treatments on post-CDK 4/6i survival. Methods: This retrospective study used the nationwide, de-identified electronic health record-derived Flatiron Health database of women with HR+ HER2- MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between duration and class of all cancer treatments prior to receipt of CDK 4/6i and overall survival (OS) adjusting for age at diagnosis, race and ethnicity, site of metastasis, and metastatic diagnosis year. Time dependent HRs were used to compare the OS for patients receiving one versus multiple CDK 4/6i. Results: Of 5,363 patients, most were aged 55-64 (29%), White (69%), and had visceral metastasis (70%). The median survival from receipt of first CDK 4/6 inhibitor was 3.3 years. When compared to patients with no prior treatments, patients with up to one year of prior treatments had a 30% increased hazard of death ((HR, 1.30; 95% CI 1.15-1.46; Table 1). Similarly, patients with one to less than three years of prior treatment had a 68% increased hazard of death (HR 1.68; 95% CI 1.49-1.88) and those with three or more years had a 55% increased hazard of death (HR 1.55; 95% CI 1.36-1.76). Furthermore, patients who received prior endocrine therapy alone experienced a 29% increased hazard of death (HR, 1.29; 95% CI 1.16-1.44), while patients receiving prior chemotherapy experienced a 72% increased hazard of death (HR, 1.72; 95% CI 1.54-1.93) when compared with patients who did not receive a prior treatment. Finally, patients who received a different CDK 4/6i after their first had a 17% decreased hazard of death compared to patients who received subsequent endocrine or chemotherapy after their first CDK 4/6i (HR, 0.83; 95% CI 0.71-0.96). Conclusion: Prior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. However, patients receiving more than one CDK 4/6 inhibitor in their sequence saw survival benefits. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when reporting results of future studies. Table 1: The association between OS and treatment duration and class before CDK 4/6 Citation Format: Jeffrey Franks, Nicole E. Caston, Ahmed Elkhanany, Travis Gerke, Andres Azuero, Gabrielle B. Rocque. Effect of prior treatments on post-CDK 4/6 inhibitor overall survival in hormone receptor positive breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-20.

Purpose Multiple treatment options exist for patients with metastatic breast cancer (MBC). However, limited information is available on the impact of prior treatment duration and class on survival outcome for novel therapies, such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ HER2−) MBC. Methods This study used a nationwide, de-identified electronic health record-derived database to identify women with HR+ HER2− MBC who received at least one CDK 4/6i between 2011 and 2020. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated for the association between prior duration and class of cancer treatment (both early-stage and metastatic) and prior CDK 4/6i survival as well as for those with multiple CDK 4/6i. Results Of 5363 patients, the median survival from first CDK 4/6 inhibitor administration was 3.3 years. When compared to patients with no prior treatments, patients with Conclusion Prior treatment duration and class are associated with a decreased overall survival after CDK 4/6 inhibitor administration. This highlights the importance for clinicians to consider prior treatment and duration in treatment decision-making and for trialists to stratify by these factors when randomizing patients or reporting results of future studies.

Context Patients with advanced cancer often involve family caregivers in health-related decision-making from diagnosis to end-of-life; however, few interventions have been developed to enhance caregiver decision support skills. Objectives Assess the feasibility, acceptability, and potential efficacy of individual intervention components of CASCADE (CAre Supporters Coached to be Adept DEcision Partners), an early telehealth, palliative care coach-led decision support training intervention for caregivers. Methods Pilot factorial trial using the multiphase optimization strategy (October 2019-October 2020). Family caregivers and their care recipients with newly-diagnosed advanced cancer (n = 46 dyads) were randomized to1 of 8 experimental conditions that included a combination of one of the following three CASCADE components: 1) effective decision support psychoeducation; 2) decision support communication training; and 3) Ottawa Decision Guide training. Feasibility was assessed by completion of sessions and questionnaires (predefined as ≥80%). Acceptability was determined through postintervention interviews and participants’ ratings of their likelihood to recommend. Measures of effective decision support and caregiver and patient distress were collected at Twelve and Twenty four weeks. Results Caregiver participants completed 78% of intervention sessions and 81% of questionnaires; patients completed 80% of questionnaires. Across conditions, average caregiver ratings for recommending the program to others was 9.9 on a scale from 1-Not at all likely to 10-Extremely likely. Individual CASCADE components were observed to have potential benefit for effective decision support and caregiver distress. Conclusion We successfully piloted a factorial trial design to examine components of a novel intervention to enhance the decision support skills of advanced cancer family caregivers. A fully-powered factorial trial is warranted. Key Message We pilot tested components of CASCADE, an early palliative care decision support training intervention for family caregivers of patients with advanced cancer. CASCADE components were acceptable and the trial design feasible, providing promising future directions for palliative care intervention development and testing. Pilot results will inform a fully-powered trial.

The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188).This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks.Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants.The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising.To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.

Background Given the high risk of COVID‐19 mortality, patients with cancer may be vulnerable to fear of COVID‐19, adverse psychological outcomes, and health care delays. Methods This longitudinal study surveyed the pandemic's impact on patients with cancer (N= 1529) receiving Patient Advocate Foundation services during early and later pandemic. Generalized estimating equation with repeated measures was conducted to assess the effect of COVID‐19 on psychological distress. Logistic regression with repeated measures was used to assess the effect of COVID‐19 on any delays in accessing health care (e.g., specialty care doctors, laboratory, or diagnostic testing, etc.). Results Among 1199 respondents, 94% considered themselves high risk for COVID‐19. Respondents with more fear of COVID‐19 had a higher mean psychological distress score (10.21; 95% confidence intervals [CI] 9.38–11.03) compared to respondents with less fear (7.55; 95% CI 6.75–8.36). Additionally, 47% reported delaying care. Respondents with more fear of COVID‐19 had higher percentages of delayed care than those with less (56; 95% CI 39%–72% vs. 44%; 95% CI 28%–61%). These relationships persisted throughout the pandemic. For respondents with a COVID‐19 diagnosis in their household (n = 116), distress scores were similar despite higher delays in care (58% vs. 27%) than those without COVID‐19. Conclusions Fear of COVID‐19 is linked to psychological distress and delays in care among patients with cancer. Furthermore, those who are personally impacted see exacerbated cancer care delays. Timely psychosocial support and health care coordination are critical to meet increased care needs of patients with cancer during the COVID‐19 pandemic., Fear of COVID‐19 is associated with psychological distress and delay in cancer care. Timely psychosocial support and health care coordination are needed to meet increased care needs of patient with cancer during the pandemic.

PURPOSE: The extent to which evidence-based treatments are applied to populations not well represented in early stage breast cancer (EBC) trials remains unknown. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. METHODS: This retrospective cohort study used real-world data to evaluate the intensity (high or low) of EBC chemotherapy by patient characteristics (age, race/ethnicity, presence of comorbidity) denoting clinical trial representation status (well represented, underrepresented, unrepresented) for patients diagnosed from 2011–2020. Odds ratios (OR) from a logistic regression model was used to evaluate the association between receipt of high-intensity chemotherapy and clinical trial representation status characteristics adjusting for cancer stage and subtype. RESULTS: Of 970 patients with EBC, 41% were characterized as well represented, 45% as underrepresented, and 13% as unrepresented in clinical trials. In adjusted models, patients aged ≥ 70 versus 45–69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26–0.60), while those aged < 45 versus 45–69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10–3.01). In predicted estimates, the proportion of patients receiving a high-intensity treatment was 87% for patients aged < 45, 79% for patients aged 45–69, and 60% for patients aged ≥ 70. CONCLUSION: 59% of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity. Widening clinical trial eligibility criteria should be considered to better understand survival outcomes, toxicity effects, and ultimately make evidence-based treatment decisions using a more diverse sample.

Employment is a social determinant of health, and women living with HIV (WLWH) are often underemployed. This correlational study examined the socioeconomic, psychosocial, and clinical factors associated with employment among WLWH (n = 1,357) and women at risk for HIV (n = 560). Descriptive and inferential statistics were used to evaluate factors associated with employment status. Employment was associated (p ≤ .05) with better socioeconomic status and quality of life (QOL), less tobacco and substance use, and better physical, psychological, and cognitive health. Among WLWH, employment was associated (p ≤ .05) with improved adherence to HIV care visits and HIV RNA viral suppression. Using multivariable regression modeling, differences were found between WLWH and women at risk for HIV. Among WLWH, household income, QOL, education, and time providing childcare remained associated with employment in adjusted multivariable analyses (R(2) = .272, p < .001). A better understanding of the psychosocial and structural factors affecting employment is needed to reduce occupational disparities among WLWH.

Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent “bundled” palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as “bundled” treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or replaced or whether there are synergistic or antagonistic interactions between intervention components. Progressing toward palliative care interventions that are effective, efficient, and scalable will require new strategies and novel approaches. One such approach is the Multiphase Optimization Strategy (MOST), a framework informed by engineering principles, that uses a systematic process to empirically identify an intervention comprised of components that positively contribute to desired outcomes under real-life constraints. This article provides a brief overview and application of MOST and factorial trial design in palliative care research, including our insights from conducting a pilot factorial trial of an early palliative care intervention to enhance the decision support skills of advanced cancer family caregivers (Project CASCADE).

Background Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

BACKGROUND: There are multiple issues that arise when researchers focus on and only report “statistical significance” of study findings. An important element that is often not included in reports is a discussion of clinical relevance. OBJECTIVES: The authors address issues related to significance, the use of effect sizes, confidence or credible intervals, and the inclusion of clinical relevance in reports of research findings. METHODS: Measures of magnitude, precision, and relevance such as effect sizes, confidence intervals (CIs), and clinically relevant effects are described in detail. Additionally, recommendations for reporting and evaluating effect sizes and CIs are included. Example scenarios are presented to illustrate the interplay of statistical significance and clinical relevance. RESULTS: there are several issues that may arise when significance is the focus of clinical research reporting. One issue is the lack of attention to nonsignificant findings in published works even though findings demonstrate clinical relevance. Another issue is that significance is interpreted as clinical relevance. As well, clinically relevant results from small sample studies are often not considered for publication, and, thus, findings might not be available for meta-analysis. DISCUSSION: Findings in research reports should address effect sizes and clinical relevance and significance. Failure to publish clinically relevant effects and CIs may preclude the inclusion of clinically relevant studies in systematic reviews and meta-analyses thereby limiting the advancement of evidence-based practice. Several accessible resources for researchers to generate, report, and evaluate measures of magnitude, precision, and relevance are included in this article.

PURPOSE Sequential drug treatments in metastatic breast cancer (MBC) are disparate. Clinical trial data includes limited reporting of treatment context, primarily including the number of prior therapies. This study evaluates the relationship between prior treatment time, prior lines of treatment, and survival using a novel visualization technique coupled with statistical analyses. PATIENTS AND METHODS This retrospective cohort study used a nationwide, de-identified electronic health record–derived database to identify women with hormone receptor–positive, human epidermal growth factor receptor 2–negative MBC diagnosed in 2014 who subsequently received paclitaxel. Images were created, with individual patients represented on the y-axis and time, on the x-axis. Specific treatments were represented by colored bars, with Kaplan-Meier curves overlaying the image. Separate images assessed progression-free survival and overall survival (OS). Hazard ratios (HRs) and 95% CIs from Cox proportional hazards models evaluated the association between prior treatment time and OS. RESULTS Of 234 patients, median survival from first paclitaxel administration was 20 months (interquartile range, 8-53 months). An inverse relationship was observed between OS after paclitaxel and timing of administration. In adjusted models, each year on treatment prior to paclitaxel was associated with a 16% increased hazard of death after paclitaxel (HR, 1.16; 95% CI, 1.05 to 1.29). CONCLUSION OS after a specific treatment is dependent on when a drug is given in the disease context, highlighting the potential for an overall OS benefit to be observed on the basis of treatment timing. Prior time on treatment should be considered as a stratifying factor in randomized trials and a confounding factor when examining survival in observational data.

Background Burdens related to time spent receiving cancer care may be substantial for patients with incurable, life‐limiting cancers such as metastatic breast cancer (MBC). Estimates of time spent on health care are needed to inform treatment‐related decision‐making. Methods Estimates of time spent receiving cancer‐related health care in the initial 3 months of treatment for patients with MBC were calculated using the following data sources: (a) direct observations from a time‐in‐motion quality improvement evaluation (process mapping); (b) cross‐sectional patient surveys; and (c) administrative claims. Average ambulatory, inpatient, and total health care time were calculated for specific treatments which differed by antineoplastic type and administration method, including fulvestrant (injection, hormonal), letrozole (oral, hormonal), capecitabine (oral, chemotherapy), and paclitaxel (infusion, chemotherapy). Results Average total time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on treatment. The greatest time contributions were time spent traveling for care and on inpatient services. Time with providers contributed modestly to total care time. Patients receiving infusion/injection treatments, compared with those receiving oral therapy, spent more time in ambulatory care. Health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents. Conclusion Time spent traveling and receiving inpatient care represented a substantial burden to patients with MBC, with variation in time by treatment type and administration method., In patients with metastatic breast cancer, time spent on health care ranged from 7% to 10% of all days included within the initial 3 months of treatment, depending on type of treatment received and its administration method. The greatest time contributions were time spent traveling for care and on inpatient services, and health care time was higher for patients receiving chemotherapeutic agents compared to those receiving hormonal agents.

Background: Sequential therapeutic options in metastatic breast cancer (MBC) are disparate. However, clinical trial data on treatments received pre- or post-trial are limited to number of prior therapies and not the prior sequence or duration of treatment. The lack of contextual data on prior treatment history in clinical trials may contribute to challenges evaluating efficacy. This study sought to understand the relationship between sequential order of treatments, prior treatment time, and survival using a novel visualization technique and conventional statistics. Methods: This retrospective cohort study utilized the nationwide, de-identified electronic health record (EHR)-derived Flatiron Health database to identify women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) -negative MBC diagnosed in 2014 who subsequently received paclitaxel. Visualizations were created with individual patients represented on the Y-axis and time on the X-axis to qualitatively evaluate treatment patterns and survival. Time 0 was defined as initiation of paclitaxel in the metastatic setting. Specific treatments were represented by a color-coded treatment bar, with post-metastatic paclitaxel in black, hormonal therapy in shades of red, chemotherapy in shades of blue, HER2-targeted therapy in shades of green, and other targeted therapies in shades of orange. Treatment gaps were represented by white space. A Kaplan-Meier curve was generated as a function of time from paclitaxel to death or censoring and was superimposed on the visualization. Separate visualizations assessed progression-free and overall survival (PFS, OS). Hazard ratios (HR) and 95% confidence intervals (CI) from Cox proportional hazard models evaluated the association between prior treatment time and post-paclitaxel OS. Results: Of 877 ER+/HER2- MBC patients diagnosed in 2014, 234 received paclitaxel. Qualitatively, the visualization graphic sorted by OS demonstrated that patients who received treatments for longer durations prior to paclitaxel had worse survival compared to those who received paclitaxel earlier in their treatment course (i.e., shorter time on treatment prior to receiving paclitaxel). Quantitatively, median survival from paclitaxel initiation was 20 months (IQR 8-53). When dividing the sample into quartiles based on overall survival after paclitaxel, median time on treatment prior to paclitaxel was 2 months (IQR 0.3-7), 8 months (1-31 IQR), 10 (1-28) months (IQR), and 11 months (IQR 3-32; Table 2). In adjusted models, every year increase on treatment prior to paclitaxel initiation was associated with a 16% increased yearly hazard of death (HR 1.16, 95% CI 1.05-1.29). Conclusion: Visualizing paclitaxel in the context of disease course demonstrates an association between length of time on prior therapy and remaining OS, highlighting the potential for an overall OS benefit to be observed merely based on early vs. late receipt of treatment. This approach to graphically visualizing treatment sequences can aid in better understanding treatment patterns and their impact on survival outcomes through the power of patient-level data. This study should promote future evaluation of treatment sequencing and duration of prior therapies when studying the impact of new treatments, which will be perpetually important as new FDA-approved medications are incorporated into existing MBC treatment paradigms. Citation Format: Gabrielle Rocque, Aidan Gilbert, Courtney P Williams, Arie Nakhmani, Pravinkumar G Kandhare, Andres Azuero, Smita Bhatia, Kelly M Kenzik, Mark E Burkard. Visualization of the relationship between survival and sequential treatments in metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-15-05.

Modeling passive data collected by smartphones, or digital phenotyping, may help detect the early signs of declines in daily health and lead to steps to prevent declines. Health-related outcomes have been typically acquired through self-report measures, however this broad approach has several limitations, such as recall and social desirability bias. A potential solution is digital phenotyping. Guided by the Arksey and O’Malley methodological framework, the aim of this scoping review was to identify studies that modeled passive smartphone-sensor data into behavioral markers that correlate or predict health-related outcomes. A literature search of peer-reviewed or conference studies in PubMed, Scopus, Compendex, and HTA yielded 3,170 articles. 40 studies met the inclusion criteria. Studies were organized and assessed for their: 1) data collection approaches (e.g., smartphone passive sensor data and questionnaire), 2) feature extraction (e.g., converting bedtime or wake time into sleep), 3) data analytics (e.g., identifying accelerometer data into sleep patterns using machine learning), 4) behavioral markers, which is observing the activity pattern for an extended period of time and then modeling the activities into appropriate behaviors, and 5) health-related outcomes. The findings of this study demonstrate how to transform passive smartphone-sensor data into behavioral markers that correlate or predict health-related outcomes, which could provide information for more grounded predictive use and successful implementation of digital phenotyping in future research.

OBJECTIVES: To examine whether self-reported added sugar consumption is associated with an increased risk for prediabetes in U.S. adults. METHODS: A secondary data analysis was performed using National Health and Nutrition Examination Survey data collected between 2013–2018 in a subsample of adults (≥20 years) with prediabetes (HgbA1c 5.7% to 6.4%) and normoglycemia (HgbA1c 15% g/day) were associated with an increased odds of prediabetes. RESULTS: In the sample of 10,671 adults, 34% were identified as having prediabetes, consuming an estimated average of 49.4 g/day of added sugar. In unadjusted models, added sugar was not relevantly associated with an increased odds of prediabetes [total: (OR = 1.001, P = 0.625); tertiles (reference: 15% (OR = 1.057, P = 0.531)]. Similarly, in adjusted models that controlled for age, gender, race/ethnicity, total energy intake, physical activity status, smoking status, BMI, and socioeconomic covariates, added sugar was not relevantly associated with an increased odds of prediabetes [total: (OR = 1.001, P = 0.601); tertiles (reference: 15% (OR = 1.053, P = 0.665)]. CONCLUSIONS: Results indicate that self-reported added sugar consumption does not appear to relevantly increase the odds of prediabetes in adults. Because prediabetes is an early indicator of type 2 diabetes risk, it is possible that exposure to added sugar over time contributes to the significant associations observed in individuals with type 2 diabetes and not prediabetes. FUNDING SOURCES: University of Alabama at Birmingham Graduate School and School of Nursing.

Background Little is known about the prevalence of healthy lifestyle (HLS) discussions between providers and older cancer survivors. Methods We utilized cross‐sectional data from older cancer survivors (≥65 years) seen at 12 southeastern cancer centers during 2013‐2015. Data on demographics, time since diagnosis, weight, height, and healthy behaviors were collected. Respondents were asked if providers (oncologists, other physicians, and/or nurses) discussed exercise, healthy diet, weight management, and/or smoking cessation during clinical encounters. Descriptive statistics and bivariate associations between HLS topics and survivor characteristics were calculated. Results Among 1460 cancer survivors, mean age was 74 years (SD 6), most were white (81%), and >1 year postdiagnosis (84%). The majority (71%) reported discussing at least one of three HLS topics (exercise 49%, healthy diet 53%, vegetable consumption 28%); 17% received counseling on all three. Weight loss was recommended to 33% of overweight/obese survivors and smoking cessation to 85% of current smokers. Oncologists and nurses discussed HLS less frequently compared to other physicians. Younger survivors (65‐74 years) received recommendations for exercise, weight loss, and tobacco cessation more often than older survivors (≥75 years). Compared to white respondents, minorities reported discussions on all topics more often except for tobacco cessation. Excluding tobacco cessation, survivors with recent cancer diagnoses (1 year postdiagnosis. Conclusion Despite the American Cancer Society's recommendations, older survivors reported a low prevalence of HLS discussions with their providers, with some variation by demographic groups. Strategies are needed to promote these important discussions in this population., Provider's recommendations for weight management, healthy diet, physical activity, and smoking cessation are key in promoting healthy lifestyles (HLS) among older cancer survivors. However, we found that not all survivors discuss all relevant HLS with their providers, with some groups of survivors having these discussions less often than others. Additional studies and strategies are needed to promote HLS discussions and achieve the American Cancer Society's (ACS) recommended HLS goals especially for diet, weight, and physical activity among older cancer survivors in the Southeastern US healthcare system

Although CDC guidelines call for universal, "opt-out" HIV testing, barriers to testing continue to exist throughout the United States, with the rural South particularly vulnerable to both HIV infection and decreased awareness of status. Therefore, the objectives of this study were to evaluate uptake of "opt-out" HIV testing and barriers to testing within the primary care setting in the South. A concurrent triangulation design guided the collection of quantitative data from patients (N = 250) and qualitative data from providers (N = 10) across three primary health clinics in Alabama. We found that 30% of patients had never been tested for HIV, with the highest ranked barrier among patients being perceived costs, access to specialty care, and not feeling at risk. Significant differences existed in perceived barriers between patients and providers. Increased provider-patient engagement and the routine implementation of "opt-out" HIV testing would effectively reveal and mitigate barriers to testing, thus, increasing awareness of status.

Background: Improving family caregiver preparation for surrogate decision making is a critical priority. Objective: Determine a parsimonious set of intrapersonal factors associated with family caregivers' confidence in making future medical decisions for their relatives with cancer. Methods: Cross-sectional mail survey. Family caregivers of Medicare beneficiaries with pancreatic, lung, brain, ovarian, head and neck, hematologic, and stage IV cancers from communities of eight U.S. cancer centers. Participants completed validated measures of their social and mental health, self-care behaviors, coping styles, and surrogate decision-making confidence. Using linear modeling, the Bayesian information criterion was used to identify factors associated with decision-making confidence. A bootstrap approach was used to conduct penalized inference on the selected model coefficients. Model fit validation was assessed with a random forest ensemble. Results: Caregivers (n = 294) were on average 65.5 years old, mostly female (72.8%), and care recipients' spouse/partner (60.2%). The parsimonious set of factors associated with low caregiver decision-making confidence included less engagement in spiritual growth self-care, more use of avoidant coping, low emotional social support, and younger care recipient age (in-sample R(2) = 0.22). These factors were also identified by a random forest approach. After overfitting adjustment (shrunken R(2) = 0.09), the strongest associations with low surrogate decision-making confidence were low spiritual growth self-care (adjusted standardized B = 0.17, p = 0.005) and high use of avoidant coping (adjusted standardized B = −0.12, p = 0.049). Discussion: Identifying strategies to enhance spiritual growth and reduce avoidant coping may be promising targets for interventions to improve family caregivers' confidence in future surrogate decision making.

CONTEXT: Research priority guidelines highlight the need for examining the “dose” components of palliative care (PC) interventions, such as intervention adherence and completion rates, that contribute to optimal outcomes. OBJECTIVES: Examine the “dose” effect of PC intervention completion vs. non-completion on quality of life (QoL) and healthcare use in patients with advanced heart failure (HF) over 32 weeks. METHODS: Secondary analysis of the ENABLE CHF-PC intervention trial for patients with New York Heart Association (NYHA) Class III/IV HF. ‘Completers’ defined as completing a single, in-person outpatient palliative care consultation (OPCC) plus six weekly, PC nurse coach-led telehealth sessions. ‘Non-completers’ were defined as either not attending the OPCC or completing < 6 telehealth sessions. Outcome variables were QoL and healthcare resource use (hospital days; emergency department visits). Mixed models were used to model dose effects for ‘completers’ vs ‘non-completers’ over 32 weeks. RESULTS: Of 208 intervention group participants, 81 (38.9%) were classified as ‘completers’ with a mean age of 64.6 years; 72.8% were urban-dwelling; 92.5% had NYHA Class III HF. ‘Completers’ vs. ‘non-completers’ groups were well-balanced at baseline; however ‘non-completers’ did report higher anxiety (6.0 vs 7.0, p

Importance National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations. Objective To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure. Design, Setting, and Participants A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals. Interventions The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks. Main Outcomes and Measures Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered “fairly good” quality of life; and the Functional Assessment of Chronic Illness Therapy–Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits). Results Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7;d = 0.07 [95% CI, −0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8;d = 0.12 [95% CI, −0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety,d = −0.02 [95% CI, –0.20 to 0.16]; HADS-depression,d = –0.09 [95% CI, –0.24 to 0.06]). Conclusions and Relevance This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement. Trial Registration ClinicalTrials.gov Identifier:NCT02505425

Women living with HIV are disproportionally affected by depression and mental healthcare access. A pilot feasibility trial using videoconferencing compared cognitive behavioral therapy for antiretroviral therapy adherence and depression ( N = 11) to supportive psychotherapy ( N = 11). Participants completed 10–12 weekly therapy sessions and 6-month follow-up. Retention at 6 months was 95 percent. Depression symptoms significantly decreased in both arms; antiretroviral therapy adherence remained high as measured via self-report and Wisepill. Satisfaction with intervention components was high; videoconferencing was highly acceptable and comparable to face-to-face counseling. This study demonstrates the feasibility of telemedicine-administered psychotherapy addressing mental health needs among women living with HIV.

PURPOSE: To compare two implementation telephone-based strategies of an evidence-based educational and support intervention to Rural Breast Cancer Survivor (RBCS) in which education was delivered early or after the support component. METHODS: Florida RBCS participated in a 12-month randomized clinical trial (RCT) with two arms: Early Education and Support (EE-S), and Support and Delayed Education (S-DE). Arms differed in the timing of 6 support and 3 education sessions. Main outcome was quality of life (QOL, SF-36 physical and mental composite scores [PCS, MCS]). Secondary outcomes were depressive symptoms (Centers for Epidemiologic Studies Depression Scale, CES-D), mood (Profile of Mood States, POMS), and social support (Medical Outcomes Study - Social Support Survey, MOS-SSS). Outcomes were analyzed longitudinally using repeated measures models fitted with linear mixed methods. RESULTS: Of 432 RBCS (mean 25.6 months from diagnosis), about 48% were 65+, 73% married/partnered, 28% with ≤high school education. There were no differences between EE-S and S-DE in demographics or outcomes at baseline (Mean (Standard deviation): SF-36 PCS: 44.88 (10.6) vs. 45.08 (10.6) ; MCS: 49.45 (11.1) vs. 48.1 (11.9); CES-D: 10.11 (9.8) vs. 10.86 (10.5) ; POMS-SF: 23.95 (38.6) vs. 26.35 (38.8); MOS-SSS: 79.2 (21.2) vs. 78.66 (21.2)) or over time. One exception was slightly worse mean scores at month 9 in MCS (Cohen’s d −0.22, 95% CI: −0.38, −0.06) and POMS (Cohen’s d 0.23, 95% CI: 0.07, 0.39) for EE-S vs. S-DE. CONCLUSIONS: The implementation strategies were equivalent. IMPLICATIONS FOR SURVIVORS: Enhancing support may be considered before delivering not-in-person interventions to RBCS.

BACKGROUND The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

To determine the effects of gamification on student education, researchers implemented "Kaizen," a software-based knowledge competition, among a first-year class of undergraduate nursing students. Multiple-choice questions were released weekly or biweekly during two rounds of play. Participation was voluntary, and students could play the game using any Web-enabled device. Analyses of data generated from the game included (1) descriptive, (2) logistic regression modeling of factors associated with user attrition, (3) generalized linear mixed model for retention of knowledge, and (4) analysis of variance of final examination performance by play styles. Researchers found a statistically significant increase in the odds of a correct response (odds ratio, 1.8; 95% confidence interval, 1.0-3.4) for a round 1 question repeated in round 2, suggesting retention of knowledge. They also found statistically significant differences in final examination performance among different play styles.To maximize the benefits of gamification, researchers must use the resulting data both to power educational analytics and to inform nurse educators how to enhance student engagement, knowledge retention, and academic performance.

Background National Comprehensive Cancer Network (NCCN) guideline-based treatment is a marker of high-quality care. The impact of guideline discordance on cost and health care utilization is unclear. Materials and Methods This retrospective cohort study of Medicare claims data from 2012 to 2015 included women age ≥65 with stage I–III breast cancer receiving care within the University of Alabama at Birmingham Cancer Community Network. Concordance with NCCN guidelines was assessed for treatment regimens. Costs to Medicare and health care utilization were identified from start of cancer treatment until death or available follow-up. Adjusted monthly cost and utilization rates were estimated using linear mixed effect and generalized linear models. Results Of 1,177 patients, 16% received guideline-discordant treatment, which was associated with nonwhite race, estrogen receptor/progesterone receptor negative, human epidermal growth receptor 2 (HER2) positive, and later-stage cancer. Discordant therapy was primarily related to reduced-intensity treatments (single-agent chemotherapy, HER2-targeted therapy without chemotherapy, bevacizumab without chemotherapy, platinum combinations without anthracyclines). In adjusted models, average monthly costs for guideline-discordant patients were $936 higher compared with concordant (95% confidence limits $611, $1,260). For guideline-discordant patients, adjusted rates of emergency department visits and hospitalizations per thousand observations were 25% higher (49.9 vs. 39.9) and 19% higher (24.0 vs. 20.1) per month than concordant patients, respectively. Conclusion One in six patients with early-stage breast cancer received guideline-discordant care, predominantly related to undertreatment, which was associated with higher costs and rates of health care utilization. Additional randomized trials are needed to test lower-toxicity regimens and guide clinicians in treatment for older breast cancer patients. Implications for Practice Previous studies lack details about types of deviations from chemotherapy guidelines that occur in older early-stage breast cancer patients. Understanding the patterns of guideline discordance and its impact on patient outcomes will be particularly important for these patients. This study found 16% received guideline-discordant care, predominantly related to reduced intensity treatment and associated with higher costs and rates of health care utilization. Increasing older adult participation in clinical trials should be a priority in order to fill the knowledge gap about how to treat older, less fit patients with breast cancer.

Background Palliative care is specialized medical care for people with serious illness that is focused on providing relief from symptoms and stress and improving the quality of life (QOL) for patients and their families. To help the 6.5 million U.S. adults and families affected by heart failure manage the high symptom burden, complex decision-making, and risk of exacerbation and death, the early integration of palliative care is critical and has been recommended by numerous professional organizations. However, few trials have tested early outpatient community-based models of palliative care for patients diagnosed with advanced heart failure and their caregivers. To address this gap, through a series of formative evaluation trials, we translated an oncology early palliative care telehealth intervention for heart failure to create ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends, Comprehensive Heartcare for Patients and Caregivers). Methods/Design The primary objective of this multisite pragmatic randomized controlled trial is to test the efficacy of ENABLE CHF-PC plus usual heart failure care compared to usual care alone. Community-dwelling persons who are ≥50 years of age with New York Heart Association class III/IV or American Heart Association/American College of Cardiology stage C/D heart failure and their primary caregiver (if present) are being randomized to one of two study arms. The ENABLE CHF-PC intervention group receives usual heart failure care plus an in-person palliative care assessment by a board-certified palliative care provider (caregivers are invited to attend), a series of nurse coach-led, weekly psychoeducational 20 to 60 min phone sessions using a guidebook called Charting Your Course (patients: 6 sessions and caregivers: 4 sessions), and monthly check-in calls. Charting Your Course topical content includes problem-solving, coping, self-care and symptom management, communication, decision-making, advance care planning, and life review (patients only). Primary outcomes include patient QOL and mood (depressive symptoms/anxiety) and caregiver QOL, mood, and burden at 8 and 16 weeks after baseline. Outcomes will be examined using an intention-to-treat approach and mixed effects modeling for repeated measures. Discussion This trial will determine whether the ENABLE CHF-PC model of concurrent heart failure palliative care is superior to usual heart failure care alone in achieving higher patient and caregiver QOL, improving mood, and lowering burden. Trial registration ClinicalTrials.gov, NCT02505425. Registered on 22 July 2015. Electronic supplementary material The online version of this article (10.1186/s13063-018-2770-9) contains supplementary material, which is available to authorized users.

Objectives The purpose of this study was to test the efficacy of MOUTh (Managing Oral Hygiene Using Threat Reduction), a nonpharmacologic, relationship-based intervention vs. control on 2 primary outcomes for nursing home (NH) residents with dementia who resisted mouth care: (i) reduction in the occurrence and intensity of care-resistant behaviours (CRBs) and (ii) improvement in oral health. Two secondary outcomes were also examined: (i) the duration of mouth care and (ii) the completion of oral hygiene activities. Background Persons with dementia who exhibit CRBs are at risk for inadequate mouth care and subsequent systemic illnesses. Materials and methods The study used a randomised repeated measures design. Recruitment occurred in 9 nursing homes that varied in size, ownership, reimbursement patterns and location. One hundred and one nursing home residents with dementia were randomised at the individual level to experimental (n = 55) or control groups (n = 46). One hundred participants provided data for the analyses. Results Compared to the control group, persons in the experimental group had twice the odds of allowing mouth care and completing oral hygiene activities; they also allowed longer duration of mouth care (d = 0.56), but showed only small reductions in the intensity of CRBs (d = 0.16) and small differential improvements in oral health (d = 0.18). Conclusion The data suggest that this intervention facilitates mouth care among persons with dementia. The management of refusal behaviour may be a clinically more realistic approach than reducing or eradicating refusals.