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Context: Spiritual, existential, and psychological issues represent central components of quality of life (QOL) in palliative care. A better understanding of the dynamic nature underlying these components is essential for the development of interventions tailored to the palliative context.Objectives: The aims were to explore 1) the relationship between spirituality, meaning in life, wishes for hastened death and psychological distress in palliative patients and 2) the extent to which these nonphysical determinants influence QOL.Methods: A cross-sectional study involving face-to-face interviews with Swiss palliative patients was performed, including the Schedule for Meaning in Life Evaluation (SMILE), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), the Idler Index of Religiosity (IIR), the Hospital Anxiety and Depression Scale (HADS), and the Schedule of Attitudes toward Hastened Death (SAHD). QOL was measured with a single-item visual analogue scale (0-10).Results: Two hundred and six patients completed the protocol (51.5% female; mean age = 67.5 years). The results indicated a significant negative relationship between FACIT-Sp/SMILE and HADS total scores (P = 0.000). The best model for QOL explained 32.8% of the variance (P = 0.000) and included the FACIT-Sp, SMILE, and SAHD total scores, the IIR "private religiosity" score, as well as the HADS "depression" score.Conclusion: Both spiritual well-being and meaning in life appear to be potential protective factors against psychological distress at the end of life. Since nonphysical determinants play a major role in shaping QOL at the end of life, there is a need for the development of meaning-oriented and spiritual care interventions tailored to the fragility of palliative patients. [ABSTRACT FROM AUTHOR]

The combined approach of incubating environmental samples with stable isotope-labeled substrates followed by single-cell analyses through high-resolution secondary ion mass spectrometry (NanoSIMS) or Raman microspectroscopy provides insights into the in situ function of microorganisms. This approach has found limited application in soils presumably due to the dispersal of microbial cells in a large background of particles. We developed a pipeline for the efficient preparation of cell extracts from soils for subsequent single-cell methods by combining cell detachment with separation of cells and soil particles followed by cell concentration. The procedure was evaluated by examining its influence on cell recoveries and microbial community composition across two soils. This approach generated a cell fraction with considerably reduced soil particle load and of sufficient small size to allow single-cell analysis by NanoSIMS, as shown when detecting active N2-fixing and cellulose-responsive microorganisms via 15N2 and 13C-UL-cellulose incubations, respectively. The same procedure was also applicable for Raman microspectroscopic analyses of soil microorganisms, assessed via microcosm incubations with a 13C-labeled carbon source and deuterium oxide (D2O, a general activity marker). The described sample preparation procedure enables single-cell analysis of soil microorganisms using NanoSIMS and Raman microspectroscopy, but should also facilitate single-cell sorting and sequencing. [ABSTRACT FROM AUTHOR]

Abstract: Context: This is a subset analysis of fatigue data and associated clinical variables collected as part of the European Palliative Care Research Collaborative Computerized Symptom Assessment (CSA) study. The overall aim of CSA was to determine the prevalence of common symptoms in a mixed advanced cancer group using an electronic data collection system. Objectives: This analysis was conducted to identify factors independently associated with fatigue. Methods: Only patient records containing complete data for all three measured blood parameters in the CSA study (C-reactive protein [CRP], hemoglobin, and albumin) were included in our subset analysis (n =720). Participants with locoregional or metastatic disease of all tumor types were included (with or without concurrent palliative anticancer treatment). A large number of symptoms were recorded using a predesigned computer program and widely used symptom measurement scales. Fatigue was measured using a well-validated three-item fatigue scale taken from the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. A logistic regression model was developed using a cutoff score based on the available normative data to define the presence or the absence of severe fatigue. Results: Cases of fatigue were independently associated with chemotherapy treatment and experiencing other symptoms such as pain and depression. There was a moderate association with hemoglobin level. However, there was no link to cachexia, albumin, or CRP. Conclusion: Severe fatigue is linked with treatment history and hemoglobin levels rather than CRP, mood, and other common symptoms in a mixed advanced cancer group. [Copyright &y& Elsevier]

Abstract: Context: Autonomic nervous system dysfunction (AD) is a common syndrome in patients with advanced cancer. It is associated with decreased survival in several patient populations, including diabetes mellitus, heart failure, and neurological diseases. Based on this evidence, we hypothesized that autonomic dysfunction is associated with decreased survival in patients with advanced cancer. Objectives: The objective of this preliminary study was to test the association between AD, as measured by the standardized Ewing test and heart rate variability (HRV) measures, and survival in this patient population. Methods: We examined the relationship between survival and parameters of AD in subjects who participated in a prospective study of autonomic dysfunction and hypogonadism in male patients with advanced cancer. Eligibility criteria were defined based on the prospective study protocol. We collected demographic information, date of death (obtained from the online Social Security Death Index database), date of study entry, and Ewing and HRV scores. We defined survival as the interval between study entry and date of death. A survival analysis was used to test the association between survival (in days) and Ewing test (0–5) and measures of HRV, including time domain (standard deviation of normal to normal beat interval [SDNN]) and frequency domain (ultra low, very low, low, and high). Four patients were still alive at the time of this study and included in the survival analysis as being censored. Results: Forty-seven male patients were included in this study. Median age was 59 years (range: 20–79), and 30 out of 47 (63%) were Caucasians. AD, defined as Ewing score greater than 2, was present in 38 out of 47 (80%) of the patients. Median Ewing score was 3 (1–5), indicating moderate to severe AD. Spearman correlation for Ewing score and SDNN was 0.44 (P = 0.002). There was a significant association between abnormal Ewing score and survival (P < 0.0001) and abnormal SDNN HRV and survival (P = 0.056). Conclusion: AD is associated with shorter survival in male patients with advanced cancer. Further longitudinal research in a large cohort is justified based on. [Copyright &y& Elsevier]

Abstract: To assess cancer-related fatigue (CRF), multidimensional questionnaires are required. The aim of this study was to evaluate single-item fatigue (SIF) screening questions—one for global fatigue and three for the fatigue domains (cognitive, emotional, and physical)—for their immediate use in daily oncology practice. Sixty-one fatigued patients with advanced cancer completed SIF assessments (visual analog scales for global fatigue and for fatigue in the cognitive, emotional, and physical domains, respectively), and the Brief Fatigue Inventory (BFI), the Fatigue Assessment Questionnaire (FAQ), the Hospital Anxiety and Depression Scale (HADS), and the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-C30 (QLQ-C30). SIF-global correlated with BFI (r =0.51), and the domain-SIFs correlated with their respective FAQ domains (cognitive r =0.59; affective r =0.45; physical r =0.33) and functional EORTC QLQ-C30 subscales (r =0.62; r =0.42; r =0.34). The SIF-emotional also correlated with HADS-Anxiety (r =0.43) and HADS-Depression (r =0.62). Principal component analysis (domain-SIF; respective FAQ and functional EORTC QLQ-C30 subscales) revealed three clusters and a two-factor model (cognitive/emotional, physical), explaining 74% of variability. Patients with one predominant SIF domain had more domain-tailored fatigue interventions than had patients with mixed SIFs. These data suggest that three simple SIF questions permit rapid assessment of the physical and cognitive and probably the emotional domains of CRF in patients with advanced cancer. [Copyright &y& Elsevier]

Abstract: The purpose of this study was to determine the impact of physician sitting versus standing on the patient''s preference of physician communication style, and perception of compassion and consult duration. Sixty-nine patients were randomized to watch one of two videos in which the physician was standing and then sitting (video A) or sitting and then standing (video B) during an inpatient consultation. Both video sequences lasted 9.5 minutes. Thirty-five patients (51%) blindly preferred the sitting physician, 16 (23%) preferred the standing, and 18 (26%) had no preference. Patients perceived that their preferred physician was more compassionate and spent more time with the patient when compared with the other physician. There was a strong period effect favoring the second sequence within the video. The patients blinded choice of preference (P =0.003), perception of compassion (P =0.0016), and other attributes favored the second sequence seen in the video. The significant period effect suggests that patients prefer the second option presented, notwithstanding a stated preference for a sitting posture (55/68, 81%). Physicians should ask patients for their preference regarding physician sitting or standing as a way to enhance communication. [Copyright &y& Elsevier]

To characterize a new, one-stop multidisciplinary palliative care (MD) clinic which offers standardized multidisciplinary assessment, specific care recommendations, patient and family education, and on-site counseling, we retrospectively compared the assessments of 138 consecutive patients with advanced cancer referred to the MD clinic and 77 patients referred to a traditional pain and symptom management (PSM) clinic. The two groups were similar in tumor type, demographics, and symptom distress. The MD clinic team (physicians; nurses; pharmacists; physical, speech, and occupational therapists; social workers; chaplains; nutritionists; psychiatric nurse practitioner) delivered 1,066 non-physician recommendations (median 4 per patient, range 0–37). The PSM clinic team made no non-physician recommendations, but referred 14 patients to other medical specialists. In 80 (58%) MD-clinic patients with follow-up 9 days (median) after assessment, significant improvement was observed in pain, nausea, depression, anxiety, sleep, dyspnea, and well-being, but not in fatigue, anorexia, or drowsiness. In 83 patients interviewed after the MD clinic, satisfaction was rated as excellent (5 out of 5) in 86–97% of seven areas. Assessment at an MD clinic results in a high number of patient care recommendations, improved symptoms, and high levels of patient satisfaction. [Copyright &y& Elsevier]

Opioid-induced sedation is a major complication in patients with cancer pain. This study assessed the effectiveness of donepezil in opioid-induced sedation and related symptoms in patients with cancer pain. Twenty-seven patients who were receiving strong opioids for pain and reported sedation were enrolled. Donepezil 5 mg was given every morning for 7 days. Changes between baseline and Day 7 in sedation, pain, fatigue and other symptoms were evaluated using the Edmonton Symptom Assessment Scale. Fatigue was also measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Overall usefulness of donepezil was measured by the patient at the end of the study. In 20 evaluable patients, sedation, fatigue, anxiety, well-being, depression, anorexia and problems with sleep were significantly improved. Side effects included nausea, vomiting, diarrhea, muscle and abdominal cramps, and anorexia. Overall, however, the treatment was well tolerated. Donepezil appears to improve sedation and fatigue in patients receiving opioids for cancer pain. Randomized controlled trials of this agent are justified. [Copyright &y& Elsevier]

Presents a study which sought to assess the value of serum macrophage inhibitory factor-related protein (MRP) 8/14 levels in disease progression in persons infected with the human immunodeficiency virus (HIV), while showing how these are markers of intercurrent infections. Details on the study population used in this research; Research methods used; Results of this study.

Ectomycorrhizal fungi live in close association with their host plants and form complex interactions with bacterial/archaeal communities in soil. We investigated whether abundant or rare ectomycorrhizal fungi on root-tips of young beech trees (Fagus sylvatica) shape bacterial/archaeal communities. We sequenced 16S rRNA genes and fungal internal transcribed spacer regions of individual root-tips and used ecological networks to detect the tendency of certain assemblies of fungal and bacterial/archaeal taxa to inhabit the same root-tip (i.e. modularity). Individual ectomycorrhizal root-tips hosted distinct fungal communities associated with unique bacterial/archaeal communities. The structure of the fungal-bacterial/archaeal association was determined by both, dominant and rare fungi. Integrating our data in a conceptual framework suggests that the effect of rare fungi on the bacterial/archaeal communities of ectomycorrhizal root-tips contributes to assemblages of bacteria/archaea on root-tips. This highlights the potential impact of complex fine-scale interactions between root-tip associated fungi and other soil microorganisms for the ectomycorrhizal symbiosis.The bacterial/archaeal and fungal communities inhabiting beech tree root-tips are examined by marker gene sequencing followed by ecological network analysis, highlighting complex interactions in the ectomycorrhizal symbiosis. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: A systematical literature review evaluating the effect of dietary counseling in treating weight loss and improving energy intake in patients with advanced cancer with different stages of cachexia. Principal results: Five publications were retrieved, of which three were randomized. Two out of five studies showed less weight loss with dietary counseling (+1% weight gain vs. −1.5% weight loss, p =0.03, 1.4kg vs. −2kg, p <0.05), two presented positive effect on energy intake (92% of total caloric need vs. 73%, p <0.01, 1865±317kcal vs. 1556±497kcal, ns). Conclusion: Dietary counseling can effect energy intake and body weight, however, apparent heterogeneity between studies is present. Based on these results there is not enough proof of evidence that dietary counseling given to patients with cancer is beneficial for improving weight or energy balance in the different cachexia stages. Nutrition is an essential part of cachexia treatment as it is not considered possible to increase or stabilize weight if nutritional needs are not met. [Copyright &y& Elsevier]

Cachexia is a life-threatening disorder affecting an estimated 50–80% of cancer patients. The loss of skeletal muscle mass in patients with cachexia is associated with an increased risk of anticancer treatment toxicity, surgical complications and reduced response. Despite international guidelines, the identification and management of cancer cachexia remains a significant unmet need owing in part to the lack of routine screening for malnutrition and suboptimal integration of nutrition and metabolic care into clinical oncology practice. In June 2020, Sharing Progress in Cancer Care (SPCC) convened a multidisciplinary task force of medical experts and patient advocates to examine the barriers preventing the timely recognition of cancer cachexia, and provide practical recommendations to improve clinical care. This position paper summarises the key points and highlights available resources to support the integration of structured nutrition care pathways. [ABSTRACT FROM AUTHOR]

Context Cachexia is commonly found in cancer patients and has profound consequences; yet there is only one questionnaire that examines the patient's perspective. Objective To report a rigorously developed module for patient self-reported impact of cancer cachexia. Methods Module development followed published guidelines. Patients from across the cancer cachexia trajectory were included. In Phase 1, health-related quality of life (HRQOL) issues were generated from a literature review and interviews with patients in four countries. The issues were revised based on patient and health care professional (HCP) input. In Phase 2, questionnaire items were formulated and translated into the languages required for Phase 3, the pilot phase, in which patients from eight countries scored the relevance and importance of each item, and provided qualitative feedback. Results A total of 39 patients and 12 HCPs took part in Phase 1. The literature review produced 68 HRQOL issues, with 22 new issues arising from the patient interviews. After patient and HCP input, 44 issues were formulated into questionnaire items in Phase 2. One hundred ten patients took part in Phase 3. One item was reworded, and 20 items were deleted as a consequence of patient feedback. Conclusions The QLQ-CAX24 is a cancer cachexia-specific questionnaire, comprising 24 items, for HRQOL assessment in clinical trials and practice. It contains five multi-item scales (food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline) and four single items. [ABSTRACT FROM AUTHOR]

This article synthesizes the presentations and conclusions of an international symposium on Phase 1 oncology trials, palliative care, and ethics held in 2014. The purpose of the symposium was to discuss the intersection of three independent trends that unfolded in the past decade. First, large-scale reviews of hundreds of Phase I trials have indicated there is a relatively low risk of serious harm and some prospect of clinical benefit that can be meaningful to patients. Second, changes in the design and analysis of Phase I trials, the introduction of "targeted" investigational agents that are generally less toxic, and an increase in Phase I trials that combine two or more agents in a novel way have changed the conduct of these trials and decreased fears and apprehensions about participation. Third, the field of palliative care in cancer has expanded greatly, offering symptom management to late-stage cancer patients, and demonstrated that it is not mutually exclusive with disease-targeted therapies or clinical research. Opportunities for collaboration and further research at the intersection of Phase 1 oncology trials and palliative care are highlighted. [ABSTRACT FROM AUTHOR]

Context Oncologists perform a range of pharmacological and nonpharmacological interventions to manage the symptoms of outpatients with advanced cancer. Objectives The aim of this study was to develop and test a symptom management performance checklist (SyMPeC) to review medical charts. Methods First, the content of the checklist was determined by consensus of an interprofessional team. The SyMPeC was tested using the data set of the SAKK 96/06 E-MOSAIC (Electronical Monitoring of Symptoms and Syndromes Associated with Cancer) trial, which included six consecutive visits from 247 patients. In a test data set (half of the data) of medical charts, two people extracted and quantified the definitions of the parameters (content validity). To assess the inter-rater reliability, three independent researchers used the SyMPeC on a random sample (10% of the test data set), and Fleiss's kappa was calculated. To test external validity, the interventions retrieved by the SyMPeC chart review were compared with nurse-led assessment of patient-perceived oncologists' palliative interventions. Results Five categories of symptoms were included: pain, fatigue, anorexia/nausea, dyspnea, and depression/anxiety. Interventions were categorized as symptom specific or symptom unspecific. In the test data set of 123 patients, 402 unspecific and 299 symptom-specific pharmacological interventions were detected. Nonpharmacological interventions ( n = 242) were mostly symptom unspecific. Fleiss's kappa for symptom and intervention detections was K = 0.7 and K = 0.86, respectively. In 1003 of 1167 visits (86%), there was a match between SyMPeC and nurse-led assessment. Seventy-nine percent (195 of 247) of patients had no or one mismatch. Conclusion Chart review by SyMPeC seems reliable to detect symptom management interventions by oncologists in outpatient clinics. Nonpharmacological interventions were less symptom specific. A template for documentation is needed for standardization. [ABSTRACT FROM AUTHOR]

Abstract: Context: Cancer cachexia syndrome (CCS) is often accompanied by psychosocial consequences (PSC). To alleviate PSC, a systematic assessment method is required. Currently, few assessment tools are available (e.g., Functional Assessment of Anorexia/Cachexia Therapy). There is no systematic assessment tool that captures the PSC of CCS. Objectives: To develop a pilot item bank to assess the PSC of CCS. Methods: A total of 132 questions, generated from patient answers in a previous study, were reduced to 121 items by content analysis and evaluation by multidisciplinary experts (doctor, nutritionists, and nurses). In our two-step, cross-sectional study, patients, judged by staff to have PSC of CCS, were included, and the questions were randomly allocated to the patients. Questions were evaluated for understandability and triggering emotions, and patients were asked to provide a response using a four-point Likert scale. Subsequently, problematic questions were revised, reformulated, and retested. Results: A total of 20 patients with a variety of tumor types participated. Of the 121 questions, 31 had to be reformulated after Step 1 and were retested in Step 2, after which seven were again evaluated as not being perfectly comprehensible. In Step 1, 22 questions were found to trigger emotions, but no item required remodeling. Item performance using the Likert scale revealed no consistent floor or ceiling effects. Our final pilot question bank comprised 117 questions. Conclusion: The final item bank contains questions that are understood and accepted by the patients. This item bank now needs to be developed into a measurement tool that groups items into domains and can be used in future research studies. [Copyright &y& Elsevier]

Abstract: Context: Cancer cachexia is debilitating and affects most patients with advanced cancer. Because treatment options are poor, the psychosocial effects of cancer cachexia always should be assessed and psychosocial support provided. Objectives: To review the existing evidence of psychosocial effects of cancer cachexia with the aim of identifying factors that might be modified to improve outcomes. Methods: We carried out a systematic literature search in MEDLINE and Embase. The search string included key words for the topics “advanced cancer,” “cancer cachexia,” and “psychosocial effects.” Publications were selected by two reviewers. The search was complemented by a hand search. Results: Nineteen studies were included. The available information revealed mechanisms leading to, various presentations of, and coping strategies for psychosocial effects of cancer cachexia in both patients and their carers. Not all those affected manage the effects of the condition constructively. A number of clinically important adverse reactions have been identified. The main causes for negative psychosocial effects are a lack of knowledge of the irreversible nature of cancer cachexia and unsuccessful attempts to increase body weight with altered patterns of nutritional intake. Depending on patients' and their carers' coping resources, psychosocial effects may escalate or decrease. Early identification of psychosocial effects creates the potential for psychosocial interventions that improve the quality of life of those affected. Our analysis engendered a broader conceptualization of the psychosocial effects of cancer cachexia, leading to a number of suggestions for psychosocial interventions with the potential for providing relief. Conclusion: The concept of psychosocial effects in cancer cachexia has the potential to sensitize health care professionals to cachexia-related problems and inform their clinical management of the condition. [Copyright &y& Elsevier]

Abstract: Context: Symptom assessment by computers is only effective if it provides valid results and is perceived as useful for clinical use by the end users: patients and health care providers. Objectives: To identify factors associated with discontinuation, time expenditure, and patient preferences of the computerized symptom assessment used in an international multicenter data collection project: the European Palliative Care Research Collaborative-Computerized Symptom Assessment. Methods: Cancer patients with incurable metastatic or locally advanced disease were recruited from 17 centers in eight countries, providing 1017 records for analyses. Observer-based registrations and patient-reported measures on pain, depression, and physical function were entered on touch screen laptop computers. Results: The entire assessment was completed by 94.9% (n =965), with median age 63 years (range 18–91 years) and median Karnofsky Performance Status (KPS) score of 70 (range 20–100). Predictive factors for noncompletion were higher age, lower KPS, and more pain (P ≤0.012). Time expenditure among completers increased with higher age, male gender, Norwegian nationality, number of comorbidities, and lower physical functioning (P ≤0.007) but was inversely related to pain levels and tiredness (P ≤0.03). Need for assistance was predicted by higher age, nationality other than Norwegian, lower KPS, and lower educational level (P <0.001). More than 50% of patients preferred computerized assessment to a paper and pencil version. Conclusion: The high completion rate shows that symptom assessment by computers is feasible in patients with advanced cancer. However, reduced performance status reduces compliance and increases the need for assistance. Future work should aim at identifying the minimum set of valid screening questions and refine the software to optimize symptom assessment and reduce respondent burden in frail patients. [Copyright &y& Elsevier]

Abstract: Context: In surgical and clinical oncology, there is a growing need for patient-centered outcomes that are responsive, meaningful, and fit for purpose. Objectives: The aim of this study was to validate physical activity (PA) monitoring as a responsive outcome measure at different stages of disease and treatment, by verifying correlations between PA, performance score, and quality of life (QoL). Methods: Daily life PA of 162 cancer patients, monitored by a device that records time sitting/lying, time standing, time walking, number of steps taken, and walking cadence, was compared with 20 healthy volunteers. In a subgroup of patients, functional status and QoL were assessed using the World Health Organization/Eastern Cooperative Oncology Group and the Karnofsky Performance Status scores and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) questionnaire. Results: The PA of patients with resectable gastrointestinal cancer did not differ significantly from controls. In contrast, patients with advanced cancer took 45% fewer steps and spent an extra 2.8 hours/day lying/sitting (P =0.001). Patients undergoing neoadjuvant chemotherapy and surgery (5–6 weeks after operation) experienced a similar reduction in PA. There were significant correlations between PA and the physical and role domains as well as fatigue subscale of the EORTC QLQ-C30 scale. Conclusion: Objective PA scores correlate significantly with disease stage, functional status, and QoL of patients with cancer. Therefore, activity monitoring can make meaningful objective estimates of patient function in response to cancer and its treatment and may provide surrogate outcomes of QoL. [Copyright &y& Elsevier]

Background: In patients with advanced, incurable cancer, anticancer treatment may be used to alleviate cancer-related symptoms, but monitoring of them in daily practice is rarely done. We aim to test the effectiveness of a real-time symptom and syndrome assessment using the E-MOSAIC software installed in handheld computer generating a longitudinal monitoring sheet (LoMoS) provided to the oncologists in a phase III setting. Methods: In this prospective multicentre cluster randomized phase-III trial patients with any incurable solid tumor and having defined cancer related symptoms, who receive new outpatient chemotherapy in palliative intention (expected tumor-size response rate ≤20%) are eligible. Immediately before the weekly visit to oncologists, all patients complete with nurse assistance the E-MOSAIC Assessment: Edmonton Symptom Assessment Scale, ≤3 additional symptoms, estimated nutritional intake, body weight, Karnofsky and medications for pain and cachexia. Experienced oncologists will be randomized to receive the LoMoS or not. To minimize contamination, LoMoS are removed from the medical charts after visits. Primary endpoint is the difference in global quality of life (items 29 & 30 of EORTC-QlQ-C30) between baseline and last study visit at week 6, with a 10 point between-arm difference considered to be clinically relevant. 20 clusters (=oncologists) per treatment arm with 4-8 patients each are aimed for to achieve a significance level of 5% and a power of 80% in a mixed model approach. Selected co- variables are included in the model for adjustment. Secondary endpoints include patient-perceived patient-physician communication symptom burden over time, and oncologists' symptom management performance (predefined thresholds of symptoms compared to oncologists' pharmacological, diagnostic or counselling actions [structured chart review]). Discussion: This trial will contribute to the research question, whether structured, longitudinal monitoring of patients' multidimensional symptoms, indicators for symptom management, and clinical benefit outcomes can influence patients' quality of life and symptom distress, in a setting of routine oncology practice. Trial registration: Current Controlled Trials NCT00477919 [ABSTRACT FROM AUTHOR]

Abstract: Background: The concept of cancer-related anorexia/cachexia is evolving as its mechanisms are better understood. To support consensus processes towards an updated definition and classification system, we systematically reviewed the literature for items and domains associated with involuntary weight loss in cancer. Methods: Two search strings (cachexia, cancer) explored five databases from 1976 to 2007. Citations, abstracts and papers were included if they were original work, in English/German language, and explored an item to distinguish advanced cancer patients with variable degrees of involuntary weight loss. The items were grouped into the 5 domains proposed by formal expert meetings. Results: : Of 14,344 citations, 1275 abstracts and 585 papers reviewed, 71 papers were included (6325 patients; 40–50% gastrointestinal, 10–20% lung cancer). No single domain or item could consistently distinguish cancer patients with or without weight loss or having various degrees of weight loss. Anorexia and decreased nutritional intake were unexpectedly weakly related with weight loss. Explanations for this could be the imprecise measurement methods for nutritional intake, symptom interactions, and the importance of systemic inflammation as a catabolic drive. Data on muscle mass and strength is scarce and the impact of cachexia on physical and psychosocial function has not been widely assessed. Conclusions: Current data support a modular concept of cancer cachexia with a variable combination of reduced nutritional intake and catabolic/hyper-metabolic changes. The heterogeneity in the literature revealed by this review underlines the importance of an agreed definition and classification of cancer cachexia. [Copyright &y& Elsevier]

Abstract: Context: The Edmonton Symptom Assessment System (ESAS) is a widely used, self-report symptom intensity tool for assessing nine common symptoms in palliative care, with ratings ranging from 0 (none, best) to 10 (worst). Based on a “think-aloud” study of 20 advanced cancer patients, the ESAS was revised (ESAS-r). Objectives: To compare the consistency of patients’ symptom ratings and obtain patient perspectives regarding ease of understanding and completion between the ESAS and ESAS-r. Methods: Cognitively intact patients (n =160) were recruited from eight palliative care sites in Canada and Switzerland, using cross-sectional sampling (20 per site). Consenting patients completed the ESAS, ESAS-r, and a structured interview. Intraclass correlation coefficients (ICCs) were calculated to assess rating consistency. Results: In total, 1046 patients were screened. One hundred sixty were enrolled and evaluable (female 51%, median age 61 [range 34–92], lung cancer 26%, gastrointestinal cancer 22%). Mean ESAS scores ranged from 1.2 (nausea, standard deviation [SD] 2.1) to 4.3 (appetite, SD 3.3). ICCs ranged from 0.65 to 0.83, with lowest scores (<0.8) for drowsiness, appetite, and well-being. Although most patients rated both versions as very easy or easy to understand and complete, the ESAS-r was significantly easier to understand than the ESAS (P =0.008). Significantly, more patients preferred the ESAS-r (39%) than the ESAS (14%, P <0.001) because of its definitions, clarity, and format. Conclusion: The ESAS-r retains core elements of the ESAS, with improved interpretation and clarity of symptom intensity assessment. It represents the next generation of ESAS development, with further validation recommended for drowsiness, appetite, and well-being. [Copyright &y& Elsevier]

Abstract: Assessment of individual patients’ distress is a cornerstone of clinical care for advanced cancer. Patients’ ability to fill out lengthy questionnaires is compromised by many factors. Computer-adaptive tests (CAT) offer a promising approach to developing tailored instruments, that administer only items relevant to the individual patient. A systematic review of the literature about CATs in medical databases was conducted. Based on the results, a method for developing a CAT was designed that requires nine steps: (1) build an item pool; (2) administer the items to a predefined sample in a calibration study; (3) eliminate inappropriate items; (4) examine whether all items are influenced by a single dominant trait; (5) calibrate the items to the best-fitting item response theory (IRT) model; (6) evaluate items’ parameter equivalence across subgroups; (7) build an item bank with the calibrated items; (8) develop the CAT; and (9) pilot test the developed CAT. CAT offers the chance to extend the usefulness of patient-reported outcome (PRO) measurements from clinical studies to daily clinical practice. [Copyright &y& Elsevier]

Background: Symptoms tend to occur in what have been called symptom clusters. Early symptom cluster research was imprecise regarding the causal foundations of the coordinations between specific symptoms, and was silent on whether the relationships between symptoms remained stable over time. This study develops a causal model of the relationships between symptoms in cancer palliative care patients as they approach death, and investigates the changing associations among the symptoms and between those symptoms and well-being. Methods: Complete symptom assessment scores were obtained for 82 individuals from an existing palliative care database. The data included assessments of pain, anxiety, nausea, shortness of breath, drowsiness, loss of appetite, tiredness, depression and well-being, all collected using the Edmonton Symptom Assessment System (ESAS). Relationships between the symptoms and well-being were investigated using a structural equation model. Results: The model fit acceptably and explained between 26% and 83% of the variation in appetite, tiredness, depression, and well-being. Drowsiness displayed consistent effects on appetite, tiredness and well-being. In contrast, anxiety's effect on well-being shifted importantly, with a direct effect and an indirect effect through tiredness at one month, being replaced by an effect working exclusively through depression at one week. Conclusion: Some of the causal forces explaining the variations in, and relationships among, palliative care patients' symptoms changed over the final month of life. This illustrates how investigating the causal foundations of symptom correlation or clustering can provide more detailed understandings that may contribute to improved control of patient comfort, quality of life, and quality of death. [ABSTRACT FROM AUTHOR]

Chronic nausea occurs in most patients with advanced cancer. This study was done to assess the antiemetic effects of dexamethasone in patients with chronic nausea refractory to metoclopramide. Secondary outcomes included appetite, fatigue, and pain. Fifty-one patients who had nausea (≥ 3/10 on a 0-10 scale) for ≥ 2 weeks despite 48 hours of oral metoclopramide therapy (40-60 mg/day) were enrolled. Patients received 20 mg/day dexamethasone (DM) orally (n=25) or placebo (n=26) for severe nausea in addition to metoclopramide (60 mg/day orally). At baseline the mean nausea intensity ratings in the DM and placebo groups were 8.0 and 7.4. At Day 8 they were 2.1 and 2.0, respectively. At Day 3 and Day 8, the mean difference in nausea intensity for the DM and placebo groups was 4.5 and 2.9 (P=0.16) and 5.9 and 5.7 (P=0.85), respectively. Improvement in appetite and fatigue were observed on Day 3 and Day 8 in both groups as compared with the baseline. Pain, vomiting, well-being, and quality of life remained unchanged in both groups at both times. We conclude that DM was not superior to placebo in the management of chronic nausea in our patients with advanced cancer. [Copyright &y& Elsevier]

Opioid-induced sedation is a major complication in patients with cancer pain. This study assessed the effectiveness of donepezil in opioid-induced sedation and related symptoms in patients with cancer pain. Twenty-seven patients who were receiving strong opioids for pain and reported sedation were enrolled. Donepezil 5 mg was given every morning for 7 days. Changes between baseline and Day 7 in sedation, pain, fatigue and other symptoms were evaluated using the Edmonton Symptom Assessment Scale. Fatigue was also measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Overall usefulness of donepezil was measured by the patient at the end of the study. In 20 evaluable patients, sedation, fatigue, anxiety, well-being, depression, anorexia and problems with sleep were significantly improved. Side effects included nausea, vomiting, diarrhea, muscle and abdominal cramps, and anorexia. Overall, however, the treatment was well tolerated. Donepezil appears to improve sedation and fatigue in patients receiving opioids for cancer pain. Randomized controlled trials of this agent are justified. [ABSTRACT FROM AUTHOR]

Perception of discomfort in dying patients is a risk factor for distress and bereavement among relatives. This study determined the perception of discomfort, the frequency of observed behaviors, and their association among relatives and among nurses who care for unresponsive dying patients. Sixty unresponsive dying patients' relatives and their nurses were asked to evaluate patient discomfort levels, the frequencies of six observed behaviors, and the suspected reasons for the patient discomfort. The mean levels of perceived discomfort were similar, but the association was poor between the relatives and the nurses. Relatives reported significantly more observed behaviors and associated more pain as a reason for patient discomfort than did nurses. The findings suggest that relatives are intensely attuned to their loved ones' conditions and reactions, and nurses' responses are fairly similar. Further research is warranted, however, to distinguish between the distress that the relatives perceive and the actual suffering of patients. [ABSTRACT FROM AUTHOR]

Perception of discomfort in dying patients is a risk factor for distress and bereavement among relatives. This study determined the perception of discomfort, the frequency of observed behaviors, and their association among relatives and among nurses who care for unresponsive dying patients. Sixty unresponsive dying patients'' relatives and their nurses were asked to evaluate patient discomfort levels, the frequencies of six observed behaviors, and the suspected reasons for the patient discomfort. The mean levels of perceived discomfort were similar, but the association was poor between the relatives and the nurses. Relatives reported significantly more observed behaviors and associated more pain as a reason for patient discomfort than did nurses. The findings suggest that relatives are intensely attuned to their loved ones'' conditions and reactions, and nurses'' responses are fairly similar. Further research is warranted, however, to distinguish between the distress that the relatives perceive and the actual suffering of patients. [Copyright &y& Elsevier]

Background: Early intervention against cachexia necessitates a predictive model. The aims of this study were to identify predictors of cachexia development and to create and evaluate accuracy of a predictive model based on these predictors. Methods: A secondary analysis of a prospective, observational, multicentre study was conducted. Patients, who attended a palliative care programme, had incurable cancer and did not have cachexia at baseline, were amenable to the analysis. Cachexia was defined as weight loss (WL) > 5% (6 months) or WL > 2% and body mass index< 20 kg/m2. Clinical and demographic markers were evaluated as possible predictors with Cox analysis. A classification and regression tree analysis was used to create a model based on optimal combinations and cut-offs of significant predictors for cachexia development, and accuracy was evaluated with a calibration plot, Harrell's c-statistic and receiver operating characteristic curve analysis. Results: Six-hundred-twenty-eight patients were included in the analysis. Median age was 65 years (IQR 17), 359(57%) were female and median Karnofsky performance status was 70(IQR 10). Median follow-up was 109 days (IQR 108), and 159 (25%) patients developed cachexia. Initial WL, cancer type, appetite and chronic obstructive pulmonary disease were significant predictors (p ≤ 0.04). A five-level model was created with each level carrying an increasing risk of cachexia development. For Risk-level 1-patients (WL < 3%, breast or hematologic cancer and no or little appetite loss), median time to cachexia development was not reached, while Risk-level 5-patients (WL 3–5%) had a median time to cachexia development of 51 days. Accuracy of cachexia predictions at 3 months was 76%. Conclusion: Important predictors of cachexia have been identified and used to construct a predictive model of cancer cachexia. Trial registration: ClinicalTrials.gov Identifier: NCT01362816. [ABSTRACT FROM AUTHOR]

Context Cancer cachexia occurs in most patients suffering from solid malignancies. Recent works suggest paraneoplastic mechanisms. Empirical studies also found autonomic dysfunction in cancer patients, but comprehensive evaluation of the peripheral nervous system is lacking. Objectives To further understand the role of the autonomic and peripheral nervous system in cancer cachexia to guide treatment. Methods We prospectively investigated cachectic cancer patients for parasympathetic autonomic dysfunction with a time-domain–based analysis of heart rate variability (breathing at rest, deep breath, and in response to the Valsalva maneuver). Blood pressure changes after the Valsalva maneuver were used as a marker of the sympathetic noradrenergic system. Orthostatic hypertension was investigated in response to active standing. We used a noninvasive continuous beat-to-beat heart rate assessment and blood pressure monitoring. The sympathetic cholinergic nervous system was evaluated with the sympathetic skin response. A detailed neurological examination, nerve conduction studies, and electromyography also were conducted. Results A total of 13 patients were enrolled (median age 66 years). Median time from inclusion until death was 3.5 months. About 12 of the 13 patients showed abnormal results in at least one autonomic test. Sympathetic noradrenergic and cholinergic abnormalities were discovered in six patients each and five patients had orthostatic hypotension. Only one patient showed abnormal results in parasympathetic cholinergic tests. Asymptomatic large fiber polyneuropathy was detected in eight patients. Conclusion Large fiber polyneuropathy coincides with autonomic dysfunction in cachectic cancer patients. Our findings suggest a relevant role of sympathetic impairment in cancer cachexia. [ABSTRACT FROM AUTHOR]

Background: Symptoms tend to occur in what have been called symptom clusters. Early symptom cluster research was imprecise regarding the causal foundations of the coordinations between specific symptoms, and was silent on whether the relationships between symptoms remained stable over time. This study develops a causal model of the relationships between symptoms in cancer palliative care patients as they approach death, and investigates the changing associations among the symptoms and between those symptoms and well-being.Methods: Complete symptom assessment scores were obtained for 82 individuals from an existing palliative care database. The data included assessments of pain, anxiety, nausea, shortness of breath, drowsiness, loss of appetite, tiredness, depression and well-being, all collected using the Edmonton Symptom Assessment System (ESAS). Relationships between the symptoms and well-being were investigated using a structural equation model.Results: The model fit acceptably and explained between 26% and 83% of the variation in appetite, tiredness, depression, and well-being. Drowsiness displayed consistent effects on appetite, tiredness and well-being. In contrast, anxiety's effect on well-being shifted importantly, with a direct effect and an indirect effect through tiredness at one month, being replaced by an effect working exclusively through depression at one week.Conclusion: Some of the causal forces explaining the variations in, and relationships among, palliative care patients' symptoms changed over the final month of life. This illustrates how investigating the causal foundations of symptom correlation or clustering can provide more detailed understandings that may contribute to improved control of patient comfort, quality of life, and quality of death. [ABSTRACT FROM AUTHOR]