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Objective: Evidence is scant regarding symptom clusters and quality of life (QOL) over 1 year in women who receive adjuvant breast cancer chemotherapy (CTX). Our purpose was to identify the prevalence and severity of individual symptoms, symptom clusters, and QOL in women receiving adjuvant breast cancer CTX from baseline over 1 year. Methods: Symptoms were identified in a sample (n = 219) at three times: baseline (prior to the first adjuvant CTX treatment), 1 month after the last CTX (approximately 6 months after baseline), and 1 year after baseline. The Hospital Anxiety and Depression Scale and Symptom Experience Scale measured symptoms. The Medical Outcomes Study, Short-Form Survey, measured QOL. Exploratory factor analysis identified symptom clusters at each time and core symptoms in clusters over time. Results: The prevalence and severity of 10 symptoms decreased over time (P < 0.05). Fatigue, sleep disturbance, and pain were most prevalent; all were of mild severity. Two symptom clusters were identified at baseline and one met internal consistency reliability criteria at the later times. Core symptoms were identified. Both the physical and mental component scores of QOL improved over time (P < 0.01), but physical was below the general population norms 1 year after baseline. Conclusions: The symptom experience was dynamic, and symptom clusters changed over 1 year. Despite mild severity, core symptoms and clusters persisted over 1 year, and physical health was below the general population norms. Breast cancer survivors with persistent single and co-occurring symptoms need to be taught to manage the patterns of symptoms over time because they may not resolve by 1 year.

To examine if selected demographic (age, gender), clinical (diabetes, coronary artery disease, hyperlipidemia, myocardial infarction, stroke, lung disease, smoking history, alcohol intake), and biomarker [blood pressure (BP), heart rate, body mass index (BMI), neck circumference, Mallampati score] variables are predictors of apnea-hypopnea index (AHI) from polysomnography (PSG). This cross-sectional study recruited a sample of adults (N = 170) who were being evaluated for OSA. Participants completed self-reported demographic and clinical questionnaires, and then completed PSG (n = 142). Multi-collinearity was assessed. Confounding factors, correlations, and potential interactions were explored. The final regression model was performed on 130 participants; 61 (46.9%) had an AHI ≥ 15. Systolic and diastolic BPs were highly correlated. Interactions were tested between gender and other variables (high cholesterol, BMI, neck circumference, systolic BP) and between systolic BP and other variables (high cholesterol, BMI, neck circumference, and lung disease). No interactions occurred between gender or systolic BP and other variables, meaning that the effects of the variables on AHI levels from PSG did not vary depending on gender or systolic BP. BMI, systolic BP, and absence of lung disease were predictors for AHI levels ≥ 15 from PSG. BMI and systolic BP were significant predictors of OSA in this study. The absence of lung disease as a significant predictor was unique and may be due to the small number of participants who self-reported lung disease. To our knowledge, this is the first study to report this combination of variables to predict AHI levels ≥ 15 from PSG.

Fatigue is the most reported and most distressing symptom among patients with cancer. However, no questionnaire that measures fatigue and fatigue interference with life has been translated into Arabic.This study aimed to translate and validate the Arabic version of the Brief Fatigue Inventory (BFI-A).The BFI was translated into Arabic using the forward-backward translation technique. This cross-sectional study collected data from cancer patients through a self-administered questionnaire that included the BFI-A, Insomnia Severity Index (ISI), Zung Depression Scale (ZDS), MD Anderson Symptom Inventory total score (MDASI), and Medical Outcome Study Short Form 36 (SF-36) Vitality Subscale. Descriptive and inferential statistics were used including mean, standard deviation, internal consistency, and correlation coefficient using Pearson's correlation.A total of 79 patients were recruited in Amman, Jordan, in 2015. Mean of the total BFI-A was 4.01 (2.4), showing that 83.5% had nonsevere fatigue. Cronbach's α coefficient of the BFI-A was 0.93. The correlations between total BFI-A scores and BFI-A items were significant (P0.05) and ranged from 0.75 to 0.86. BFI-A showed a significant correlation (P0.05) with the following tools: ISI = 0.70, ZDS = 0.69, MDASI = 0.75, and SF-36 Vitality Subscale = -0.57.This study suggests that the BFI-A is a reliable and valid tool to assess fatigue among Arab cancer patients.دراسة للتحقق من النسخة العربية لمقياس التعب الوجيز (BFI–A).خالد سليمان، محمود الكلالدة، لؤي أبو شحرور، برنيس ييتس، آن بيرجر، تيتو مندوزا، ملكة ملك، أيمن بني سلامة، شارلز كليلاند، أحمد المنشاوي.يُعدّ التعب أكثر الأعراض التي يشكو منها مرضى السرطان وأكثرها تكديراً لهم. ومع ذلك، لم يُترجَم إلى اللغة العربية أي استبيان يقيس التعب ومدى إعاقته لحياة المريض.كانت هذه الدراسة تهدف إلى ترجمة "مقياس التعب الوجيز" (BFI-A) والتحقق من نسخته العربية.تُرجم المقياس إلى اللغة العربية بطريقة الترجمة المباشرة والعكسية. وجمعت هذه الدراسة المقطعية بيانات من مرضى السرطان من خلال استبيان ملأه المرضى بأنفسهم وتضمَّن "مقياس التعب الوجيز" (BFI-A)، و"مؤشر شدة الأرق" (ISI)، و"مقياس زونج للاكتئاب" (ZDS)، ومجموع درجات "قائمة أعراض" (MDASI)، و"المقياس الفرعي للحيوية في دراسة النتائج الطبية المختصرة المكونة من 36 بنداً" (SF-36). واستُخدمت إحصاءات وصفية واستنتاجية، منها المتوسط، والانحراف المعياري، والاتساق الداخلي، ومعامل الارتباط باستخدام ارتباط بيرسون.استعين اجمالا بتسعة وسبعين مريضا في مدينة عمان الاردنية عام 2015. وكان متوسط مجموع درجات « مقياس التعب الوجيز (BFI-A) هو 4.1)، مما يدل على ان 83.5٪ كانوا يعانون تعبا غير شديد. وكان معامل كرونباخ الفا لمقياس التعب الوجيز هو 0.93. وكانت علاقات الترابط بين مجموع درجات « مقياس التعب الوجيز » وبنود هذا المقياس علاقات وثيقة (0.05P)، وتراوحت من 0.75 الى 0.86. وتبين وجود ترابط وثيق (0.05P) بين « مقياس التعب الوجيز BFI-A)» والمقاييس التالية: مؤشر شدة الارق (0.70) (ISI)، ومقياس زونج للاكتئاب (0.69) (ZDS)، وقائمة الاعراض (0.75) (MDASI)، والمقياس الفرعي للحيوية في دراسة النتائج الطبية المختصره المكونه من 36 بندا (0.57-) (SF-36).تشير هذه الدراسة إلى أن (BFI-A) أداة موثوقة وصالحة لتقييم التعب لدى مرضى السرطان الناطقين بالعربية.Étude de validation de la version arabe du Brief Fatigue Inventory (BFI-A).La fatigue est le symptôme le plus fréquent et le plus éprouvant chez les patients atteints de cancer. Cependant, aucun questionnaire mesurant la fatigue et son interférence avec la vie quotidienne n’a été traduit en arabe.La présente étude visait à traduire et à valider la version arabe du Brief Fatigue Inventory (BFI-A).Le BFI a été traduit en arabe à l’aide de la technique de traduction/rétro-traduction. La présente étude transversale a permis de collecter des données de patients atteints de cancer en recourant à un auto-questionnaire comprenant le BFI-A, l’index de Sévérité de l’Insomnie (ISI), l’échelle d’auto-évaluation de la dépression de Zung (ZDS), l’inventaire des symptômes M.D. Anderson (MDASI) et la sous-échelle vitalité de la forme abrégée du questionnaire généraliste SF-36 (qualité de vie) du Medical Outcome Study. Des statistiques descriptives et inférentielles ont été utilisées, y compris la moyenne, l’écart type, la cohérence interne et le coefficient de corrélation de Pearson.79 patients au total ont été recrutés à Amman (Jordanie) en 2015. La moyenne totale du BFI-A était de 4,01 (2,4), indiquant que 83,5 % des patients présentaient un état de fatigue non sévère. Le coefficient alpha de Cronbach du BFI-A était de 0,93. Les corrélations entre les scores totaux et les rubriques du BFI-A étaient significatives (p0,05) et étaient comprises entre 0,75 et 0,86. Le BFI-A affichait une corrélation importante (p0,05) avec les instruments suivants : ISI = 0,70 ; ZDS = 0,69 ; MDASI = 0,75 et la sous-échelle vitalité du SF-36 (qualité de vie) = −0,57.La présente étude suggère que le BFI-A est un outil valable et fiable pour évaluer la fatigue chez les patients arabes atteints de cancer.

Purpose Hematopoietic stem cell transplant (HSCT) is an intensive treatment associated with distressing treatment and disease-related symptoms that affect patient outcomes such as functional status and quality of life. Self-efficacy for symptom management (SESM) is a person's belief in their ability to perform behaviors to prevent and relieve symptoms. Presence of SESM can impact symptom distress and functional status. This study describes the changes over time and relationships among SESM, symptom distress, and physical functional status in adults during the acute phase of HSCT. Methods Patients (n = 40) completed measures of symptom distress, SESM, and physical function at time points prior to and at days 7, 15 and 30 post-transplant. Clinical outcomes were length of stay and number of readmissions. Results Symptom distress, physical function, and SESM changed significantly over time. There was a significant negative relationship between symptom distress and physical function and between symptom distress and SESM at all points. The lowest levels of SESM and physical function were at day 7 when symptom distress was highest. Symptom distress was a moderator for the relationship between physical function and SESM at day 15. Conclusion This was the first study to examine SESM in the acute phase of HSCT. Higher SESM was associated with fewer symptoms and increased physical function. Less symptom distress was associated with higher physical function and confidence to manage symptoms. These findings provide the basis for development of patient-centered interventions to enhance SESM when symptoms are at their highest immediately after HSCT.

Objective: To examine glycemic variability within 1 month and 1 year following surgery among adult patients, with and without Type 2 Diabetes (T2D), treated for stage II-III colon cancer. Method: A retrospective analysis of electronic health record data was conducted. Glycemic variability (i.e., standard deviation [SD] and coefficient of variation [CV] of > 2 blood glucose measures) was assessed within 1 month and within 1 year following colon surgery. Chi-square (χ2), Fisher’s exact, and Mann-Whitney U tests were used for the analyses. Results: Among the sample of 165 patients with stage II–III colon cancer, those with T2D had higher glycemic variability compared to patients without T2D ( p < .001), with values within 1 month following surgery (SD = 44.69 mg/dL, CV = 27.4%) vs (SD = 20.55 mg/dL, CV = 17.53%); and within 1 year following surgery (SD = 45.04 mg/dL, CV = 29.04%) vs (SD = 21.36 mg/dL, CV = 18.6%). Associations were found between lower body mass index and higher glycemic variability (i.e., SD [r = −.413, p < .05] and CV [r = −.481, p < .01]) within 1 month following surgery in patients with T2D. Higher preoperative glucose was associated with higher glycemic variability (i.e., SD r = .448, p < .01) within 1 year in patients with T2D. Demographic and clinical characteristics were weakly associated with glycemic variability in patients without T2D. Conclusions: Patients with stage II–III colon cancer with T2D experienced higher glycemic variability within 1 month and within 1 year following surgery compared to those without T2D. Associations between glycemic variability and demographic and clinical characteristics differed by T2D status. Further research in prospective studies is warranted.

Psychoneurological symptom clusters are co-occurring and interrelated physiological symptoms that may include cancer-related fatigue, pain, depressive symptoms, cognitive disturbances, and sleep disturbances. These symptoms are hypothesized to share a common systemic proinflammatory etiology. Thus, an investigation of systemic immune biomarkers is an important approach to test this hypothesis. Here, we investigated the associations between extracellular vesicle (EV)-associated and soluble cytokines with immune markers and symptom clusters in men with non-metastatic prostate cancer. This observational study included 40 men with non-metastatic prostate cancer at the start (T1) of external beam radiation therapy (EBRT) and 3 months post treatment (T2), as well as 20 men with non-metastatic prostate cancer on active surveillance (AS) seen at one time point. Collected questionnaires assessed patient-reported fatigue, sleep disturbances, depressive symptoms, and cognitive fatigue. In total, 45 soluble and EV-associated biomarkers in plasma were determined by multiplex assays. Principal component analysis (PCA) was used to identify psychoneurological symptom clusters for each study group and their time points. Bivariate correlation analysis was run for each identified PCA cluster with the concentrations of EV-associated and soluble cytokines and immune markers. Both EV-associated and soluble forms of RANTES significantly correlated with the symptom cluster for EBRT at T1, whereas, at T2, soluble IFNα2, IL-9, and IL-17 correlated with the corresponding symptom cluster. For the AS group, soluble survivin correlated with psychoneurological symptoms. Linking specific inflammatory cytokines with psychoneurological symptom clusters in men receiving prostate cancer treatment can enhance understanding of the underlying mechanisms of this phenomenon and aid in developing targeted interventions.

Nurses are on the frontline of palliative care, and in some countries, are the only contact for patients and families facing life-threatening illness. The Oman Cancer Association in the Sultanate of Oman, in collaboration with the Middle Eastern Cancer Consortium and the Oncology Nursing Society, led a palliative care initiative over the past decade to better integrate palliative care into the health care system. Components of this initiative include integrating palliative care into the health care curricula and providing palliative care education to over 400 nurses and other health care professionals within Oman. The four-part education series includes the following courses: (1) Foundations of Palliative Care, (2) Advanced Concepts in Palliative Care, (3) Palliative Care Leadership, and (4) Palliative Care Research. Additional participants from 17 different countries in the Middle East and northern Africa also attended the training. Twenty of the trainees who were considered palliative care leaders in their countries then participated in a Train the Trainer course. This group trained the last cohort of health care professionals in Oman and then took learned concepts and strategies back to their respective countries in order to provide country-wide education and build palliative care capacity in the region. Outcomes include the development of palliative care units, quality improvement projects that improved care, and advocacy projects to increase opioid availability within some countries. The collaborative continues its work and connections through social medial, email, and virtual collaboration. Other countries can use this model to permeate palliative care within their regions.

Objective Neuroimaging studies of hematologic cancer patients report altered activity in dorsal attention and central executive networks. To determine the consequences of these altered brain networks, we evaluated neurophysiological correlates of attention and working memory in hematologic cancer patients prior to initiating treatment. Methods Hematologic cancer patients (19–80 years) were excluded for premorbid cognitive impairment, prior non-hematologic cancer diagnosis, and prior chemotherapy. Attention was manipulated by presenting an irrelevant spatial cue prior to visual search displays. Working memory was manipulated by presenting irrelevant distractors within memory displays. Electroencephalogram was recorded during task performance. Results Patients (n = 28) and controls (n = 15) were balanced on age, gender, and education. Spatial cues evoked larger N2pc amplitudes, a correlate of spatial attention, in patients than controls (p 0.7). Memory distractors evoked larger contralateral delay activity amplitudes, a correlate of working memory load, in patients (p = .028; Cohen’s d = 1.1) but not controls (p = .64). Conclusions Prior to initiating treatment, hematologic cancer patients demonstrated poor control over spatial attention and working memory, consistent with altered dorsal attention and central executive network activity. Significance Hematologic cancer patients may be at a higher risk for selecting, processing, and storing distracting information that would compete with more immediate goal-related behaviors.

Throughout the cancer continuum, patients are faced with the cancer- and treatment-related side effects that can have a negative impact on their overall quality of life. Cancer-related fatigue (CRF) and sleep deficiency are among the symptoms that patients and their caregivers most often experience. An increasing body of literature suggests that a strong correlation between CRF and sleep deficiency exists, indicating that they may be reciprocally related and that they may have similar underlying etiology. This paper aims at bringing together the opinions of leading cancer control (i.e., CRF and sleep) and oncology experts in order to increase the understanding of CRF and sleep deficiency's assessment, associated symptom clustering, symptom burden shared by caregivers, and CRF and sleep deficiency management in the cancer care context.

Problem identification Self-efficacy for symptom management plays a key role in outcomes, such as quality of life (QOL), functional status, and symptom distress, for adults with cancer. This integrative review identified and assessed evidence regarding self-efficacy for management of symptoms and symptom distress in adults with cancer. Literature search The authors performed a search of literature published from 2006-2018, and articles that examined the relationship among self-reported self-efficacy, symptom management, symptom distress or frequency, and severity in adults with cancer were selected for inclusion. Data evaluation 22 articles met the inclusion criteria. All articles were critically appraised and met standards for methodologic quality. Synthesis Evidence from this review showed that high self-efficacy was associated with low symptom occurrence and symptom distress and higher general health and QOL. High self-efficacy predicted physical and emotional well-being. Low self-efficacy was associated with higher symptom severity, poorer outcomes, and better overall functioning. Implications for research Self-efficacy can be assessed using developed instruments. Presence of a theoretical model and validated instruments to measure self-efficacy for symptom management have set the groundwork for ongoing research.

Introduction: Introduction Sleep disturbances are common in adolescents with neurodevelopmental disorders (NDDs). Inclusion of vulnerable populations such as adolescents with NDDs into sleep intervention efforts is essential as they are at high-risk for poor physical/mental health outcomes. The objective of this study is to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on treatment response, to optimize sleep health in adolescents with NDDs. Methods: Methods Recruitment began June 2019 using convenience sampling. The SMART pilot feasibility study includes 1-week of baseline sleep data, and two 4-week periods of a sleep intervention (9-week total study enrollment). Interventions include exogenous melatonin, The Bedtime Bank, and their combination. Exogenous melatonin (liquid, immediate release, 3mg) is administered 30 minutes before bedtime. The Bedtime Bank, a behavioral sleep intervention, is based upon contingency contracting that relies on a credit- or debt-based system to hold adolescents accountable for maintaining a consistent bedtime. At baseline participants completed demographics, PROMIS pediatric sleep questionnaires, the Cleveland Adolescent Sleepiness Questionnaire (CASQ), salivary & urinary endogenous melatonin measurement, and one week of actigraphy. Upon enrollment, participants were randomly assigned to either melatonin or The Bedtime Bank. Participants who respond (nightly increase in total sleep time (TST) ≥18 minutes) remain on the assigned intervention; if non-responsive participants are re-randomized to a different sleep intervention or combination. Results: Results At baseline, participants (n=29, aged 10–18 years) had an average TST of 7 hours 11 minutes. PROMIS Sleep Disturbance (M=64.3, SE=2.5), PROMIS Sleep-Related Impairment scores (M=58.9, SE=2.2), and CASQ scores (M=40.0, SD= 10.5) were higher than reported normative values. Salivary DLMO & urinary 6-sulfatoyxmelatonin analysis is ongoing. For participants who completed the full 9-week trial, nearly 30% (n=7/24) were responsive (increased baseline TST ≥18 minutes) to one of the 4-week interventions. Conclusion: Conclusion Baseline data of the enrolled participants demonstrates poor indicators of TST, sleep disturbance, and sleep related impairment. Preliminary results of this SMART indicate some adolescents are responsive to sleep interventions aimed to improve their TST. Support (if any) Support: This clinical trial is funded by the National Institute of Nursing Research, National Institutes of Health (1K01NR017465-01A1).

We describe a mixed qualitative and quantitative research study in a military facility regarding the role of nature in well-being. Study intervention included two 20-minute walks. One walk was in an intentionally designed woodland environment (Green Road) and the other was on a busy campus road in a medical treatment facility (Urban Road). Twelve volunteers from a military facility participated in both walks in a cross-over experimental design. The two walking sessions were randomly ordered and preceded by pre-walk instructions appropriate to each road’s characteristics and incorporated focused attention and present moment orientation. A semi-structured post-walk interview, the primary outcome, was conducted after the conclusion of each walk. Qualitative data analyses consisted of sentiments and themes by using NVivo 12 software. The Green Road was unanimously rated as positive (100%). Responses to Urban Road were evenly distributed among positive (33.3%), negative (33.3%), and neutral/mixed (33.3%) sentiments. The Green Road yielded predominantly positive themes such as enjoyment of nature, relaxation, and feelings of privacy and safety. Urban Road produced significantly more negative themes such as concerns for safety, dislike of noise and other noxious experiences. Quantitative assessment of distress and mindfulness with Distress Thermometer (DT) and Mindful Attention Awareness Scale-state version (MAAS) demonstrated that a walk on the Green Road significantly decreased distress and increased mindfulness compared to a walk on the Urban Road. We also observed that pre-walk instructions could direct attention to both obvious and subtle elements of experience and enhance awareness. Results support the notion that an intentional nature-based environment may produce significantly more positive experiences and result in health-promoting benefits in a military health-care setting compared to an urban environment. Future studies with clinical populations could advance our understanding of the healing value of nature-based interventions. The impact of intentional green environments may be enhanced by well-designed instructions for both recreational and therapeutic use.

Sleep deficiency is common and distressing for women with breast cancer throughout the care continuum. This article describes the scope and quality of evidence related to exercise interventions to improve sleep in women with breast cancer. Fifteen studies met the criteria and 12 were judged to be excellent quality. The most frequent intervention was walking, primarily during the time of chemotherapy. Eleven studies reported postintervention improvement in sleep deficiency. Most yoga, qigong, and dance intervention studies reported no differences between groups. Emerging evidence exists for the effectiveness of aerobic exercise to improve various sleep outcomes in women with breast cancer.

Introduction Promoting cessation services like quitlines is important to reduce tobacco-related morbidity and mortality. A critical need exists to improve clinical staff's awareness of tobacco quitlines and reduce barriers in recommending and referring tobacco-using patients. The purpose was to obtain information on the use of the Nebraska Tobacco Quitline (NTQ) by Federally Qualified Health Center (FQHC) clinical staff at FQHC settings with tobacco-using patients. Specific aims were: 1) identify FQHC clinical staff and setting characteristics that influence current tobacco cessation assessment and interventions, and 2) identify barriers and facilitators that influence future use of NTQ by FQHC clinical staff and settings. Methods This study recruited participants from seven FQHC settings. All FQHC provider and non-provider clinical staff were recruited to complete a Clinical Staff Survey. The Medical Director, Associate Medical Director, or Nurse Manager at each FQHC was asked to provide setting information through the Setting Survey. Descriptive statistics were used to report percentages and qualitative data were analyzed using pattern coding. Results The main findings include insufficient awareness and insufficient perceived effectiveness of NTQ, non-providers reporting a limited role in tobacco cessation efforts beyond assessment of tobacco use, and the lack of supportive setting processes for intervention use. Conclusions Targeted efforts are needed to increase awareness and perceived effectiveness of NTQ, for role expansion for non-providers, and to add Electronic Health Record (EHR) prompts and e-referral capability to increase cessation interventions including NTQ referrals. Future research is suggested to better understand patient-specific barriers in using NTQ.

Background New or worsening sleep-wake disturbance (SWD) can occur throughout the cancer trajectory. . Objectives The purpose of this article is to critically review available empirical evidence supporting the efficacy of interventions for SWD, highlighting new evidence since the 2006 and 2009 Putting Evidence Into Practice (PEP) SWD publications. . Methods A systematic review of studies published from 2009-2017 was conducted to identify effective interventions for cancer-related SWD. The PEP weight of evidence classification schema was used to categorize the strength of evidence. . Findings Cognitive behavioral intervention/approach is the only intervention that is recommended for practice. Mindfulness-based stress reduction and exercise interventions are likely to be effective but require more evidence. Pharmacologic interventions, relaxation, imagery, meditation, acupuncture, yoga, massage, and psychoeducation have insufficient evidence.

Adverse drug events (ADEs) impact the health and safety of older adults. ADEs may lead to unplanned medical visits that influence health and related costs. The purpose of this study was to explore ADEs reported by rural, community-dwelling older adults. Data were collected on 138 participants' demographics, physical and mental health, sleep, medications, and ADEs. One or more ADEs were reported by 48% of participants, including central nervous symptom disturbances (16%), dry mouth (12%), hoarseness, gastrointestinal irritation, and decreased libido (all 8%). Poor sleep and poor physical health were associated with higher reported ADEs (p 0.05). Older adults (ages 79-99) and those with higher physical health were 60% less likely to report ADEs. Those with poorer sleep quality were 50% more likely to report ADEs. Viable strategies are needed to monitor and reduce ADEs in community-dwelling older adults who use multiple medications to manage poor health and poor sleep.

7021 Background: GA can predict the risk of toxicities of chemotherapy in older adults. Genetic risk categories correlate with OS in AML. We previously reported a reduction in early mortality in a pre-planned interim analysis of a phase II trial with the use of GA and genetic profiling to personalize therapy selection (NCT03226418) (Blood 2019; 134(s1):120). Here, we present the results of a propensity score matched analysis demonstrating an improvement in OS over a historical control. Methods: Patients ≥60 years with a new diagnosis of AML underwent GA. Patients were considered fit for intensive chemotherapy if they had robust physical function [normal activities of daily living (ADL) and instrumental ADL, and short physical performance battery score of ≥10 out of 12], normal cognitive function (Montreal Cognitive Assessment score of ≥26 out of 30), and hematopoietic cell transplantation comorbidity index (HCT CI) of 0-2 (except for treatment related AML, where a score of 0-2 in addition to the prior history of malignancy was acceptable). Genetic profiling for therapy selection relied on karyotyping and followed the 2017 ELN criteria. Fit patients with good or intermediate-risk AML received intensive chemotherapy. Patients with high-risk AML received low-intensity chemotherapy, or CPX 351 if they were fit and met the FDA-approved indications. Pragmatic aspects of the trial included broad eligibility criteria (e.g. patients on treatment for other malignancy were enrolled) and co-management of patients with community oncologists. Mortality was compared with a historical control treated during the years 2004-2016 (after approval of HMA) and matched on gender, age, Karnofsky Performance Status (KPS), HCT CI and ELN risk category. Results: Treatment group (n = 27) vs. historical controls (n = 32) were matched in terms of age (median age, 70 vs. 68.5 years), ELN risk category (adverse risk 59% vs. 53%), HCT CI (median score of 2), KPS (median 80 vs. 85), and gender (male 44% vs. 50%). In the treatment group, 3 patients received intensive chemotherapy: CPX 351 (n = 2) or 7+3+ gemtuzumab (n = 1). Other patients received HMA alone (n = 16), decitabine and midostaurin (n = 3), or azacitidine and venetoclax after the approval of venetoclax (n = 5). Treatment in the historical control included intensive chemotherapy (n = 20) such as 7+3, or mostly HMA based low intensity chemotherapy (n = 12). OS was significantly higher in the treatment group over historical control with 1-year OS of 66% (95% CI 60-87%) vs. 16% (95% CI 7-35%). Conclusions: Our model to personalize AML therapy selection represents an innovative approach to precision medicine that incorporates both GA for patient profiling and genetic profiling of leukemia cells. Our results appear promising with superior OS (an absolute difference of 50% in 1-year OS) compared to a matched historical control. Clinical trial information: NCT03226418.

BackgroundFatigue is a consistently reported, severe symptom among patients with gliomas throughout the disease trajectory. Genomic pathways associated with fatigue in glioma patients have yet to be identified.MethodsClinical factors (performance status, tumor details, age, gender) were collected by chart review on glioma patients with fatigue (“I have lack of energy” on Functional Assessment of Cancer Therapy-Brain), as well as available genotyping data. Candidate genes in clock and inflammatory pathways were identified from a literature review, of which 50 single nucleotide polymorphisms (SNPs) in 7 genes were available. Clinical factors and SNPs identified by univariate analyses were included in a multivariate model for moderate-severe fatigue.ResultsThe study included 176 patients (median age = 47 years, 67% males). Moderate-severe fatigue was reported by 43%. Results from multivariate analysis revealed poor performance status and 2 SNPs were associated with fatigue severity. Moderate-severe fatigue was more common in patients with poor performance status (OR = 3.52, P < .01). For each additional copy of the minor allele in rs934945 (PER2) the odds of fatigue decreased (OR = 0.51, P < .05). For each additional copy of the minor allele in rs922270 (ARTNL2) the odds of fatigue increased (OR = 2.38, P < .01). Both of these genes are important in the circadian clock pathway, which has been implicated in diurnal preference, and duration and quality of sleep. No genes in the inflammatory pathway were associated with fatigue in the current study.ConclusionsIdentifying patients at highest risk for fatigue during treatment allows for improved clinical monitoring and enrichment of patient selection for clinical trials.

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder and contributes to increased morbidity and compromised cardiovascular outcomes. Sleep disorders are common but rarely reported and addressed by primary health providers. An American Academy of Sleep Medicine task force (2015) released quality measures for the care of adult patients with OSA; the first outcome is improved detection and categorization of OSA symptoms and severity to promote assessment and diagnosis of the disorder. This state of the science integrative review aimed to evaluate the screening and assessment for OSA in primary care settings including the psychometric properties of OSA screening measures. Studies that met inclusion criteria were fourteen non-experimental and three experimental designs. OSA screening measurements (Berlin questionnaire, Epworth sleepiness scale, STOP Bang) with extensive validation studies were examined. Conclusions are that the current practice model of screening and assessment for OSA in primary care is fragmented and ineffective. Primary care providers encounter patients with OSA symptoms but do not routinely screen, assess, or refer to a sleep specialist. More psychometric research is needed for the OSA screening measurements in primary care. The results of these studies can be translated into practice to increase detection of OSA.

Background: Oxidative stress is associated with poor perinatal outcomes. Little is known regarding the longitudinal levels of oxidative stress in the perinatal period or the correlation between maternal and neonatal oxidative stress levels. Objective: Describe and compare oxidative stress, specifically superoxide, superoxide dismutase, catalase, and glutathione levels, over the perinatal period. Study Design: Longitudinal descriptive design using a convenience sample of medically high- and low-risk pregnant women ( n = 140) from a maternal–fetal medicine and general obstetrics practice, respectively. Blood was obtained from women at 12–20 and 24–28 weeks’ gestation and during labor, from the umbilical cord at birth, and from neonates at 24–72 hr after birth. Levels of superoxide were measured using electron paramagnetic resonance (EPR) spectroscopy; antioxidants (superoxide dismutase, catalase, and glutathione) were measured using commercial assay kits. Relationships between oxidative stress levels at different time points were examined using nonparametric methods. Pregnancy outcome was collected. Results: Demographic variables, outcome variables, and oxidative stress levels in maternal blood, cord blood, and infants differed between medically high- and low-risk women. Descriptive patterns for oxidative stress measures varied over time and between risk groups. Significant correlations between time points were noted, suggesting intraindividual consistency may exist throughout the perinatal period. However, these correlations were not consistent across each medical risk group. Conclusion: EPR spectroscopy is a feasible method for the perinatal population. Results provide new information on perinatal circulating superoxide levels and warrant further investigation into potential relationships between prenatal and neonatal physiologic dysregulation of oxidative stress.

Introduction: Women diagnosed with breast cancer (BC) are at increased risk of sleep deficiency. Approximately 30–60% of these women report poor sleep during and following surgery, chemotherapy, radiation therapy, and anti-estrogen therapy. The purpose of this study was to examine the relationship between genetic variation in circadian rhythm genes and self-reported sleep quality in women with BC.Methods: This cross-sectional study recruited women with a first diagnosis of breast cancer at five sites in Nebraska and South Dakota. Sixty women were included in the study. Twenty-six circadian genes were selected for exome sequencing using the Nextera Rapid Capture Expanded Exome kit. 414 variants had a minor allele frequency of ≥5% and were included in the exploratory analysis. The association between Pittsburgh Sleep Quality Index (PSQI) score and genetic variants was determined by two-sample t-test or ANOVA.Results: Twenty-five variants were associated with the PSQI score at p < 0.10, of which 19 were significant at p

Cancer-related fatigue (CRF) is an important public health issue that involves millions of community-dwelling cancer survivors. CRF is the most debilitating patient reported symptom related to cancer therapies and exacts a significant economic and social toll. It adversely impacts patients' work, social relationships, and overall quality of life. CRF prevalence ranges from 30% to 90% during therapy and often persists months and years afterwards. This policy analysis examines the problem of lack of patient access to evidence-based nonpharmacologic CRF therapies. The authors use a five-step process described by Teitelbaum & Wilenski (2017) to address the problem statement, identify key stakeholders, explore problem landscape, describe two viable policy options, and make a recommendation. The two policy options considered were: (a) insurer reimbursements modeled after existing cardiac rehabilitation programs and (b) health care provider incentives that incorporate the oncology care model (OCM) quality measure. Advantages and disadvantages of both options are presented. Public health nurses are uniquely positioned in their communities to advocate for these changes to improve population health.

Background Hematopoietic stem cell transplantation (HSCT) is an intensive treatment that offers the potential for longer life or cure for some types of cancer. Hematopoietic stem cell transplant is associated with decreased quality of life and functional status and distressing symptoms. Self-efficacy for symptom management (SESM) is a person's belief in his/her ability to implement behaviors to manage these symptoms. Presence of SESM can affect symptom distress, healthcare utilization, and posttransplantation outcomes. Objective The aim of this study was to explore the meaning of SESM in adults during the acute phase of HSCT. Methods Interviews were conducted before and at 30 days after transplantation. Descriptive thematic analysis was performed on verbatim interview transcripts. Results Themes of confidence, being responsible, and caring for mind, body, and spirit were identified, with subthemes of self-confidence, confidence in others, confidence and symptom level, vigilance, self-advocacy, and normalcy. Participants reported having high SESM before transplantation and having much less or no SESM when symptom distress was the most severe. Conclusions This is the first study to examine the patient's perspective of self-efficacy in the acute phase of HSCT. This contributes to existing literature on the concept of symptom management and expands nursing knowledge of SESM in patients undergoing HSCT. Implications for practice Nurses can assess SESM before transplantation and implement interventions to enhance SESM when symptoms are at their most distressing after HSCT. The findings from this study can provide the basis for creating behavioral interventions to enhance self-efficacy for symptom management in HSCT patients.

Background: Many chronic conditions, including heart disease, cancer, and rheumatoid arthritis, are associated with underlying chronic inflammatory processes. Literature reviews have analyzed a variety of integrative therapies and their relationships with chronic inflammation. This systematic review is unique in reporting solely on yoga’s relationship with inflammation. Its purpose was to synthesize current literature examining the impact of yoga interventions on inflammatory biomarkers in adults with chronic inflammatory–related disorders. Method: Searches of several electronic databases were conducted. Inclusion criteria were (a) English language, (b) sample age >18 years old, (c) yoga interventions involving postures with or without yoga breathing and/or meditation, and (d) measured inflammatory biomarkers. Results: The final review included 15 primary studies. Of these, seven were rated as excellent and eight as average or fair. There was considerable variability in yoga types, components, frequency, session length, intervention duration, and intensity. The most common biomarkers measured were interleukin-6 ( n = 11), C-reactive protein ( n = 10), and tumor necrosis factor ( n = 8). Most studies reported positive effects on inflammatory biomarkers ( n = 11) from baseline to post yoga intervention. Analysis of the dose showed higher total dose (>1,000 min) resulted in greater improvements in inflammation. Conclusion: This review suggests that yoga can be a viable intervention to reduce inflammation across a multitude of chronic conditions. Future studies with detailed descriptions of yoga interventions, measurement of new and well-established inflammatory biomarkers, and larger sample sizes are warranted to advance the science and corroborate results.

Glycemic variability is associated with risks for adverse events in patients with cancer. Several studies have evaluated the presence and impact of hyperglycemia and/or hypoglycemia in patients with cancer; however, few studies have evaluated glycemic variability. The purpose of this integrative review of studies in patients with gastrointestinal cancers was to investigate the presence and methods of reporting glycemic variability during and following treatments.A comprehensive review of the literature was conducted. PubMed, CINAHL, EMBASE, and Cochrane databases were searched for publications between 1/1/1969 and 7/24/2019. Studies of patients with gastrointestinal cancer following surgery, during treatment, and5 years following treatment were included and evaluated by cancer type and method of glucose and glycemic variability measurement.Among 1526 patients with gastrointestinal cancer across 19 studies, gastric and pancreatic cancers were most prevalent. Timing of glucose testing and methods of analyzing glycemic variability varied. Most analyses used the standard deviation or interquartile range. Glycemic variability was more prevalent among patients with Type 2 Diabetes and among those with pancreatic cancer. In some patients glycemic variability remained notable one year following surgery despite improvements in glycemic control.Patients with gastrointestinal cancer experience glycemic variability during and up to one year following treatment. There was heterogeneity in methods related to timing of testing and reporting glycemic variability among the 19 studies in this review. Future investigations need to identify the presence and define the methods of measuring glycemic variability in patients with gastrointestinal cancer.

Background: The role of oxidative stress remains unclear in the multifactorial pathophysiologic mechanism of lung disease in preterm infants. Aims: The aim of this study was to examine the associations among chronic lung disease (CLD), oxidative stress, and oxygen requirements in preterm infants. Design: Prospective, longitudinal, and correlational design. Subjects: Preterm infants born at Measurements: The diagnosis of CLD was obtained from the medical record. Oxidative stress was measured using 8-hydroxydeoxyguanosine (8-OHdG) in the cord blood at birth and urine on Days 1 and 7. Oxygen requirements were measured using fraction of inspired oxygen (FIO2) recorded in the first hour after birth/admission and the average FIO2 during the first 12 hr and 7 days after birth. Descriptive statistics are presented. Comparison analyses were performed using Kruskal–Wallis and Fisher’s exact tests. Results: Infants with CLD ( n = 12) had lower gestational age ( p = .04) and weight ( p = .04) at birth, more days on the ventilator ( p = .004), and longer neonatal intensive care unit stay ( p = .04) compared to infants without CLD ( n = 19). CLD was associated with lower oxidative stress levels ( p = .03) and higher oxygen requirements during the first 12 hr ( p = .025) and on Day 7 ( p = .001). Lower oxidative stress levels on Day 7 were associated with higher oxygen requirements in the first 12 hr ( p = .01) and on Day 7 ( p = .03). Conclusion: Our results linking CLD and higher oxygen requirements with low oxidative stress contradict previous reports. Findings identify a gap in knowledge for postresuscitation oxygen therapy in preterm infants and expose the role of oxidative stress from inflammation and intermittent hypoxia in the etiology of CLD.

Palliative care providers have for a long time recognized that there are seriously ill or terminal patients who progress beyond the experiences of psychological trauma, coping, and acceptance.

e24170 Background: Cancer-related cognitive impairment (CRCI) affects 45% of colorectal cancer (CRC) patients prior to treatment. This study aimed to explore the neural mechanisms of CRCI in this severely understudied population by using a combination of neuropsychological and cognitive neurophysiology assessments. Methods: Newly diagnosed Stage I-IV CRC patients were recruited at a Midwestern tertiary medical center. Enrollment criteria included normal or corrected to normal vision and no prior cancer within 3 years. Healthy comparisons were recruited and demographically-matched to Stage III/IV patients scheduled to receive chemotherapy. Participants completed neuropsychological measures of processing speed, psychomotor speed, executive function, and verbal memory at study baseline. We recorded scalp electroencephalography while participants performed a computer-based cognitive task designed to measure control over spatial attention. Two event-related potentials were measured following presentation of a task-irrelevant spatial cue: (1) N2, a neural correlate of stimulus selection emerging approximately 160 milliseconds after stimulus presentation; and (2) N2pc, a neural correlate of spatial attention allocation emerging approximately 200 milliseconds after stimulus presentation. Results: CRC patients were enrolled within 4-8 weeks following surgery for Stage I (11%), II (31%), and III (35%) CRC; Stage IV patients (23%) started chemotherapy without surgery. Patients (n = 26) and controls (n = 14) were matched on age and gender; patients were trending toward lower education than controls (p = .06). Patients performed worse than controls on executive function assessments (Trials B: p = .049; Stroop: p = .025). N2 amplitudes were smaller in patients than controls (p = 0.032. N2pc amplitudes were larger in patients than controls (p = .092). N2 amplitudes were associated with Stroop interference scores (r = 0.50, p = .068). Conclusions: CRC patients demonstrated impaired executive function performance at baseline. Neurophysiological data suggest impairments may emerge from limited neural resources available for stimulus selection and poor control over spatial attention. Correlations between neurophysiological data and executive function performance suggest participants better able to overcome task-irrelevant interference had relatively more neural resources available for stimulus selection. Overall, these results suggest patients may be limited in their ability to focus their attention on caregiver and health care team instructions. Clinical trial information: NCT03683004 .

Introduction: Geriatric assessment can predict the risk of toxicities of chemotherapy in older adults. Genetic risk categories correlate with survival following intensive chemotherapy in AML. Integrating geriatric assessment for patient profiling and genetic profiling of leukemic cells represents an innovative precision medicine approach to personalize therapy selection in older adults with AML. We report results of a pre-planned interim analysis of a pragmatic phase II trial using such strategy that has an overarching goal to reduce early mortality (NCT03226418). Methods: Patients ≥60 years with a new diagnosis of AML underwent geriatric assessment prior to initiation of treatment. Geriatric assessment of physical function, cognitive function and comorbidity burden were used to determine fitness for intensive chemotherapy (Table 1). Additional assessment included Karnofsky Performance Scale (KPS), Patient Health Questionnaire-9 (PHQ-9), and Mini Nutritional Assessment-Short Form (MNA). Genetic profiling for therapy selection relied on karyotyping and followed the 2017 European LeukemiaNet criteria. While available mutation test results were incorporated to risk stratify, the study did not require to wait for the results prior to therapy initiation given an anticipated turnaround time of 1-2 weeks for mutation test results. Therapy selection followed the algorithm demonstrated in Figure 1. Patients with good or intermediate-risk AML received intensive chemotherapy such as 7+3 +/- gemtuzumab or midostaurin if determined to be fit. Patients with high-risk AML received low-intensity chemotherapy such as a hypomethylating agent with or without novel drugs, or CPX 351 if they were fit and met the FDA-approved indications. Patients with organ dysfunction (e.g. creatinine ≥2 mg/dl) and those requiring chemotherapy for other malignancy received low-intensity chemotherapy. Chemotherapy at diagnosis or follow up could be administered in community oncology settings. Patients were followed for assessment of quality of life, functional and oncologic outcomes. Results: Between July 2017-June 2019, a total of 31 patients (including 1 MDS patient considered screen failure) were enrolled. The pre-planned interim analysis results are based on the first 27 AML patients. Baseline characteristics included a median age of 70 years (range 60-84 years), 56% female, 96% white, and a median KPS of 80% (range 60-100%). As presented in Table 1, over half of the patients had ≥3 comorbidities, impairment in objective physical function (short physical performance battery) and Montreal Cognitive Assessment. Additionally, 67% had poor nutritional status (MNA score of ≤11) and 26% had abnormal depression screen (PHQ-9 score of ≥10). Risk categories included adverse (64%), intermediate (16%), and good-risk AML (20%). Patients had one or more of the following mutations: FLT3 ITD (11%), NPM1 (22%), biallelic CEBPA (4%), IDH1 (15%), IDH2 (8%), RUNX1 (15%), ASXL1 (22%), and TP53 (19%). Three patients received intensive chemotherapy; CPX 351 (n=2) or 7+3+ gemtuzumab (n=1). Other patients received decitabine or azacitidine alone (n=16), azacitidine and venetoclax (n=5) or decitabine and midostaurin (n=3). The median time from diagnosis to therapy initiation was 7 days (0-20 days) whereas the median time from enrollment to therapy initiation was 2 days (range 0-9). Mortality at 30 days from diagnosis was 3.7% (95% confidence interval, CI 0.7-18.3%) and at 90 days was 29.6% (95% CI 15.9-48.5%). Mortality compared favorably to an unmatched historical cohort of patients ≥60 years treated at our center between 2011-2016, where 30-day mortality was 30% (95% CI 22-40%) and 90-day was 41% (95% CI 32-52%) (Future Oncol. 2019;15:1989-95). Conclusions: Our model to personalize AML therapy selection represents an innovative approach to precision medicine that incorporates both geriatric assessment for patient profiling and genetic profiling of leukemia cells. Geriatric assessment demonstrated high frequency of impairment in objective physical and cognitive function. Patients were able to start therapy within a median of 2 days following enrollment. Pragmatic aspects of the trial included broad eligibility criteria and co-management of patients with community oncologists. Our pre-planned interim analysis data appear promising with lower rates of early mortality compared to unmatched historical controls. Disclosures Bhatt: Pfizer: Consultancy; CSL Behring: Consultancy; Agios: Consultancy; Abbvie: Consultancy; Partner therapeutics: Consultancy; Incyte: Consultancy, Research Funding; Tolero Pharmaceuticals: Research Funding; National Marrow Donor Program: Consultancy. Al-Kadhimi:Celldex Biotech: Other: Stocks; Seattle Genetics: Other: Stocks. Armitage:Oncology Analytics: Consultancy; Partner Therapeutics: Consultancy; Samus Therapeutics: Consultancy; Ascentage: Consultancy; Tesaro bio: Membership on an entity's Board of Directors or advisory committees; Union Pacific: Consultancy. Holstein:GSK: Consultancy; Genentech: Membership on an entity's Board of Directors or advisory committees; Sorrento: Consultancy; Celgene: Consultancy; Takeda: Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees. Gundabolu:Samus Therapeutics: Research Funding; Jazz pharmaceuticals: Consultancy; Pfizer: Consultancy; Novartis: Consultancy. OffLabel Disclosure: Single agent azacitidine and decitabine as well as decitabine in combination with midostaurin are not approved by the US FDA for acute myeloid leukemia.

Among patients who survive over two years post-allo-HSCT, cGVHD and subsequent cancers represent a significant source of morbidity and mortality. Long-term treatment with immunosuppressive agents and cGVHD-related immune dysregulation may promote the development of subsequent cancers. The burden of subsequent cancers has not yet been described in patients with the most severe manifestations of cGVHD, who likely represent a high-risk population. 439 patients were enrolled on the prospective NIH Chronic GVHD Natural History Study from 2004 to 2019, underwent one-week evaluation by subspecialists, and were scored in accordance with 2005 NIH criteria. Follow-up data were collected by annual survey in which patients self-reported cancer diagnoses and provided consent for confirmatory medical records. Cumulative incidence was estimated for non-melanoma skin cancer (NMSC) competing with death, relapse, or cancer other than NMSC and for cancer other than NMSC competing with death or relapse using the method of Gooley. Potential predictors of subsequent cancers including demographics, transplant characteristics, and cGVHD-related factors were assessed using Gray's test in univariable analysis and Cox proportional hazards models in multivariable analysis. Patients must have been free of post-transplant relapse, NMSC (for NMSC analyses only), and cancer other than NMSC at evaluation to be included in analysis. 22 NMSC and 19 cancers other than NMSC were observed among 205 eligible patients, with cumulative incidences at 60 months of 11.2% (95% CI: 6.9-16.7) and 7.3% (95% CI 4.1-11.8), respectively. The most common cancers other than NMSC were oral squamous cell carcinoma and melanoma (n=6 each). Factors associated with NMSC in univariable analysis were older age at transplant, older age at evaluation, having received sirolimus for cGVHD, having received extracorporeal photopheresis or psoralen-ultraviolet therapy for cGVHD as well as higher CRP, higher NK cell count, and greater BMI at evaluation. Only older age at transplant (HR=2.12; 95% CI: 1.35-3.31) and higher CRP (HR=9.61; 95% CI: 1.29-71.73) remained associated in the multivariable model. Factors associated with subsequent cancers other than NMSC in univariable analysis were T-cell depletion, lymphoid malignant indication for transplant, and increasing severity of oral cGVHD by NIH score. Only lymphoid malignant indication for transplant (HR=2.58; 95% CI: 1.31-5.07) remained significant in multivariable analysis. The association of CRP with NMSC may represent an effect of cGVHD-related inflammation, with CRP previously associated with cGVHD severity. Interestingly, sirolimus was associated with increased risk of NMSC despite its purported antineoplastic effects. One study has previously reported increased risk of NMSC in allo-HSCT recipients treated with sirolimus, however, numerous studies have reported that sirolimus reduces risk of NMSC in solid organ recipients. In this study population, sirolimus was often prescribed later in patients already with refractory cGVHD and adjustment for measures of disease severity attenuated this association in multivariable modeling. The association of lymphoid indication with cancers other than NMSC may be attributable to age as patients with lymphoid malignancies were older at transplant than those with other indications. Additionally, differences in pre-transplant therapies for lymphoid vs. other indications may also contribute to this observation. Post-transplant patients with cGVHD are at high risk of developing subsequent cancers, with higher incidence of NMSC than other cancers. This study identifies potential risk groups for subsequent cancers, highlights patients who may benefit from increased surveillance, and reiterates the need for effective cGVHD therapy to mitigate risks associated with long-term immunosuppression and immune dysfunction. Disclosures Cowen: UpToDate: Other: Royalties; Elsevier: Other: Royalties.

Introduction: Whether adults aged ≥60 years with AML benefit from multiagent (or intensive) chemotherapy is a matter of controversy. Prior studies have demonstrated conflicting results. We performed analysis of a large National Cancer Data Base (NCDB) to determine the value of multiagent vs. single agent chemotherapy. Methods: NCDB captures approximately 70% of all cancer diagnoses in US, and undergoes rigorous quality monitoring. We utilized NCDB to identify patients aged 60-79 years, who were newly diagnosed with AML (other than APL) between the years 2004-2014. Logistic regression model was used to determine factors associated with the use of multiagent chemotherapy. Kaplan-Meier curves were generated and compared using the log rank test. Logistic regression model and Cox Proportional Hazard model were used for one-month mortality and OS analyses, respectively. In a separate analysis, patients who received single agent (n=6743) vs. multiagent chemotherapy (n=6743) were matched based on the variables age, Charlson comorbidity score, and AML subtypes (good-risk AML, therapy-related AML/AML with myelodysplasia related changes, and other intermediate/high-risk AML). A Cox Proportional Hazard model was used for OS analysis of the matched cohort. Results: Of a total of 25,621 patients, 70% received multiagent chemotherapy. The receipt of multiagent chemotherapy declined with increasing age, Charlson comorbidity score, AML subtypes other than good-risk, female, non-academic center, shorter distance traveled to receive care, lower rate of high school graduation, and more recent year of diagnosis. Patients treated with multiagent chemotherapy had higher likelihood of receiving hematopoietic cell transplant (HCT) (9% vs. 1%); lower one-month mortality (11% vs. 19%); and greater 1-year OS (43% vs. 28%) (Figure 1). The use of multiagent chemotherapy had particularly higher 1-year OS in patients aged 60-64 and 65-69 years, in good-risk AML, patients with Charlson comorbidity score of 0-1 and those who did not receive upfront HCT consolidation (Table 1). One-month mortality (odds ratio 1.64, 95% confidence interval, CI 1.51-1.78) and OS (hazard ratio, HR 1.32, 95% CI 1.28-1.36) remained more favorable for multiagent chemotherapy group in multivariable analyses. Other factors that affected OS included age, comorbidity, AML subtypes, median household income, insurance, use of HCT, academic status of facility, distance traveled to receive care, sex and year of diagnosis. In a matched analysis of 13,486 patients, the use of single agent vs. multiagent chemotherapy resulted in a higher risk of mortality (HR 1.28, 95% CI 1.23-1.32). Conclusions: In one of the largest real-world studies, we demonstrate an association between factors such as age, comorbidity and AML subtypes and the use of multiagent chemotherapy. After adjusting for covariates, the use of multiagent chemotherapy among older adults was associated with higher receipt of HCT, and improved one-month mortality and OS. Improved OS was confirmed in a matched analysis. Certain groups such as patients younger than 70 years, good-risk AML and those with low Charlson comorbidity score had the greater OS benefit with the use of multiagent chemotherapy. Further studies to determine the role of multiagent or intensive chemotherapy are particularly important with approvals of several new drugs in the recent years and integration of many novel drugs in both low-intensity and intensive chemotherapy regimens. Disclosures Bhatt: Tolero Pharmaceuticals: Research Funding; Incyte: Consultancy, Research Funding; Partner therapeutics: Consultancy; Abbvie: Consultancy; Agios: Consultancy; CSL Behring: Consultancy; National Marrow Donor Program: Consultancy; Pfizer: Consultancy. Holstein:Celgene: Consultancy; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy; Genentech: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Sorrento: Consultancy. Al-Kadhimi:Celldex Biotech: Other: Stocks; Seattle Genetics: Other: Stocks. Armitage:Union Pacific: Consultancy; Tesaro bio: Membership on an entity's Board of Directors or advisory committees; Ascentage: Consultancy; Samus Therapeutics: Consultancy; Oncology Analytics: Consultancy; Partner Therapeutics: Consultancy. Gundabolu:Pfizer: Consultancy; Novartis: Consultancy; Jazz pharmaceuticals: Consultancy; Samus Therapeutics: Research Funding.

Impaired episodic memory in older adults has been linked to many factors. One of these factors is sleep disturbances, which are reported by more than 50% of older adults. The relationship between episodic memory and sleep disturbances remains unclear, however, because of the multiple types of measures of sleep and episodic memory used in previous studies. The purpose of this integrative literature review was to integrate and compare findings on this relationship in adults aged 65 years. An electronic search was conducted in PubMed, Cumulative Index to Nursing and Allied Health Literature, PsychINFO, and Medline for material published from the inception of the databases to December 2016. The literature search produced 13 data-based, peer-reviewed, and primary research articles that met eligibility criteria. The synthesized results from these articles provide evidence that older adults with 6–8 hr of self-reported total sleep time had better episodic memory than older adults with ≤5 hr or ≥9 hr of total sleep time. Shorter length and lower percentage of slow-wave sleep were associated with reduced episodic memory in older adults, but the results were controversial. Selection of different measurements and inconsistent variables across studies increased the difficulty of synthesizing and comparing the results. The diversity of covariates controlled in the included articles raise questions regarding which covariates should be controlled in such studies of sleep and episodic memory in older adults. The numerous study limitations were thus major barriers to understanding the relationship between sleep disturbances and episodic memory.

SIGNIFICANCE: Poor sleep quality is a common and persistent problem reported by women with breast cancer (BC). Empirical evidence identifies many risk factors for self-reported sleep deficiency but inconsistencies limit translation to practice. PURPOSE: To increase understanding of risk factors predicting self-reported poor sleep quality in women with BC who completed the Breast Cancer Collaborative Registry (BCCR) questionnaire. METHODS: This cross-sectional study recruited women with a first diagnosis of BC (n=1302) at five sites in Nebraska and South Dakota. Women completed the BCCR that includes numerous variables as well as the Pittsburgh Sleep Quality Index (PSQI) and SF-36v2 (n=1260). Descriptive statistics and non-parametric correlations were used to determine associations and create predictive models of sleep quality with BCCR variables and SF36v2 subscales. RESULTS: Most women were white (93.7%) and married (71.5%); mean age was 60.1 (21–90) years. Poor sleep was self-reported by 53% of women. Seven variables were highly associated with sleep quality (p≤0.001). The first model found younger age, lower physical activity, and higher fatigue were the strongest combined and independent variables predicting poor sleep quality (F=23.0 (p

In 2005, the National Institutes of Health (NIH) chronic graft-versus-host disease (cGVHD) consensus project provided diagnosis and staging criteria, based mostly on clinical experience and expert opinion. These criteria were revised in 2014, aiming to provide enhanced specificity and clarity. However, the impact of 2014 changes to the original NIH cGVHD severity scoring criteria has not been reported. In this study, 284 patients, prospectively enrolled on the National Cancer Institute's cross-sectional cGVHD natural history study, were scored using the 2005 NIH cGVHD criteria and then rescored according to the 2014 modifications. In comparing the two criteria, 2014 cGVHD global severity scoring resulted in a tendency toward being categorized as milder scores (75 vs. 72% of severe score per 2014, p = 0.0009), with a statistically significant shift in NIH liver and lung scores toward milder categories (p

Sleep disturbances are reported in up to 60% of patients with cancers of many types and stages. Impaired sleep has an array of detrimental effects on the health of individuals with cancer and their family caregivers, with significant societal costs. Cancer-related sleep disturbances can also affect health-related quality of life by way of persistent fatigue and altered mood. Chronic sleep loss may lead to poor adherence to cancer treatments and higher morbidity and mortality. Sleep disturbances can range from perceived or actual alterations in usual sleep patterns to diagnosed sleep disorders meeting precise diagnostic criteria. New onset or worsening of sleep disturbances are common and disabling problems for those with cancer before treatment, during treatments such as chemotherapy and radiation therapy, and after completion of treatments. Cancer pathology, treatments, and symptoms such as pain and hot flashes, disruption of daily activity and circadian rhythms, and unhealthy sleep habits contribute to acute and chronic sleep disturbances. In this chapter, we describe the prevalence of common sleep problems in adults with cancer and define key terms. This chapter also provides information about biological and behavioral conceptual models of sleep and guidelines for the assessment and management of sleep disturbances. Emphasis is given to the latest non-pharmacological evidence-based treatments. We discuss the importance of provider awareness of sleep problems and patient education. Finally, we identify barriers to behavioral change and strategies to assist the cancer patient and family to self-manage sleep problems.

Usporedba NIH kriterija za kronični GVHD 2005 i 2014 godina.

Study objectives Obstructive Sleep Apnea (OSA) contributes to all-cause mortality. An American Academy of Sleep Medicine task force is focusing on improving detection and categorization of OSA symptoms and severity to promote screening, assessment, and diagnosis. The purpose of this study was to psychometrically compare measures used in OSA screening (Berlin, Epworth Sleepiness Scale (ESS), STOP Bang) and a portable sleep monitor (PSM) to apnea-hypopnea index (AHI) and levels from polysomnogram (PSG). Methods An observational, cross-sectional design was used. Patients referred to a sleep specialist were enrolled at initial sleep evaluation. Participants completed measures used in OSA screening, then sent home for one night using PSM. PSGs were ordered by the physician and AHI results were obtained from the medical record. Results Participants (N = 170) were enrolled in the study. Almost all participants completed the OSA measures, approximately half-completed PSM measurement, and the majority completed laboratory PSG. The STOP Bang had the highest levels of sensitivity; the ESS had the lowest. The ESS had the highest specificity and reliability levels; the STOP Bang had the lowest. The PSM measure had the highest positive predictive value (PPV) and the strongest psychometric properties of the screening measures. Conclusions The STOP Bang was the preferred self-report OSA screening measure because of high levels of sensitivity. The ESS was the least desirable measure. PSM measurement consistently predicted the presence of OSA but at the expense of low sensitivity at AHI levels ≥30. This expands the knowledge of validity testing of screening measures used for OSA.

Answer questions and earn CME/CNE Evidence regarding cancer-related fatigue (fatigue) has accumulated sufficiently such that recommendations for screening, evaluation, and/or management have been released recently by 4 leading cancer organizations. These evidence-based fatigue recommendations are available for clinicians, and some have patient versions; but barriers at the patient, clinician, and system levels hinder dissemination and implementation into practice. The underlying biologic mechanisms for this debilitating symptom have not been elucidated completely, hindering the development of mechanistically driven interventions. However, significant progress has been made toward methods for screening and comprehensively evaluating fatigue and other common symptoms using reliable and valid self-report measures. Limited data exist to support the use of any pharmacologic agent; however, several nonpharmacologic interventions have been shown to be effective in reducing fatigue in adults. Never before have evidence-based recommendations for fatigue management been disseminated by 4 premier cancer organizations (the National Comprehensive Cancer, the Oncology Nursing Society, the Canadian Partnership Against Cancer/Canadian Association of Psychosocial Oncology, and the American Society of Clinical Oncology). Clinicians may ask: Are we ready for implementation into practice? The reply: A variety of approaches to screening, evaluation, and management are ready for implementation. To reduce fatigue severity and distress and its impact on functioning, intensified collaborations and close partnerships between clinicians and researchers are needed, with an emphasis on system-wide efforts to disseminate and implement these evidence-based recommendations.

Home sleep apnea testing (HSAT) has increased due to improvements in technology, accessibility, and changes in third party reimbursement requirements. Research studies using HSAT have not consistently reported procedures and methodological challenges. This paper had two objectives: (1) summarize the literature on use of HSAT in research of adults and (2) identify methodological strategies to use in research and practice to standardize HSAT procedures and information. Search strategy included studies of participants undergoing sleep testing for OSA using HSAT. MEDLINE via PubMed, CINAHL, and Embase with the following search terms: “polysomnography,” “home,” “level III,” “obstructive sleep apnea,” and “out of center testing.” Research articles that met inclusion criteria (n = 34) inconsistently reported methods and methodological challenges in terms of: (a) participant sampling; (b) instrumentation issues; (c) clinical variables; (d) data processing; and (e) patient acceptability. Ten methodological strategies were identified for adoption when using HSAT in research and practice. Future studies need to address the methodological challenges summarized in this paper as well as identify and report consistent HSAT procedures and information.

There is renewed interest in identifying breast cancer patients' participation in decision-making about adjuvant chemotherapy. There is a gap in the literature regarding the impact of these decisions on quality of life (QOL) and quality of care (QOC). Our aims were to determine similarities and differences in how patients diagnosed with breast cancer preferred to make decisions with providers about cancer treatment, to examine the patient's recall of her role when the decision was made about chemotherapy and to determine how preferred and actual roles, as well as congruence between them, relate to QOL and perceived QOC.Greater Plains Collaborative clinical data research network of PCORnet conducted the 'Share Thoughts on Breast Cancer' survey among women 12-18 months post-diagnosis at eight sites in seven Midwestern United States. Patients recalled their preferred and actual treatment decision-making roles and three new shared decision-making (SDM) variables were created. Patients completed QOL and QOC measurements. Correlations and t-tests were used.Of 1235 returned surveys, 873 (full sample) and 329 (subsample who received chemotherapy) were used. About one-half of women in both the full (50.7%) and subsample (49.8%,) preferred SDM with providers about treatment decisions, but only 41.2% (full) and 42.6% (subsample) reported experiencing SDM. Significant differences were found between preferred versus actual roles in the full (p .001) and subsample (p .004). In the full sample, there were no relationships between five decision-making variables with QOL, but there was an association with QOC. The subsample's decision-making variables related to several QOL scales and QOC items, with a more patient-centered decision than originally preferred related to higher physical and social/family well-being, overall QOL and QOC.Patients benefit from providers' efforts to identify patient preferences, encourage an active role in SDM, and tailor decision making to their desired choice.

Importance Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. Objective The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM’s working group in colorectal cancer. Evidence Review The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). Findings After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. Conclusions A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.

An overview of proceedings, findings, and recommendations from the workshop on "Advancing Symptom Science Through Symptom Cluster Research" sponsored by the National Institute of Nursing Research (NINR) and the Office of Rare Diseases Research, National Center for Advancing Translational Sciences, is presented. This workshop engaged an expert panel in an evidenced-based discussion regarding the state of the science of symptom clusters in chronic conditions including cancer and other rare diseases. An interdisciplinary working group from the extramural research community representing nursing, medicine, oncology, psychology, and bioinformatics was convened at the National Institutes of Health. Based on expertise, members were divided into teams to address key areas: defining characteristics of symptom clusters, priority symptom clusters and underlying mechanisms, measurement issues, targeted interventions, and new analytic strategies. For each area, the evidence was synthesized, limitations and gaps identified, and recommendations for future research delineated. The majority of findings in each area were from studies of oncology patients. However, increasing evidence suggests that symptom clusters occur in patients with other chronic conditions (eg, pulmonary, cardiac, and end-stage renal disease). Nonetheless, symptom cluster research is extremely limited and scientists are just beginning to understand how to investigate symptom clusters by developing frameworks and new methods and approaches. With a focus on personalized care, an understanding of individual susceptibility to symptoms and whether a "driving" symptom exists that triggers other symptoms in the cluster is needed. Also, research aimed at identifying the mechanisms that underlie symptom clusters is essential to developing targeted interventions.

Potentially inappropriate medication (PIM) use is a significant worldwide public health problem. Community-dwelling older adults are susceptible to the negative outcomes associated with the use of PIMs. A database search (January 1991–June 2013) produced 19 prospective correlational and 10 intervention studies. The current state of the science reveals that conceptual clarity is lacking regarding the use of PIMs. The prevalence of PIM use is well documented in an abundance of descriptive studies. However, researchers have not examined an intervention’s effects on health outcomes in community-dwelling older adults. Although independent older adults can acquire PIMs outside of a provider, current interventions aim to change the behavior of the prescribing physician and pharmacist. Nurses need to collaborate with other disciplines in PIM use research. Priority needs are to design interventions that reduce the use of PIMs and negative health outcomes. [Res Gerontol Nurs. 2014; 7(4):178–192.]

Purpose/objectives To examine the effect of cognitive-behavioral therapy for insomnia (CBTI) on sleep improvement, daytime symptoms, and quality of life (QOL) in breast cancer survivors (BCSs) after cancer treatment. Design A prospective, longitudinal, randomized, controlled trial. Setting Oncology clinics, breast cancer support groups, and communities in Colorado. Sample 56 middle-aged BCSs with chronic insomnia. Methods Women were randomly assigned to CBTI or behavioral placebo treatment (BPT) and completed measures of sleep, QOL, functioning, fatigue, and mood at baseline, postintervention, and at three- and six-month follow-ups. Main research variables Sleep outcomes (e.g., sleep efficiency, sleep latency, total sleep time, wake after sleep onset, number of nightly awakenings); secondary variables included sleep medication use, insomnia severity, QOL, physical function, cognitive function, fatigue, depression, anxiety, and sleep attitudes or knowledge. Findings Sleep efficiency and latency improved more in the CBTI group than the BPT group; this difference was maintained during follow-up. Women in the CBTI group had less subjective insomnia, greater improvements in physical and cognitive functioning, positive sleep attitudes, and increased sleep hygiene knowledge. No group differences in improvement were noted relative to QOL, fatigue, or mood. Conclusions Nurse-delivered CBTI appears to be beneficial for BCSs' sleep latency/efficiency, insomnia severity, functioning, sleep knowledge, and attitudes more than active placebo, with sustained benefit over time. Implications for nursing Oncology nurses are in a unique position to identify insomnia in cancer survivors. When sleep disturbances become chronic, nurses need to make recommendations and referrals.

Chronic graft-versus-host disease (cGVHD) reduces relapse risk in patients with hematological malignancies treated with allogeneic hematopoietic stem cell transplant (allo-HSCT). Nevertheless, relapse remains a major barrier to treatment success. Better understanding of factors determining relapse risk in the cGVHD patient population may lead to development of improved strategies for malignancy control. We hypothesized that cGVHD-related factors would contribute to decreased risk of relapse in addition to other well-known transplant related factors. Patients (N=275) were enrolled on the NCI cross-sectional cGVHD natural history study (NCT00092235) and described using NIH criteria for disease severity and organ scoring. Subjects were subsequently followed for malignancy relapse and survival. Potential predictors of relapse were assessed for their association with risk of relapse using Gray's test. Cox proportional hazards modeling was performed to estimate the joint effect of factors on risk of relapse. Seventeen patients experienced relapse at a median follow-up of 85 months. 48-month cumulative incidence of relapse was 5.7% (95% CI 3.3-8.9%). Median progression-free survival was 156 months. Factors associated with increased risk of relapse in multivariable analysis included aggressive malignancy as an indication for transplant (HR 3.93, 95% CI 1.27-9.10), shorter time from transplant to cGVHD evaluation (HR 0.24, 95% CI 0.06-0.88), and higher number of prior lines of systemic immunosuppressive therapy for cGVHD (HR 0.34, 95% CI 0.12-0.98). Interestingly, conditioning intensity, T-cell depletion, HLA-match, female donor to male recipient, blood vs. marrow stem cell source, or malignancy remission status at transplant were not predictive of relapse in univariate or multivariate analyses. These data suggest an important inverse relationship between cGVHD severity and likelihood of relapse post-transplant. Most classical relapse predictors seem to be abrogated by these effects.