Effects of aerobic exercise on neurocognitive function in postmenopausal women receiving endocrine therapy for breast cancer: The Exercise Program in Cancer and Cognition randomized controlled trial.

Objective: The Exercise Program in Cancer and Cognition (EPICC) Study was a randomized controlled trial (RCT) designed to determine whether six months of moderate-intensity aerobic exercise improves neurocognitive function in women with breast cancer (BC) receiving endocrine therapy (ET). Methods: Postmenopausal women with hormone receptor+, early-stage BC, within two years post-primary therapy were randomized to the exercise intervention (six months, ≥150 minutes of moderate-intensity aerobic exercise/week) or usual care control condition. Outcomes were assessed at pre-randomization and after intervention completion. Groups were compared using linear mixed-effects modeling. Results: Participants (N=153) were X ¯ = 62.09 ± 8.27 years old, with stage I BC (64.1%) and a median of 4.7 months post-diagnosis. We found a group-by-time interaction (p=0.041) and a trend for the main effect of time (p=0.11) for processing speed with improved performance in the exercise group and no change in the controls. Similar main effects of time were observed for learning and memory (p=0.024) and working memory (p=0.01). Better intervention adherence was associated with improved processing speed (p=0.017). Conclusions: Six months of moderate-intensity aerobic exercise improves processing speed in postmenopausal women with BC receiving ET who initiate exercise within two years of completing primary therapy (surgery +/- chemotherapy). This is the first large-scale study to examine the effects of aerobic exercise on neurocognitive function in women with BC. Additional research is needed to address the long-term effects of aerobic exercise on cognitive function.

Health-related quality of life over chemotherapy course among individuals with early-stage breast cancer: the association of social determinants of health and neighborhood socioeconomic disadvantage.

PURPOSE: This study aimed to examine relationships between health-related quality of life (HRQOL), social determinants of health, and neighborhood socioeconomic disadvantage in individuals with early-stage breast cancer (ESBC) during chemotherapy. METHODS: This is a longitudinal study that recruited Black and White women with ESBC receiving chemotherapy. Participants completed questionnaires recording their sociodemographic information at baseline and the Functional Assessment of Cancer Therapy-General (FACT-G) to report their HRQOL before each chemotherapy cycle. Linear mixed modeling was employed to examine the associations between FACT-G scores, self-reported race, and area deprivation index (ADI) before and at the last chemotherapy cycle, with the duration of chemotherapy treatment as a covariate. RESULTS: A total of 84 Black and 146 White women with ESBC completed the surveys. Linear mixed modeling results suggested that women with ESBC who reported being Black experienced significantly worse physical well-being than those who reported being White throughout chemotherapy, with a 0.22-point lower average (p = 0.02). Both Black and White women with ESBC experienced decreased functional well-being over the chemotherapy, and Black women consistently reported lower scores than White women, with the change in functional well-being over time differing between racial groups (p = 0.03). Participants' ADI national percentiles were not significantly associated with their HRQOL throughout chemotherapy. CONCLUSIONS: These findings underscore possible racial differences in some dimensions of HRQOL during chemotherapy among women with ESBC. Future research should consider further assessing life stressors and past experiences of discrimination and racism that may contribute to these disparities and guide proactive interventions.

Dynamic Associations Between Daily Pain and Mood during Chemotherapy for Gynecologic Cancers.

BACKGROUND: Pain and mood disturbances, such as anxiety and depression, are common symptoms in gynecologic cancer. Their associations and the role of personality traits in pain adaptation during chemotherapy remain unclear. This ancillary data analysis aimed to investigate these relationships. AIM: To (1) depict the temporal trend of daily pain severity; (2) evaluate dynamic associations between mood and pain; and (3) explore personality traits (neuroticism and conscientiousness) as moderators of the mood-pain relationship during chemotherapy for gynecologic cancer. METHOD: Symptom severity was assessed daily throughout chemotherapy, while personality, clinical, and demographic characteristics were assessed at baseline. Twenty-seven women with gynecologic cancer who completed daily symptom assessments for at least four cycles were included in the analyses. RESULTS: Pain severity decreased slightly during chemotherapy. Multilevel modeling supported significant associations between pain and anxiety (b = 0.24, standard error [SE] = 0.06, p = .001) and depression (b = 0.30, SE = 0.08, p = .002). Time-varying effect modeling showed significant associations between anxiety and pain that initially increased and then decreased; and significant associations between depression and pain steadily decreased over the first four cycles of chemotherapy. Neuroticism moderated the association between anxiety and pain (b = 0.15, SE = 0.06, p < .05), with anxiety more strongly associated with pain in those with higher neuroticism. CONCLUSIONS: This study highlights the dynamic nature of pain and its associations with anxiety and depression in individuals with gynecologic cancer undergoing chemotherapy. The findings have implications for understanding pain and developing tailored psychosocial symptom management interventions to prevent pain during chemotherapy.

Perceived and calculated diet quality improvements in a randomized mHealth weight loss trial.

The diet quality of US adults is poor and cross-sectional analyses suggest self-perception of healthful dietary intake may be overestimated. This analysis assessed the concordance between calculated and perceived diet quality and changes in diet quality among adults seeking weight loss and enrolled in a 12-month randomized behavioral trial. Healthy Eating Index-2015 diet quality (HEI) was calculated from self-administered 24-hour recalls. Perceived diet quality (PDQ) was measured on a 100-point scale. Higher scores indicate better diet quality. Concordance was assessed using the concordance correlation coefficient and Bland-Altman plots. The one hundred and five participants with complete dietary data were mostly female and white. There was good agreement between HEI and PDQ scores at 12 months for less than a third of participants. Most of the disagreement arose from PDQ scores being higher than HEI scores. Even fewer participants had good agreement between HEI changes and PDQ changes. Participants perceived greater improvement in diet quality than indicated by HEI score changes. Concordance was low at 12 months and for change in diet quality. Despite the diet quality of adults seeking weight loss being suboptimal and not improving, many perceived their diet quality and diet quality improvements as better than calculated. Future studies might explore the effect of misperceptions on weight loss outcomes.

The feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game for women with advanced breast or gynecologic cancer.

BACKGROUND: Cancer clinicians and systems aim to provide patient-centered care, but not all patients have the self-advocacy skills necessary to ensure their care reflects their needs and priorities. This study examines the feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game (an educational video game) intervention in women with advanced breast or gynecologic cancer. METHODS: Women with recently diagnosed (<3 months) metastatic breast or advanced gynecologic cancer were randomized 2:1 to receive a tablet-based serious game (Strong Together) (n = 52) or enhanced care as usual (n = 26). Feasibility was based on recruitment, retention, data completion, and intervention engagement. Acceptability was assessed via a postintervention questionnaire and exit interview. Preliminary efficacy was assessed on the basis of change scores from baseline to 3 and 6 months in self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale) using intention-to-treat analysis. RESULTS: Seventy-eight women (55.1% with breast cancer; 44.9% with gynecologic cancer) were enrolled. Feasibility was demonstrated by satisfactory recruitment (69% approach-to-consent rate; 93% enroll-to-randomize rate), retention (90% and 86% at 3 and 6 months, respectively; 85% data completion), and intervention engagement (84% completed ≥75% of the game). Participants endorsed the intervention's (75%) and trial's (87%) acceptability. Participants in the intervention group experienced significant improvements in self-advocacy at 3 and 6 months compared to participants in the control group. CONCLUSIONS: Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising evidence of clinical efficacy. A future confirmatory trial is warranted to test the efficacy of the intervention for patient and health system outcomes.

Effect of an mHealth weight loss intervention on Healthy Eating Index diet quality: the SMARTER randomised controlled trial.

In the few weight loss studies assessing diet quality, improvements have been minimal and recommended calculation methods have not been used. This secondary analysis of a parallel group randomised trial (regsitered: https://clinicaltrials.gov/ct2/show/NCT03367936) assessed whether self-monitoring with feedback (SM + FB) v. self-monitoring alone (SM) improved diet quality. Adults with overweight/obesity (randomised: SM n 251, SM + FB n 251; analysed SM n 170, SM + FB n 186) self-monitored diet, physical activity and weight. Real-time, personalised feedback, delivered via a study-specific app up to three times daily, was based on reported energy, fat and added sugar intake. Healthy Eating Index 2015 (HEI-2015) scores were calculated from 24-hour recalls. Higher scores represent better diet quality. Data were collected August 2018 to March 2021 and analysed spring 2022. The sample was mostly female (78·9 %) and white (85·4 %). At baseline, HEI-2015 total scores and bootstrapped 95 % CI were similar by treatment group (SM + FB: 63·11 (60·41, 65·24); SM: 61·02 (58·72, 62·81)) with similar minimal improvement observed at 6 months (SM + FB: 65·42 (63·30, 67·20); SM: 63·19 (61·22, 64·97)) and 12 months (SM + FB: 63·94 (61·40, 66·29); SM: 63·56 (60·81, 65·42)). Among those who lost ≥ 5 % of baseline weight, HEI-2015 scores improved (baseline: 62·00 (58·94, 64·12); 6 months: 68·02 (65·41, 71·23); 12 months: 65·93 (63·40, 68·61)). There was no effect of the intervention on diet quality change. Clinically meaningful weight loss was related to diet quality improvement. Feedback may need to incorporate more targeted nutritional content.

Incorporation of Serial 12-Lead Electrocardiogram With Machine Learning to Augment the Out-of-Hospital Diagnosis of Non-ST Elevation Acute Coronary Syndrome.

STUDY OBJECTIVE: Ischemic electrocardiogram (ECG) changes are subtle and transient in patients with suspected non-ST-segment elevation (NSTE)-acute coronary syndrome. However, the out-of-hospital ECG is not routinely used during subsequent evaluation at the emergency department. Therefore, we sought to compare the diagnostic performance of out-of-hospital and ED ECG and evaluate the incremental gain of artificial intelligence-augmented ECG analysis. METHODS: This prospective observational cohort study recruited patients with out-of-hospital chest pain. We retrieved out-of-hospital-ECG obtained by paramedics in the field and the first ED ECG obtained by nurses during inhospital evaluation. Two independent and blinded reviewers interpreted ECG dyads in mixed order per practice recommendations. Using 179 morphological ECG features, we trained, cross-validated, and tested a random forest classifier to augment non ST-elevation acute coronary syndrome (NSTE-ACS) diagnosis. RESULTS: Our sample included 2,122 patients (age 59 [16]; 53% women; 44% Black, 13.5% confirmed acute coronary syndrome). The rate of diagnostic ST elevation and ST depression were 5.9% and 16.2% on out-of-hospital-ECG and 6.1% and 12.4% on ED ECG, with ∼40% of changes seen on out-of-hospital-ECG persisting and ∼60% resolving. Using expert interpretation of out-of-hospital-ECG alone gave poor baseline performance with area under the receiver operating characteristic (AUC), sensitivity, and negative predictive values of 0.69, 0.50, and 0.92. Using expert interpretation of serial ECG changes enhanced this performance (AUC 0.80, sensitivity 0.61, and specificity 0.93). Interestingly, augmenting the out-of-hospital-ECG alone with artificial intelligence algorithms boosted its performance (AUC 0.83, sensitivity 0.75, and specificity 0.95), yielding a net reclassification improvement of 29.5% against expert ECG interpretation. CONCLUSION: In this study, 60% of diagnostic ST changes resolved prior to hospital arrival, making the ED ECG suboptimal for the inhospital evaluation of NSTE-ACS. Using serial ECG changes or incorporating artificial intelligence-augmented analyses would allow correctly reclassifying one in 4 patients with suspected NSTE-ACS.

Psychoneurological symptom cluster trajectories in individuals treated for early-stage breast cancer.

BACKGROUND/PURPOSE: The psychoneurological (PN) symptom cluster has been defined in the literature as anxiety, depression, fatigue, sleep disturbance, and pain. PN symptoms are influenced by cancer and its treatment as well as biological and psychosocial factors. The purpose of this analysis was to describe temporal patterns of the PN symptom cluster severity in breast cancer survivors over the year following initial surgical intervention and investigate the time-dependent effect of treatment modality on symptom severity. METHODS: In a prospective longitudinal study, symptom data were collected from individuals with early-stage breast cancer 48 h after initial surgery and at monthly intervals for the subsequent 12 months using the PROMIS®-29 subscales for anxiety, depression, fatigue, sleep disturbance, and pain. Applying group-based trajectory modeling, we classified participants into subgroups with similar temporal patterns of PN symptom cluster severity and included treatment modality as a time-dependent covariate. RESULTS: Across 353 participants (mean age 60.10 ± 11.9 years, 88.95% white, 66.57% undergoing segmental mastectomies), four distinct trajectory subgroups (mild [47.6%; n = 168], moderate [28.3%; n = 100], severe [15.9%; n = 56], and most severe increasing [8.2%; n = 29]) were revealed for PN symptom cluster severity. Chemotherapy was associated with greater severity in all symptom severity subgroups, while radiation was associated with greater symptom severity in the mild and most severe increasing subgroups. CONCLUSIONS AND IMPLICATIONS: A subgroup of individuals with early-stage breast cancer experienced persistent severe PN symptoms. Future research should focus on psychosocial, biological, and disease-related characteristics of individuals in the most severe symptom group to inform preventative treatments and effective interventions.

Is insomnia severity a moderator of the associations between obstructive sleep apnea severity with mood and diabetes-related distress?

PURPOSE: This study examined insomnia severity as a moderator of the associations between obstructive sleep apnea (OSA) severity with impaired mood and diabetes-related distress in adults with OSA and type 2 diabetes (T2D). METHODS: This secondary analysis used pooled baseline data from two randomized controlled trials that evaluated the efficacy of treatment of OSA or insomnia in adults with T2D. Participants for this analysis had OSA (Apnea Hypopnea Index [AHI] ≥ five events/hour obtained from an in-home sleep apnea testing device) and completed questionnaires on insomnia, mood, and diabetes-related distress. Hierarchical multiple linear regression and multivariate linear regression analyses were used controlling for demographic characteristics and restless leg syndrome. RESULTS: Of 240 participants, mean age was 57.8 ± 10.17, 50% were female, and 35% were non-White. Participants had poorly controlled diabetes (Mean HbA1C = 7.93 ± 1.62), and moderate OSA (Mean AHI = 19.3 ± 16.2). Insomnia severity significantly moderated the association between OSA severity and mood (b = -0.048, p = .017). Although insomnia severity did not moderate the relationship between OSA severity and diabetes-related distress (b = -0.009, p = .458), insomnia severity was independently associated with greater diabetes-related distress (b = 1.133, p < .001). CONCLUSIONS: In adults with T2D and OSA, as insomnia severity increased, increasing OSA severity was associated with lower level of mood disturbances. Insomnia independently increased the level of diabetes-related distress. These findings suggest that comorbid insomnia may be more impactful than OSA on increasing mood disturbances and diabetes-related distress in adults with T2D.

Neighborhood Walkability Is Associated with Physical Activity and Prediabetes in a Behavioral Weight Loss Study: a Secondary Analysis.

BACKGROUND: Socio-environmental factors may affect uptake and utility of behavioral interventions targeting weight loss and cardiometabolic health. To evaluate the relation of neighborhood walkability to physical activity (PA) and glucose control in a sample of adults with overweight/obesity participating in a weight loss study. METHODS: Secondary analysis of a 12-month behavioral weight loss intervention (2011-2015) using one-group pretest-posttest design. Neighborhood walkability was assessed via residential Walk Score (0-100) at study entry. Fasting plasma glucose (FPG) via phlebotomy and PA via waist-worn ActiGraph GT3X were assessed at baseline and end of study. Study variables included neighborhood walkability (car-dependent: Walk Score < 50 vs. walkable: Walk Score ≥ 50), prediabetes (FPG 100-125 mg/dL), and recommended PA (moderate to vigorous PA [MVPA] > 22 min/day). Generalized linear model with logit link results were reported as adjusted odds ratios (AOR) with 95% confidence intervals (CI). RESULTS: The sample (N = 114) was mostly female (88.6%), white (83.3%), college educated (73.7%), and on average 51.4 ± 1.0 years of age. At baseline, persons residing in car-dependent neighborhoods tended to have higher income than those in walkable neighborhoods. Neighborhood walkability interacted with household income at study entry to predict participants' ability to meet the MVPA goal at 12 months (AOR = 13.52, 95% CI: 1.86-119.20). Those from walkable neighborhoods had 67% lower odds of having prediabetes compared to those from car-dependent neighborhoods (AOR = 0.33, 95% CI: 0.10-0.87) at 12 months. CONCLUSION: Our findings corroborate previous research characterizing the relationship between neighborhood walkability, PA, and prediabetes status. Key drivers of this impact warrant further investigation in a study with a larger, more diverse sample.

Factors Associated with Nurses' Motivation to Provide Care for Patients with Alcohol Use and Alcohol Use-Related Problems.

BACKGROUND: There is a high human and economic cost associated with alcohol use and alcohol use-related problems. Nurses have a pivotal role in addressing the needs of this patient population. Purpose: The study aimed to examine the correlation between nurses' demographics/background characteristics, personal attitudes, professional attitudes, and their motivation to provide care to patients with alcohol use and alcohol use-related problems. METHODS: A descriptive, cross-sectional correlational design was utilized. Nurses were recruited from four Southwestern Pennsylvania hospitals. The study variables were examined using questionnaires that explored nurses' demographic/background characteristics, their personal and professional attitudes, and motivation to care for patients with alcohol use and alcohol use-related problems. RESULTS: The sample included 234 nurses. Demographic/background characteristics were identified as associated with nurse's alcohol use-related motivation, including gender, primary work setting and specialization. Previous personal experience with alcohol use-related problems (nurses themselves or co-workers), familiarity, perceived dangerousness, fear, social distance, personal responsibility beliefs and disease model were also associated with nurses' alcohol use-related motivation to care for these patients. In addition, all professional attitudes were associated with nurses' motivation toward caring for patients with alcohol use and alcohol use-related problems. CONCLUSIONS: The study revealed that certain demographic/background characteristics and personal and professional attitudes were associated with nurses' motivation to provide care to this patient population. This study provides the foundation for future studies aimed at exploring predictors of nurse's motivation to care for patients with alcohol use and alcohol use-related problems.

The Association between Neighborhood Walkability and Physical Activity in a Behavioral Weight Loss Trial Testing the Addition of Remotely Delivered Feedback Messages to Self-Monitoring.

Adding feedback messages (FB) to self-monitoring (SM) may reinforce behavior change. However, socio-environmental conditions (e.g., limited access to parks or low walkability) may limit one's ability to respond to FB focused on physical activity (PA). In this analysis, we hypothesized that high neighborhood walkability will positively modify the treatment effect of FB on PA, and residents of high walkability neighborhoods will achieve higher PA levels at 12 months than those in low walkability neighborhoods. The study is a secondary analysis of a 12-month behavioral weight-loss trial. Adults with overweight/obesity were randomized to SM + FB (n = 251) or SM alone (n = 251). SM + FB group received smartphone pop-up messages thrice/week tailored to their PA SM data. The assessment included neighborhood walkability via Walk Score (low [<50] vs. high [≥50]), moderate to vigorous PA (MVPA) and step count via Fitbit Charge 2™, and weight via smart scale. We report adjusted linear regression coefficients (b) with standard errors (SE). The analysis included participants who were primarily white, female, and with obesity. In adjusted models, neighborhood walkability did not moderate the effect of treatment assignment on log-transformed (ln) MVPA or steps count over 12 months. The SM + FB group had greater lnMVPA than the SM group, but lnMVPA and steps were similar between walkability groups. There were no significant interactions for group and time or group, time, and walkability. These findings suggest that adding FB to SM had a small but significant positive impact on PA over 12 months, but neighborhood walkability did not moderate the treatment effect of FB on PA.

Postdischarge Nausea and Vomiting and Co-occurring Symptoms in Women Following Breast Cancer Surgery.

PURPOSE: The purpose of this study was to investigate the influence of potential co-occurring symptoms, including fatigue, sleep disturbance, anxiety, depressive symptoms, and pain, on the incidence of postdischarge nausea (PDN) measured two days following discharge to home after surgery for breast cancer. DESIGN: This study used a prospective, cross-sectional, observational design. METHODS: The sample was 334 women aged 27 to 88 years of age. Demographic data were collected from the patient and the medical record before surgery. Symptom data were collected 48 hours following surgery using the Patient Reported Outcome Measurement System (PROMIS) and numerical nausea and pain scales. FINDINGS: Eighty-five (25.4%) of study participants reported some nausea two days after discharge. Study participants who experienced PDN frequently described that it occurred after they left the hospital to drive home following their surgery. Unadjusted odds ratios showed the presence of co-occurring symptoms of anxiety, fatigue, sleep disturbance, and pain were all significantly associated with the presence of nausea 48 hours following surgery. Other significant factors associated with (PDN) were history of motion sickness, history of pregnancy-induced nausea, use of opioids, and type of surgery. CONCLUSIONS: Same-day surgery nurses providing postoperative education for women following surgery for breast cancer should explain to patients that nausea may occur after they are discharged, especially those with known motion sickness. In addition, patients should be informed that other symptoms, especially fatigue, sleep disturbance, and anxiety, may co-occur.

Factors associated with sleep disturbances in women undergoing treatment for early-stage breast cancer.

PURPOSE: The purpose of this study was to examine factors associated with sleep disturbance in women receiving adjuvant therapy for breast cancer. METHODS: This study employed a cross-sectional design using data collected at 3 months post-surgery from an ongoing longitudinal parent study. Participant data were divided into adjuvant treatment groups (chemotherapy, radiation, and aromatase inhibitors) and no adjuvant treatment groups. Symptoms were measured using patient self-report measures. Analysis of variance was used to assess between adjuvant treatment group differences in sleep disturbance. Regression analysis was performed to assess the relationship between sleep disturbance and other symptoms within adjuvant treatment groups. RESULTS: The sample included 156 women diagnosed with early-stage breast cancer. There were significant differences in levels of reported sleep disturbance between treatment groups (p = 0.049), with significantly higher levels of sleep disturbances in those receiving radiation compared to those receiving no adjuvant treatment (p = 0.038) and in those receiving chemotherapy and those receiving no adjuvant treatment (p = 0.027). Increased sleep disturbance was found to be a significant predictor for increased pain severity, nausea severity, anxiety, depressive symptoms, fatigue, decreased physical function, and decreased ability to participate in social roles and activities. Co-occurring symptoms with sleep disturbance differed between adjuvant treatment groups. Sleep disturbance was also associated with younger age (p = 0.008). CONCLUSIONS: Patients undergoing chemotherapy or radiation for breast cancer report higher levels of sleep disturbance than those not receiving adjuvant therapy. Sleep disturbance is associated with other symptoms experienced by patients with cancer and thus requires continual assessment and future research into effective interventions.

Trajectories of neuropsychological symptom burden in postmenopausal women prescribed anastrozole for early-stage breast cancer.

PURPOSE: Aromatase inhibitors (AIs) prolong survival for postmenopausal women with hormone receptor-positive breast cancer (HR + BC) but also burden patients with symptoms, a major reason for suboptimal AI adherence. This study characterizes inter-relationships among symptom measures; describes neuropsychological symptom burden trajectories; and identifies trajectory group membership predictors for postmenopausal women prescribed anastrozole for HR + BC. METHODS: This study utilized prospectively collected data from a cohort study. Relationships among various self-reported symptom measures were examined followed by a factor analysis to reduce data redundancy before trajectory analysis. Four neuropsychological scales/subscales were rescaled (range 0-100) and averaged into a neuropsychological symptom burden (NSB) score, where higher scores indicated greater symptom burden. Group-based trajectory modeling characterized NSB trajectories. Trajectory group membership predictors were identified using multinomial logistic regression. RESULTS: Women (N = 360) averaged 61 years old, were mostly White, and diagnosed with stage I HR + BC. Several measures were correlated temporally but four neuropsychological measures had strong correlations and dimensional loadings. These four measures, combined for the composite NSB, averaged (mean ± standard deviation) 17.4 ± 12.9, 18.0 ± 12.7, 19.5 ± 12.8, and 19.8 ± 13.0 at pre-anastrozole, 6, 12, and 18 months post-initiation, respectively. However, the analysis revealed five NSB trajectories-low-stable, low-increasing, moderate-stable, high-stable, and high-increasing. Younger age and baseline medication categories (pre-anastrozole), including anti-depressants, analgesics, anti-anxiety, and no calcium/vitamin D, predicted the higher NSB trajectories. CONCLUSION: This study found relationships among neuropsychological symptom measures and distinct trajectories of self-reported NSB with pre-anastrozole predictors. Identifying symptom trajectories and their predictors at pre-anastrozole may inform supportive care strategies via symptom management interventions to optimize adherence for women with HR + BC.

Effect of Treatment of OSA With CPAP on Glycemic Control in Adults With Type 2 Diabetes: The Diabetes Sleep Treatment Trial (DSTT).

OBJECTIVE: The effect of obstructive sleep apnea (OSA) treatment with continuous positive airway pressure (CPAP) on glycemic measures in patients with type 2 diabetes (T2D) remains unclear. We aimed to determine whether CPAP treatment of OSA improves glycemic measures in patients with T2D. METHODS: This randomized controlled trial (N = 98) examined changes in glycemic measures following 12 weeks of active (n = 49) or sham (n = 49) CPAP and consideried participants' adherence to CPAP therapy (percentage of days with ≥4 hours use and average hours/day of use). RESULTS: Baseline treatment groups were similar. Regarding the efficacy of active vs sham-CPAP over time, at 6 weeks, both groups had similar reductions in fructosamine (mean difference [MD], 95% confidence interval [CI]: CPAP -13.10 [-25.49 to -0.7] vs. sham -7.26 [-20.2 to 5.69]; P = .519) but different in HbA1c (CPAP -0.24 [-0.48 to -0.003] vs sham 0.15 [-0.10 to 0.4]; P = .027). At 12 weeks, reductions in HbA1c values were similar by group (CPAP -0.26 [-0.53 to 0.002] vs sham -0.24 [-0.53 to 0.04]; P = .924). HbA1c reductions were associated with a greater percentage of cumulative days of CPAP usage ≥4 hours per day (b [SE] = 0.006 [0.002]; P = .013) and cumulative hours of CPAP use (b [SE] = 0.08 [0.08]; P = .012). CPAP use of ≥7 hours was associated with a significant reduction in HbA1c (b [SE] 0.54 [0.16]; P = .0012). CONCLUSION: CPAP treatment of OSA did not result in sustained improved glycemic control compared to sham in the intent-to-treat analysis. CPAP adherence was associated with greater improvements in glycemic control.

Metabolic outcomes in adults with type 2 diabetes and sleep disorders.

PURPOSE: Insomnia is frequently co-morbid with obstructive sleep apnea (OSA); the effect of insomnia or co-morbid insomnia and OSA (OSA + I) on associated metabolic outcomes in adults with type 2 diabetes (T2D) remains unclear. This study in adults with T2D compared metabolic outcomes among persons with OSA, insomnia, or OSA + I. METHODS: This study analyzed baseline data from the Diabetes Sleep Treatment Trial of persons recruited for symptoms of OSA or poor sleep quality. Home sleep studies determined OSA presence and severity. Insomnia was evaluated using the Insomnia Severity Index. Height and weight to calculate body mass index (BMI) and blood for laboratory values were obtained. Multivariate general linear models were used to examine the impact of the type of sleep disorder and sociodemographic, lifestyle, and sleep risk factors on metabolic outcomes. RESULTS: Participants (N = 253) were middle-aged (56.3 ± 10.5 years), white (60.5%), obese (mean BMI of 35.3 ± 7.1 kg/m2), and male (51.4%) with poor glucose control (mean HbA1c of 8.0 ± 1.8%). Most participants had OSA + I (42.7%) or insomnia only (41.0%). HbA1c and BMI differed among the sleep disorder groups. In addition, in the adjusted models, having insomnia only, compared to OSA only, was associated on average with higher HbA1c levels (b = 1.08 ± 0.40, p < 0.007) and lower BMI (b = - 7.03 ± 1.43, p < 0.001). CONCLUSIONS: Findings suggest that insomnia frequently co-exists with OSA, is independently associated with metabolic outcomes in adults with T2D, and should be considered in investigations of the effects of OSA in persons with T2D. TRIAL REGISTRATION: Diabetes-Obstructive Sleep Apnea Treatment Trial (NCT01901055), https: Clinicaltrials.gov/ct2/show/NCT01901055; Registration date: July 17, 2013.

The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial.

BACKGROUND: Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials. OBJECTIVE: The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2. METHODS: All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal). RESULTS: Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001). CONCLUSIONS: There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools. TRIAL REGISTRATION: Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.

The association between sleep health and weight change during a 12-month behavioral weight loss intervention.

BACKGROUND: Prior research on the relationship between sleep and attempted weight loss failed to recognize the multidimensional nature of sleep. We examined the relationship between a composite measure of sleep health and change in weight and body composition among adults in a weight loss intervention. METHODS: Adults (N = 125) with overweight or obesity (50.3 ± 10.6 years, 91% female, 81% white) participated in a 12-month behavioral weight loss intervention, with assessments of sleep, weight, fat mass, and fat-free mass at baseline, 6 months, and 12 months. Six sleep dimensions (regularity, satisfaction, alertness, timing, efficiency, and duration) were categorized as "good" or "poor" using questionnaires and actigraphy. A composite score was calculated by summing the number of "good" dimensions. Obstructive sleep apnea (OSA) was assessed in a subsample (n = 117), using the apnea-hypopnea index (AHI) to determine OSA severity. Linear mixed modeling was used to examine the relationships between sleep health and outcomes of percent weight, fat mass, or fat-free mass change during the subsequent 6-month interval, adjusting for age, sex, bed partner, and race; an additional model adjusted for AHI. RESULTS: Mean baseline and 6-month sleep health was 4.5 ± 1.1 and 4.5 ± 1.2, respectively. Mean weight, fat mass, and fat-free mass changes from 0 to 6 months were -9.3 ± 6.1%, -16.9 ± 13.5%, and -3.4 ± 3.4%, respectively, and 0.4 ± 4.8%, -0.3 ± 10.3%, and 0.7 ± 4.1% from 6 to 12 months. Better sleep health was associated with greater subsequent weight loss (P = 0.016) and fat loss (P = 0.006), but not fat-free mass loss (P = 0.232). Following AHI adjustment, the association between sleep health and weight loss was attenuated (P = 0.102) but remained significant with fat loss (P = 0.040). Regularity, satisfaction, timing, and efficiency were each associated with weight and/or fat loss (P ≤ 0.041). CONCLUSIONS: Better sleep health was associated with greater weight and fat loss, with associations attenuated after accounting for OSA severity. Future studies should explore whether improving sleep health, OSA, or the combination improves weight loss.

Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer.

Physical activity may improve cognitive function in women with breast cancer. In a cross-sectional study, we explored the relationship between cognitive function and physical activity (actigraph) and cardiorespiratory fitness (sub-maximal graded exercise test) in 73 postmenopausal women with early stage breast cancer prior to the initiation of systemic adjuvant therapy. Cognitive function was assessed with a standardized battery of neurocognitive measures assessing eight domains. Data were analyzed using partial correlations, controlling for age and total hours of actigraph wear-time. Women were, on average, 63.71 (± 5.3) years of age with 15.47 (± 2.48) years of education. For physical activity, greater average number of steps per day were associated with better attention (r = .262, p = .032) and psychomotor speed (r = .301, p = .011); greater average hours of moderate and moderate/vigorous intensity physical activity were associated with better visual memory (r = .241, p = .049; r = .241, p = .049, respectively); and greater average daily energy expenditure was associated with better visual memory (r = .270, p = .027) and psychomotor speed (r = .292, p = .017). For fitness, higher peak maximum VO2 was associated with better concentration (r = .330, p = .006), verbal memory (r = .241, p = .048), and working memory (r = .281, p = .019). These results suggest that higher levels of physical activity and cardiorespiratory fitness are associated with better cognitive function in postmenopausal women with breast cancer. Randomized controlled trials (RCT) to examine whether physical activity improves cognitive function in women with breast cancer are warranted. These RCTs should also determine the mechanisms of the influence of physical activity on cognitive function. CLINICAL TRIALS REGISTRATION NUMBER: NCT02793921; Date: May 20, 2016.