Daytime symptom trajectories among adults with stable heart failure and insomnia: evidence from a randomised controlled trial of cognitive behavioural therapy for insomnia.

People with heart failure (HF) experience a high symptom burden and prevalent insomnia. However, little is known about daytime symptom trajectories after cognitive behavioural therapy for insomnia (CBT-I). In this study we describe: (1) daytime symptom trajectories among adults with insomnia and stable HF over 1 year, (2) how symptom trajectories differ between CBT-I versus HF self-management interventions, and (3) associations between demographic, clinical, and sleep characteristics, perceived stress, health-related quality of life (HRQoL), functional performance and daytime symptoms trajectories. We retrospectively analysed data from a randomised controlled trial of CBT-I versus HF self-management (NCT0266038). We measured sleep, perceived stress, HRQoL, and functional performance at baseline and symptoms at baseline, 3, 6, and 12 months. We conducted group-based trajectory modelling, analysis of variance, chi-square, and proportional odds models. Among 175 participants (mean [standard deviation] age 63.0 [12.9] years, 57.1% male, 76% White), we found four daytime symptom trajectories: (A) low improving symptoms (38.3%); (B) low psychological symptoms and high improving physical symptoms (22.8%); (C) high improving symptoms (24.0%); and (D) high not improving symptoms (14.9%). The CBT-I versus the HF self-management group had higher odds of belonging to Group A compared to other trajectories after controlling for baseline fatigue (odds ratio = 3.27, 95% confidence interval 1.39-7.68). The difference between the CBT-I and the HF self-management group was not statistically significant after controlling for baseline characteristics. Group D had the highest body mass index, perceived stress, and insomnia severity and the lowest cognitive ability, HRQoL, and functional performance. Research is needed to further evaluate factors contributing to symptom trajectories.

Correlates of cognition among people with chronic heart failure and insomnia.

PURPOSE: This study aimed to describe cognitive characteristics and their associations with demographic and clinical factors among adults with chronic heart failure (HF) and insomnia. METHODS: We performed a cross-sectional analysis of baseline data from the HeartSleep Study (NCT#02,660,385), a randomized controlled trial designed to evaluate the effects of cognitive-behavioral therapy for insomnia. Demographic characteristics and health history were obtained. We measured sleep characteristics with the Insomnia Severity Index, the PROMIS Sleep Disturbance Questionnaire, and wrist actigraphy. Sleepiness, stress, and quality of life were measured with validated questionnaires. Measures of cognition included frequency of lapses on the psychomotor vigilance test and the PROMIS cognitive abilities scale where ≥ 3 lapses and a score of ≤ 50, respectively, suggested impairment. These variables were combined into a composite score for multivariable analyses. RESULTS: Of a sample that included 187 participants (58% male; mean age 63.1 [SD = 12.7]), 77% had New York Heart Association class I or II HF and 66% had HF with preserved ejection fraction. Common comorbidities were diabetes (35%), hypertension (64%), and sleep apnea (54%). Impaired vigilant attention was associated with non-White race, higher body mass index, less education, and more medical comorbidities. Self-reported cognitive impairment was associated with younger age, higher body mass index, and pulmonary disease. On adjusted analysis, significant risk factors for cognitive impairment included hypertension (OR 1.94), daytime sleepiness (OR 1.09), stress (OR 1.08), and quality of life (OR 0.12). CONCLUSIONS: Impaired cognition is common among people with chronic HF and insomnia and associated with hypertension, daytime sleepiness, stress, and poor quality of life. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: Insomnia Self-management in Heart Failure; NCT#02,660,385.

Symptom Cluster Profiles Among Adults with Insomnia and Heart Failure.

OBJECTIVE/BACKGROUND: Both heart failure (HF) and insomnia are associated with high symptom burden that may be manifested in clustered symptoms. To date, studies of insomnia have focused only on its association with single symptoms. The purposes of this study were to: (1) describe daytime symptom cluster profiles in adults with insomnia and chronic HF; and (2) determine the associations between demographic and clinical characteristics, insomnia and sleep characteristics and membership in symptom cluster profiles. PARTICIPANTS: One hundred and ninety-five participants [M age 63.0 (SD12.8); 84 (43.1%) male; 148 (75.9%) New York Heart Association Class I/II] from the HeartSleep study (NCT0266038), a randomized controlled trial of the sustained effects of cognitive behavioral therapy for insomnia (CBT-I). METHODS: We analyzed baseline data, including daytime symptoms (fatigue, pain, anxiety, depression, dyspnea, sleepiness) and insomnia (Insomnia Severity Index), and sleep characteristics (Pittsburgh Sleep Quality Index, wrist actigraphy). We conducted latent class analysis to identify symptom cluster profiles, bivariate associations, and multinomial regression. RESULTS: We identified three daytime symptom cluster profiles, physical (N = 73 participants; 37.4%), emotional (N = 12; 5.6%), and all-high symptoms (N = 111; 56.4%). Body mass index, beta blockers, and insomnia severity were independently associated with membership in the all-high symptom profile, compared with the other symptom profile groups. CONCLUSIONS: Higher symptom burden is associated with more severe insomnia in people with stable HF. There is a need to understand whether treatment of insomnia improves symptom burden as reflected in transition from symptom cluster profiles reflecting higher to lower symptom burden.

Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE: The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS: Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS: The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS: Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.

Improving Breast Cancer Family Caregivers' Palliative Care Literacy: A Pilot Randomized Trial.

Self- and family management (SFM) refers to patients' and family caregivers' activities to co-manage illness. Two barriers to SFM are low palliative care literacy and lack of goals of care communication, which potentially result in SFM activities that are unsupportive of patients' goals. Managing Cancer Care: A Caregiver's Guide (MCC-CG) aims to improve palliative care literacy and communication within a SFM training program. In this pilot randomized trial, we enrolled breast cancer family caregivers and collected data at 0, 1, and 3 months on palliative care literacy, SFM engagement, communication, transitions management, uncertainty, caregiver burden, and caregiver competence/personal gain. Participants (n = 35) had a mean age of 54 (range: 18-81) and were 66% white and 34% racial/ethnic minorities. Intervention participants improved their palliative care literacy and SFM engagement, reduced uncertainty and caregiver burden, increased competence/personal gain, and had more goals of care conversations over time. MCC-CG has preliminary efficacy, warranting further study.

Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure.

BACKGROUND: Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for people with chronic insomnia, including those with heart failure (HF). Treatment fidelity evaluation is needed to ensure study validity and reliability. OBJECTIVE: The aim of this study was to apply the National Institutes of Health Behavioral Change Consortium framework to ensure adequate treatment fidelity in a randomized controlled trial of CBT-I for people with stable HF. METHODS: We describe strategies to ensure treatment fidelity in study design, provider training, and treatment delivery. We measured treatment receipt (observation and self-report) and enactment of CBT-I strategies (self-report and actigraphy). We used the Dysfunctional Beliefs and Attitudes About Sleep Scale and the Sleep Disturbance Questionnaire to indicate sleep-related beliefs and cognitions. We computed descriptive statistics for demographic characteristics, treatment receipt, and enactment variables. We compared baseline and post-intervention dichotomous sleep behaviors using the two-sided Wilcoxon rank-sum test. We calculated the root mean square of successive difference in time of sleep onset and midpoint (actigraphy) to indicate day-by-day variability in bed and wake times. RESULTS: Most participants completed the CBT-I intervention and follow-up assessments and attended each group or make-up session. Most correctly computed their sleep efficiency and completed their homework. Most participants used the sleep tracker and reported using strategies to improve their sleep schedules. There was a significant decrease in actigraph-measured light intensity during the 30 minutes and 1 hour before bedtime between baseline and post-intervention and no statistically significant changes in light intensity after waking or in nap frequency. Most of those who woke during the night got out of bed, consistent with recommendations. There were significant improvements on all of the Dysfunctional Beliefs and Attitudes About Sleep items and total score and all but one item on the Sleep Disturbance Questionnaire. DISCUSSION: Preserved treatment fidelity may explain the large and sustained effects in people with HF found in our trial. Further research is needed to evaluate CBT-I's effectiveness and implementation strategies among people with HF in real-world clinical settings.

Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia.

BACKGROUND: Almost 50% of people with heart failure (HF) experience chronic insomnia and must perform self-care to manage their day-to-day healthcare needs. Understanding multifactorial influences on self-care, including demographic, clinical, and sleep characteristics, and mood and somatic symptoms will help identify people at highest risk for poor self-care. However, past research focused only on the associations of single symptoms and self-care. Multivariate approaches are needed to account for the synergistic associations of self-care with sleep, mood, and somatic symptoms among people with HF. OBJECTIVES: The aims of the study were to (a) evaluate the levels of self-care maintenance and self-care confidence among people with stable HF and chronic insomnia; (b) identify the clinical and demographic correlates of self-care maintenance and confidence among people with stable HF and chronic insomnia; and (c) identify the associations between sleep characteristics, mood and somatic symptoms, and self-care maintenance and confidence among people with stable HF and chronic insomnia. METHODS: We utilized a cross-sectional design with 195 adult participants who had chronic HF and insomnia. We assessed for symptoms of anxiety; depression; dyspnea; fatigue; stress; insomnia severity; and sleep disturbance, impairment, and quality. Self-care was measured using the Self-Care for Heart Failure Index v6.2. We used generalized linear models to test the associations between the demographic and clinical factors and self-care maintenance and confidence; exploratory and confirmatory factor analysis to identify the factor structure underlying the symptoms; and structural equation modeling to test the combined associations of the demographic and clinical factors and latent factors with self-care maintenance and confidence. RESULTS: Self-care maintenance, confidence, and management were inadequate in most participants. We identified three latent factors among the nine symptoms: "sleep characteristics," "mood," and "somatic symptoms." In the structural equation model, "sleep characteristics," White race, and having a left ventricular ejection fraction of <45 were associated with self-care maintenance. Age was negatively associated with self-care confidence. DISCUSSION: Poor sleep characteristics negatively influence the ability of people with HF and insomnia to perform self-care behaviors. Knowledge of the associations among age, left ventricular ejection fraction, and race with self-care will help clinicians and future researchers identify those at risk for poor self-care.

A Focus Group Study of Retirement-Age Nurses: Balancing Tension and a Love of Nursing in a Changing Healthcare Environment.

OBJECTIVE: The aims of this study were to explore the experience of retirement-age nurses and identify decision-making factors and innovations to enhance retention. BACKGROUND: A national shortage of nurses has created challenges to preserving quality patient care and level of nursing competency and managing turnover costs. METHODS: A qualitative study using focus groups was conducted of nurses 55 years or older who were working or recently retired. Data were audiotaped and transcribed verbatim, with content analysis used to code in an iterative process until consensus was reached. RESULTS: The tension of balancing the love of patient care within a changing healthcare system was described. Patient acuity, competing roles, and the centrality of computers were stressors and integrally related. Flexibility in work schedules and new practice models were important to retirement decision making for work-life balance and retention. CONCLUSION: Passion for patient care dominated decisions to continue working. Innovations in practice models and scheduling offer opportunities to enhance the retention of experienced nurses.

Perceived Stress, Subjective, and Objective Symptoms of Disturbed Sleep in Men and Women with Stable Heart Failure.

Objective/Background: Sleep disturbance is prevalent among patients with heart failure (HF) and is associated with increased morbidity and mortality. Stress also affects health and quality of life among patients with cardiovascular disease and likely plays a prominent role in HF. However, little is known about the associations between stress and sleep among HF patients.Participants: One hundred fifty-three stable New York Heart Association (NYHA) Classification I-IV HF patients with at least low symptoms of insomnia (Mage:63.0 ± 12.8, 42% Women).Methods: We examined baseline stress, sleep disturbance, and sleep-related characteristics from a randomized controlled trial of cognitive behavioral therapy for insomnia, including the Perceived Stress Scale, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Sleep Disturbance Questionnaire, Dysfunctional Beliefs about Sleep Scale, PROMIS Cognitive Ability, SF-36 Mental Health, and wrist actigraphy. We used Pearson correlations and general linear models to assess stress-sleep associations, including the potential moderating effects of sex and symptom severity (NYHA).Results: There were moderate-to-large correlations between stress and self-reported sleep disturbance, dysfunctional beliefs about sleep, cognitive ability, and mental health (p's < 0.01). High stress was associated with more objectively-measured (i.e., actigraph-assessed) awakenings and sleep fragmentation among women than men (ß = - 0.04, p < 0.01; ß = - 0.71, p = 0.04). Relationships between stress and objectively-measured sleep did not vary by symptom severity.Conclusions: Perceived stress is related to sleep disturbance among HF patients, and effects may be sex-dependent. Subsequent research should determine the temporal links between sleep and stress, and optimal opportunities for intervention among HF patients.

Day-to-day Relationships between Physical Activity and Sleep Characteristics among People with Heart Failure and Insomnia.

OBJECTIVE: Examine the bidirectional relationships between within-person day-to-day fluctuations in physical activity (PA) and sleep characteristics among people with heart failure (HF) and insomnia. PARTICIPANTS: Ninety-seven community-dwelling adults [median age 61.9 (interquartile range 55.3,70.9) years, female 41%] with stable HF and insomnia (insomnia severity index >7). METHODS: This sub-study longitudinally analyzed 15 consecutive days and nights of wrist actigraphy recordings, that were collected for baseline data prior to participation in a randomized controlled trial of cognitive behavioral therapy for insomnia. We used two-level mixed models of within- (daily) and between-participants variation to predict daytime PA counts/minutes from sleep variables (total sleep time, sleep efficiency) and predict sleep variables from PA. RESULTS: PA counts/minutes were low compared to prior cohorts that did not have HF (209 (166,259)) and negatively associated with NYHA class (standardized coefficient ßs = -0.14, p < .01), age (ßs = -0.13, p = .01), comorbidities (ßs = -0.19, p < .01), and body mass index (ßs = -0.12, p = .04). After adjustment for all significant covariates, the within-participant association of total sleep time with next-day PA was estimated to be positive among participants with NYHA class II-IV HF (ßs = 0.09, p = .01), while the within-participant association of PA with same-night total sleep time was estimated to be positive among participants aged ≥60 years (ßs = 0.10, p = .03). CONCLUSIONS: Depending upon age and HF class, daytime PA was associated with longer same-night sleep and/or longer sleep was associated with greater next-day PA. Among those with more advanced HF, realistic sleep improvements were associated with clinically meaningful PA gains the next day.

Perspectives of Patients With Relapsed and Refractory Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome on Patient-Clinician Communication About Prognosis and the Future.

Background: Patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) experience unpredictable disease trajectories and high prognostic uncertainty, which serve as barriers to patient-clinician communication about prognosis and their values and preferences for the future in the event of worsening health. Little is known about patients' day-to-day lived experiences and how this shapes their willingness to engage in such conversations. Objectives: To explore participant perspectives on living with their illness and patient-clinician communication about prognosis and the future. Design: This is a qualitative study using semi-structured interviews. Setting/Subjects: Patients with relapsed and refractory (R/R) AML and high-risk MDS from a northeastern U.S. cancer center. Data Collection: Interviews were transcribed verbatim and thematic analysis was used to generate findings. Results: Of the 14 participants, the mean age was 66 years, 79% were men, 93% were White, married, and had AML. The overarching theme that describes the experience was "Taking One Day at a Time" in a Fog of Uncertainty. Uncertainty was a universal perception related to the challenges for clinicians to predict prognosis. To cope with uncertainty, most participants tried to focus on the present and maintain normality in everyday life. Participants valued encouragement and positivity in patient-clinician communication, however, the majority were not ready to discuss prognosis and the future in the event of worsening health. Of note, 7 of 14 participants died within three months after the interview. Conclusions: These data describe a unique perspective of patients with R/R AML and high-risk MDS that clinicians could use to enhance communication strategies.

Investigating brain dynamics and their association with cognitive control in opioid use disorder using naturalistic and drug cue paradigms.

Objectives: Opioid use disorder (OUD) impacts millions of people worldwide. The prevalence and debilitating effects of OUD present a pressing need to understand its neural mechanisms to provide more targeted interventions. Prior studies have linked altered functioning in large-scale brain networks with clinical symptoms and outcomes in OUD. However, these investigations often do not consider how brain responses change over time. Time-varying brain network engagement can convey clinically relevant information not captured by static brain measures. Methods: We investigated brain dynamic alterations in individuals with OUD by applying a new multivariate computational framework to movie-watching (i.e., naturalistic; N=76) and task-based (N=70) fMRI. We further probed the associations between cognitive control and brain dynamics during a separate drug cue paradigm in individuals with OUD. Results: Compared to healthy controls (N=97), individuals with OUD showed decreased variability in the engagement of recurring brain states during movie-watching. We also found that worse cognitive control was linked to decreased variability during the rest period when no opioid-related stimuli were present. Conclusions: These findings suggest that individuals with OUD may experience greater difficulty in effectively engaging brain networks in response to evolving internal or external demands. Such inflexibility may contribute to aberrant response inhibition and biased attention toward opioid-related stimuli, two hallmark characteristics of OUD. By incorporating temporal information, the current study introduces novel information about how brain dynamics are altered in individuals with OUD and their behavioral implications.

Coping, symptoms, and insomnia among people with heart failure during the COVID-19 pandemic.

AIMS: Increases in stress, symptoms of anxiety and depression, and sleep problems have been reported during the Covid-19 pandemic, and people with chronic medical conditions such as heart failure (HF) are especially vulnerable. The purpose of this study was to examine the extent to which sleep characteristics, sleep-related cognitions, anxiety, depression, perceived stress, and changes in these phenomena over time predict ways of coping with pandemic-related stress among participants in the HeartSleep study, a randomized controlled trial of the effects of cognitive behavioural therapy for insomnia (CBT-I) in people with HF. METHODS AND RESULTS: Participants completed questionnaires to elicit sleep characteristics, daytime symptoms, mood and stress at baseline, 6 months after the intervention and during the Covid-19 pandemic. We added measures of coping during the pandemic (June-August 2020). The sample included 112 participants (M age = 63 ± 12.9 years; 47% women; 13% Black; 68% NY Heart Class II or III). Participants (43%) reported pandemic-related stressors and most often used secondary control coping. Insomnia severity, anxiety, depression, perceived stress, and sleep-related cognitions predicted secondary control coping (positive thinking, cognitive restructuring, acceptance, distraction), involuntary engagement (physiological arousal, rumination), and involuntary disengagement (emotional numbing). CONCLUSIONS: Insomnia and mood disturbance are important determinants of coping and responses to stress. Improving sleep and symptoms among people with HF may improve coping during stressful events, and CBT-I may have protective effects. REGISTRATION: ClinicalTrials.gov: NCT02660385.

Integrating Palliative Care Into Self-management of Breast Cancer: A Pilot Randomized Controlled Trial.

BACKGROUND: Breast cancer patients may not be well-informed about palliative care, hindering its integration into cancer self-management. OBJECTIVE: The aim of this study was to test Managing Cancer Care: A Personal Guide (MCC-PT), an intervention to improve palliative care literacy and cancer self-management. METHODS: This was a single-blind pilot randomized controlled trial to evaluate the feasibility/acceptability and intervention effects of MCC-PT on palliative care literacy, self-management behaviors/emotions, and moderation by demographic/clinical characteristics. We enrolled 71 stages I to IV breast cancer patients aged at least 21 years, with >6-month prognosis at an academic cancer center. Patients were randomized to MCC-PT (n = 32) versus symptom management education as attention-control (n = 39). At baseline, 1 month, and 3 months, participants completed the Knowledge of Care Options Test (primary outcome), Control Preferences Scale, Goals of Care Form, Medical Communication Competence Scale, Measurement of Transitions in Cancer Scale, Chronic Disease Self-efficacy Scale, Hospital Anxiety and Depression Scale, and the Mishel Uncertainty in Illness Scale. RESULTS: Mean participant age was 51.5 years (range, 28-74 years); 53.5% were racial/ethnic minority patients, and 40.8% had stage III/IV cancer. After adjusting for race/ethnicity, MCC-PT users improved their palliative care literacy with a large effect size (partial η2 = 0.13). Patients at late stage of disease showed increased self-management (partial η2 = 0.05) and reduced anxiety (partial η2 = 0.05) and depression (partial η2 = 0.07) with medium effect sizes. CONCLUSIONS: Managing Cancer Care: A Personal Guide is feasible and appears most effective in late-stage cancer. Research is needed to elucidate relationships among cancer stage, race/ethnicity, and self-management outcomes. IMPLICATIONS FOR PRACTICE: Integration of palliative care into cancer care can assist in creation of appropriate self-management plans and improve emotional outcomes.

Trajectory of self-care in people with stable heart failure and insomnia after two self-care interventions.

OBJECTIVE: To describe (1) self-care trajectories among adults with heart failure (HF) and insomnia over 1-year; (2) the extent to which trajectories varied between cognitive behavioral therapy for insomnia (CBT-I) or HF self-care intervention; and (3) the associations between self-care trajectories and clinical and demographic characteristics, sleep, symptoms and stress, and functional performance. METHODS: We conducted secondary analysis of data from a randomized controlled trial of the effects of CBT-I compared with HF self-care education among adults with stable HF and insomnia. We used the Self-Care of Heart Failure Index v6.2. The analytic approaches included t-tests, group-based trajectory modeling, ANOVA, and chi-square. RESULTS: We included 175 participants (M age=63.0 (12.9) years, White, N = 100]. We found four self-care trajectories: Low self-care (N = 47, 26.8%); Moderate self-care (N = 68, 38.9%): Adequate self-care (N = 42, 24.0%); and Optimal self-care (N = 18, 10.3%). There was no difference in self-care trajectories between interventions. The low self-care group had the most severe baseline fatigue, anxiety, and perceived stress, and lowest cognitive abilities. CONCLUSION: Both interventions prevented declining self-care. Future research is needed to determine the most efficacious intervention to improve self-care trajectories. PRACTICE IMPLICATIONS: Healthcare providers should provide ongoing self-care support for those with persistently low and moderate self-care.

Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study.

STUDY OBJECTIVES: Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized controlled trial (RCT) was to evaluate the sustained effects over one year of CBT-I (Healthy Sleep: HS) compared with HF self-management education (Healthy Hearts; attention control: HH) on insomnia severity, sleep characteristics, symptoms, and function among people with stable HF. The primary outcomes were insomnia severity, actigraph-recorded sleep efficiency, and fatigue. METHODS: We randomized adults with stable HF with preserved or reduced ejection fraction who had at least mild insomnia (Insomnia severity index >7) in groups to HS or HH (4 sessions/8 weeks). We obtained wrist actigraphy and measured insomnia severity, self-reported sleep characteristics, symptoms (fatigue, excessive daytime sleepiness, anxiety, depression), and six-minute walk distance at baseline, within one month of treatment, and at 6 and 12 months. We used general linear mixed models (GLMM) and generalized estimating equations (GEE) to evaluate the effects. RESULTS: The sample included 175 participants (M age = 63 ± 12.9 years; 43% women; 18% Black; 68% New York Heart Association Class II or II; 33%; LVEF < 45%) randomized to HS (n = 91) or HH (n = 84). HS had sustained effects on insomnia severity, sleep quality, self-reported sleep latency and efficiency, fatigue, excessive daytime sleepiness, and six-minute walk distance at 12 months. CONCLUSIONS: CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF, compared with a robust HF self-management program that included sleep hygiene education. CLINICAL TRIAL INFORMATION: Insomnia Self-Management in Heart Failure; https://clinicaltrials.gov/ct2/show/NCT02660385; NCT02660385.

Evaluating Recruitment Strategies for a Randomized Clinical Trial with Heart Failure Patients.

Recruiting participants with chronic medical conditions is time-consuming and expensive. Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods. We aimed to describe the yields, benefits, and limitations of recruitment strategies used for a randomized clinical trial of cognitive behavioral therapy for insomnia among patients with chronic stable heart failure (NCT02660385). We used multiple recruitment strategies including clinic-based recruitment, letters to patients identified from electronic databases, the patient portal, brochures and posters placed in clinics, presentations to heart failure support groups, and online advertising. We screened 10,291 medical records, enrolled 231 participants, and 195 participants completed baseline data collection. We enrolled 92 (23%) participants using clinic-based recruitment, 24 and 29 (6% and 10%) using letters to patients from two electronic databases, and 42 (55%) via the patient portal. Multiple recruitment strategies and flexibility are needed to achieve recruitment goals.

Knowledge of Cancer Stage among Women with Nonmetastatic Breast Cancer.

BACKGROUND: Discrepancies may exist between what oncologists communicate and what patients understand about their cancer stage and its implications. OBJECTIVE: We explored patients' ability to identify their stage of breast cancer. METHODS: As part of a study testing a cancer self-management intervention we asked women to identify their stage of disease and compared responses to the electronic medical record (EMR) for validation. The sample included women with recently diagnosed nonmetastatic (stage I-III) disease. We calculated descriptive statistics and used logistic regression to examine relationships between knowledge of stage, demographic and clinical variables, and study outcomes. Measurement instruments were the Control Preferences Scale (CPS), Knowledge of Care Options Test (KOCO), Measurement of Transitions Scale (MOT), Medical Communication Competence Scale (MCCS), Chronic Disease Self-Efficacy Scale (CDSE), Uncertainty in Illness Scale (MUIS-C), and Hospital Anxiety and Depression Scale (HADS). RESULTS: Participants (n = 98) had a mean age of 52.3 years (range 27-72). Per the EMR, 19 participants (19.4%) had stage I breast cancer, 56 (57.1%) had stage II, and 23 (23.5%) had stage III. Of the 28 participants (28.6%) unable to identify their stage of cancer correctly, 11 (39.3%) provided vague responses, 11 (39.3%) reported an incorrect stage, and 6 (21.4%) did not know their stage. Younger age (p = 0.0412) and earlier cancer stage (p = 0.0136) were predictive of correctly identifying stage. Participants who at baseline had a greater knowledge of care options (curative, palliative, and hospice care) were more likely to correctly identify their stage (KOCO, p = 0.0345). CONCLUSIONS: Clinicians should revisit conversations about cancer stage and care options to ensure patients' understanding and support self-management.

Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial.

BACKGROUND: Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patients' knowledge of palliative care and to facilitate its timely integration into cancer self-management. METHODS: Aims are to: 1) evaluate the effects of MCC on patients' knowledge of palliative care; 2) examine preliminary effects of MCC on patients' behaviors (role in self-management, engagement in goals of care conversations, medical communication, management of transitions, health care utilization), and feelings (self-efficacy, anxiety, depression, uncertainty); and 3) evaluate protocol feasibility and acceptability. An exploratory aim is to investigate how demographic and clinical factors may moderate intervention effects, with emphasis on differences in use and outcomes among minority participants. We plan to enroll 60 patients and their family caregivers with 50% minority participation. The intervention group receives MCC; the attention-control group receives a Symptom Management Toolkit. We collect data at baseline, one, and three months. DISCUSSION: This study will inform a large scale trial of MCC. It is challenging for patients with breast cancer, their family caregivers, and providers to make choices that include palliation alone or in combination with potentially curative treatment. MCC may help address this challenge by giving patients the information, skills, and confidence to better self-manage breast cancer. Results may help to establish palliative care as a mainstay of self-management interventions targeting serious illness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02148575 (date registered: 5.21.14; date first patient enrolled: 7.15.14).