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Background: Pain is a prevalent symptom in patients with advanced cancer. Recognition of prognostic factors associated with pain intensity, could help provide better assessment, leading to better pain management. Aim: identifying prognostic factors which could guide improvements on cancer pain classification. Design: a prospective observational study on chronic cancer pain, exploring the association between average mean pain intensity during a 28 days study follow-up and patients’ clinical and pain-related characteristics, including pain syndromes. To evaluate these associations, a mixed model was built. Setting/participants: Patients attending a Palliative Care and Pain Outpatient Clinic from May 2015 to June 2019 were screened. Patients with moderate to severe cancer pain who were already receiving or needed treatment with third step WHO ladder opioids were enrolled in the study. Data from 342 patients with at least one follow-up visit were analyzed. Results: Pain intensity decreased significantly for all patients during time ( p Conclusions: The recognition of specific pain syndromes may help to better classify cancer pain.

Few studies have investigated the needs of patients with metastatic breast cancer (MBC), and none have been conducted in Italy. Three categories of needs have been identified from the literature: information, support, and practical resources. The present study aims to achieve an in-depth understanding of the patients' needs related to the MBC care pathway. In-depth interviews were conducted and analyzed by thematic analysis. The participants were 9 women with MBC (age range 36-74) who were enrolled at the Fondazione IRCCS Istituto Nazionalde dei tumori, in Milan. The analysis enabled us to identify four themes (which reflect the needs of the participants), each divided into numerous sub-themes: (1) the need for clinical recognition, (2) the need for more attention from healthcare professionals, (3) the need for more and better services to be available at the hospital, (4) the need for specific public health policies. Since the metastatic phase of breast cancer seems to elicit additional, specific needs and multi-level management, changes in attitudes and multidisciplinary practices should be tested in order to ascertain how these needs can be met.

Context Inflammation is proposed to influence tumor response in radiotherapy (RT). Clinical studies to investigate the relationship between inflammatory markers and RT response is warranted to understand the variable RT efficacy in patients with painful bone metastases. Objectives To evaluate the association between inflammatory markers and analgesic response to RT in patients with painful bone metastases. Methods Adult patients from 7 European study sites undergoing RT for painful bone metastases were included in this prospective and longitudinal analysis. The association between RT response and 17 inflammatory markers at baseline, as well as the association between RT response and the changes observed in inflammatory markers between baseline and three and eight weeks after RT, was analyzed with univariate regression analyses. Baseline analyses were adjusted for potential clinical predictors of RT response. Results None of the inflammatory markers were significantly associated with an upcoming RT response in the analysis of 448 patients with complete baseline data. In patients available for follow-up, the three-week change in TNF (P 0.017), IL-8 (P 0.028), IP-10 (P 0.032), eotaxin (P 0.043), G-CSF (P 0.033) and MCP-1 (P 0.002) were positively associated with RT response, while the three-week change in CRP (P 0.006) was negatively associated. Conclusion Results from this study show an association between RT response and change in pro-inflammatory mediators and indicate that inflammation may be important to achieve an analgesic RT response in patients with painful bone metastases. None of the investigated inflammatory markers were found to be pre-treatment predictors of RT response.

ObjectivesDuring the COVID-19 pandemic, telemedicine (TM) emerged as an important mean to reduce risks of transmission, yet delivering the necessary care to patients. Our aim was to evaluate feasibility, characteristics and satisfaction for a TM service based on phone/video consultations for patients with cancer attending an outpatient palliative care clinic during COVID-19 pandemics.MethodsA longitudinal observational study was conducted from April to December 2020. Consecutive patients were screened for video consultations feasibility. Either patients or their caregivers received video/phone consultations registering reason and intervention performed. Those contacted at least twice were eligible for experience of care assessment.ResultsVideo consultations were feasible in 282 of 572 screened patients (49%, 95% CI 45% to 52%); 112 patients among the 572 had at least two phone/video consultations and 12 of them had one or more video consultations. Consultations were carried out with patients (56%), caregivers (30%) or both (14%). 63% of the consultations were requested by the patients/caregivers. Reasons for consultation included uncontrolled (66%) or new symptom onset (20%), therapy clarifications (37%) and updates on diagnostic tests (28%). Most interventions were therapy modifications (70%) and appointments’ rescheduling (51%). 49 patients and 19 caregivers were interviewed, reporting good care experience (average of 1–5 satisfaction score of 3.9 and 4.2, respectively). The majority (83% and 84%) declared they would use TM after the pandemics.ConclusionsAlthough feasibility is still limited for some patients, TM can be a satisfactory alternative to in-person visits for palliative care patients in need of limiting access to the hospital.

Objective: This study reviews the scientific literature to identify and describe which assessment tools (ATs) are used in pediatric oncology and neuro-oncology rehabilitation and which development neuropsychomotor (DNPM) ATs were built for children with central nervous system (CNS) tumors. Methods: A systematic review was performed searching PubMed, CINAHL, PEDro, Science Direct, and Catalog of National Institute of Tumors databases and specialized journals. The search covered 7 years (2010–2017) and used relevant keywords in different combinations. A further search was carried out on DNPM rehabilitation manuals and academic thesis. Results: The review retrieved 35 eligible articles containing 63 ATs. The most common ATs were the Behavioral Rating Inventory of Executive Function (BRIEF) and the Wechsler Intelligence Scale for Children (WISC). Most of the ATs covered a single area of child development among behavioral/psychological, cognitive, and motor areas. A total of 159 ATs were found in manuals and thesis, and only 17 of them were already identified in the journal search. None of the ATs identified in both searches had been specifically developed for children with CNS tumor. Conclusion: The results highlight the need to develop and validate a global multidimensional AT for children with CNS tumor, overcoming the fragmentation of the assessment procedures and promoting standardized rehabilitation protocols.

Contains fulltext : 205187.pdf (Publisher’s version ) (Closed access) BACKGROUND & AIMS: Home parenteral nutrition-quality of life (HPN-QOL((c))) is a self-assessment tool for the measurement of QOL in patients on HPN. The aims of this study were: to re-assess the basic psychometric properties of the HPN-QOL((c)) in a multinational sample of adult patients; to provide a description of QOL dimensions by short and long HPN treatment duration; to explore clinical factors potentially associated to QOL scores. METHODS: Patients (n = 699) from 14 countries completed the HPN-QOL((c)). The questionnaires were analysed to evaluate data completeness, convergent/discriminant validity and internal-consistency reliability. The association of overall QOL and HPN treatment duration as well as other clinical factors were investigated using multivariable linear regression models. RESULTS: The analysis of the multitrait-scaling and internal consistency indicates a good fit with the questionnaire structure for most items. Item discriminant validity correlation was satisfactory and psychometric evaluation of the HPN-QOL((c)) in the different English, French and Italian language patient sub-groups confirmed psychometric equivalence of the three questionnaire versions. The results of the multivariable linear regression showed that QOL scores were significantly associated with HPN duration (better in long-term), underlying disease (better in Crohn's disease and mesenteric ischaemia) and living status (worse in living alone) and, after adjusting for the other factors, with the number of days of HPN infusion per week. CONCLUSIONS: The HPN-QOL((c)), is a valid tool for measurement of QOL in patients on HPN, to be used in the clinical practice as well as in research.

Background Radiationtherapy (RT) provide pain reduction in about 60% of patients with painful bone metastases. Studies have identified demographic and clinical characteristics to predict RT response, but no model is clinical useful. Tumor characteristics and inflammation can influence cancer induced bone pain, but the association with RT response are not studied. We test if tumor characteristics and the inflammation marker CRP improve prediction of RT response. Methods We included adult patients receiving RT for painful bone metastases in a multicenter, multinational longitudinal observational study. The primary endpoint was analgesic response within 8 weeks after RT defined according to current guidelines. Seventeen independent potential predictor variables assessed at baseline included patient demographics, RT administration, pain characteristics and treatment, cancer diagnosis, tumor characteristics, depression and inflammation (CRP). Multivariate logistic regression analysis with multiple imputation of missing data were applied to identify predictors of RT response. Results are reported as odds ratios (OR) and 95% confidence intervals (CI). Results 565 eligible patients were enrolled, 424 patients (75%) had complete data on the variables of interest and multiple imputation allowed the final regression models to be carried out on 513 patients (91%). 232 patients (41%, CI 37%-45%) responded to RT. Higher Karnofsky performance status (OR 1.45, CI 1.21-1.73), breast cancer (OR 2.61, CI 1.20-5.69) and prostate cancer (OR 2.64, CI 1.24-5.63) (compared to GI cancer), presence of soft tissue expansion (OR 1.78, CI 1.13-2.81) and higher maximum pain intensity at the radiated site (OR 1.1, CI 1.00-1.21) were significant predictors of positive RT response, while the use of steroids was a negative predictor (OR 0.62, CI 0.42-0.93). The discriminative ability of the model was moderate, with C-statistics 0.70. Conclusions This study supports previous findings that higher performance status, cancer diagnosis and higher baseline pain intensity predict analgesic RT response. The study presents new data showing that presence of soft tissue expansion predicts RT response and that CRP is not significantly associated with analgesic RT response. Clinical trial identification NCT02107664 (Date of registration April 8, 2014). Legal entity responsible for the study Pal Klepstad. Funding The European Palliative Care Research Centre (PRC). Disclosure All authors have declared no conflicts of interest.

Central Nervous System (CNS) tumors are the most common pediatric solid tumor and development neuro psychomotor (DNPM) therapy can contribute to the rehabilitation of these children. This paper describes the development of a DNPM multidimensional assessment grid for children with CNS tumor (DNPM-CNS grid). The development process included 4 phases: (P1) literature review and grid development (Version 1.0), (P2) two rounds consultations with experts (Version 1.1 and 2.0), (P3) field testing, (P4) final revision (Version 3.0). (P1) The DNPM-CNS grid was developed based on previous tools and manuals and on clinical experience with this patient population. (P2) A total of 52 questionnaires were filled in by experts about relevance of assessment areas, pertinence, comprehensibility and feasibility of the grid. Average scores ranged from 7.6 to 10. (P3) At case level, good inter-rater agreement scores (78%) and limited non-evaluability rates (18%) emerged. At item level, 27% of items reached high disagreement and 26% high not-evaluability rates. The qualitative assessment was judged clinically useful for planning the neuro-oncology rehabilitation treatment and a good feasibility of the DNPM-CNS grid emerged both for preschool and school-age children. (P4) The final version of the grid consists of 8 assessment areas with 133 items. The DNPM-CNS grid is a comprehensive tool that can guide the overall DNPM assessment in a limited amount of time. It can be used as a screening tool to customize more specific assessments. Further research is needed to better characterize grid psychometric properties. Supplemental data for this article is available online at https://doi.org/10.1080/08880018.2021.1948648 .

Purpose Caring affects carers’ psychological and physical health, mortality, and quality of life (QoL) negatively. Lower spiritual QoL is associated with anxiety and depression, but the spiritual dimension is rarely investigated in carers. The present study aimed to explore which patient- and carer-related characteristics were associated with spiritual QoL in carers of patients with advanced cancer. Methods Secondary analyses were conducted using data from a prospective study investigating integration between oncology and palliative care. Adult patients with advanced cancer and their carers were included, and baseline data considering demographics, clinical characteristics, symptoms, social support, and religious meaning-making were registered. Spiritual QoL was measured using the Functional Assessment of Chronic Illness Therapy - Spiritual well-being (FACIT-Sp-12) questionnaire. Associations to spiritual QoL were explored by bivariate and multivariate regression models. Results In total, 84 carers were included, median age was 62.5 years, 52 (62%) were female, and the average spiritual QoL score was 23.3. In bivariate analyses, higher education, social support, and lower patients’ symptom burden were significantly associated with higher spiritual QoL. The multivariate regression model (n=77) had an explained variance (R2) = 0.34 and showed a significant association for social support, higher education, having children < 18 years living at home, and patient’s age. Conclusion The study indicates that spiritual QoL in carers were low and were negatively affected by several factors related to both carers and patients. However, there could be other important factors not yet described. Health care professionals should be aware of the known associated factors, as carers who hold these may need extra support. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

Primary retroperitoneal sarcoma (RPS) may require multivisceral resection (MVR). Clinical outcome (morbidity and renal function) and quality of life (QoL) are not as well reported as the oncologic outcome. Patients with primary RPS who underwent surgery between 2014 and 2016 were prospectively enrolled in an observational longitudinal study. At baseline, then at 4 and 12 months, the study measured Clavien–Dindo morbidity, estimated glomerular filtration rate (EGFR), EORTC QLQ-C30, QLQ-CR29, DN4 (neuropathic pain [NP]), lower-extremity functional scale (LEFS), and the brief pain inventory. The primary end point was the difference in global health status (GHS/QoL). The secondary end points were EGFR changes, difference in other QLQ-C30 scales, pain intensity, NP, and LEFS. The study is registered at ClinTrials.gov (NCT03480399). Of 74 patients, 58 were evaluable. Morbidity grade 3 or higher was 24.1%, and mortality was 1.3%. After nephrectomy, the mean 1-year EGFR change was −33.9%. The GHS/QoL at baseline was 58.6 and had increased of 6.9 points at 1 year, comparable with that of the general population. A transient worsening in pain and diarrhea had recovered at 12 months. Average pain was mild and did not differ at 12 months. However, NP was found in 41.4% of the patients and was significantly associated with resection of the psoas muscle. At baseline, LEFS was already lower than the normative value, and worsening after surgery was not clinically relevant. A QoL measure after MVR in primary RPS is complex and requires multiple tools. Whereas overall MVR is safe and associated with an improvement in GHS/QoL, chronic NP is frequent and deserves specific attention. Pre-surgery rehabilitation tracks may help to prevent or reduce chronic NP.

The comparison of 3 approaches with neuropathic cancer pain diagnosis demands that careful etiological assessment and standardized clinical criteria be applied to this clinical condition., Neuropathic cancer pain (NcP) is associated with worse treatment responses and specific therapy indications, but a standardized clinical diagnosis of NcP is still lacking. This is a prospective observational study on outpatients with cancer, comparing different clinical approaches with NcP evaluation. A three-step assessment of NcP was performed using DN4 (cutoff of 4), palliative care physician Clinical Impression, including etiology and pain syndrome identification, and Retrospective Clinical Classification by a board of specialists with the IASP Neuropathic Pain Special Interest Group criteria. Neuropathic cancer pain classification was specifically referred to pain directly due to cancer. Three hundred fifty patients were assessed, and NcP prevalence was 20% (95% confidence interval [CI] 15.9%-24.6%), 36.9%, (95% CI 31.6%-42.1%), and 28.6% (95% CI 23.8%-33.9%) according to DN4, Clinical Impression, and Retrospective Clinical Classification, respectively. Cohen's kappa concordance coefficient between DN4 and Retrospective Clinical Classification was 0.57 (95% CI 0.47-0.67), indicating moderate concordance. Higher percentages of discordance were found for specific pain syndromes such as pain due to deep soft tissue infiltration and pain associated with tenesmus. Disagreement among clinicians accounted also for different NcP diagnoses and highlighted lack of homogeneous clinical criteria. Rigorous application of etiological and syndrome diagnosis to explain pain cause, associated with standardized diagnostic criteria and assessment of pain characteristics, that is also specific for the cancer pain condition could improve clinical classification of NcP.

Background Several publications have addressed the need for a systematic integration of oncological care focused on the tumor and palliative care (PC) focused on the patient with cancer. The exponential increase in anticancer treatments and the high number of patients living longer with advanced disease have accentuated this. Internationally, there is now a persuasive argument that introducing PC early during anticancer treatment in patients with advanced disease has beneficial effects on symptoms, psychological distress, and survival. Methods This is a national cluster-randomized trial (C-RCT) in 12 Norwegian hospitals. The trial investigates effects of early, systematic integration of oncology and specialized PC in patients with advanced cancer in six intervention hospitals compared with conventional care in six. Hospitals are stratified on the size of local catchment areas before randomization. In the intervention hospitals, a three-part complex intervention will be implemented. The backbone of the intervention is the development and implementation of patient-centered care pathways that contain early, compulsory referral to PC and regular and systematic registrations of symptoms. An educational program must be completed before patient inclusion. A total of 680 patients with advanced cancer and one caregiver per patient are included when patients come for start of last line of chemotherapy, defined according to national treatment guidelines. Data registration, clinical variables, and patient- and caregiver-reported outcomes take place every 2 months for 1 year or until death. The primary outcome is use of chemotherapy in the last 3 months of life by comparing the proportion of patients who receive this in the intervention and control groups. Primary outcome is use of chemotherapy in the last 3 months before death, i.e. number of patients. Secondary outcomes are initiation, discontinuation and number of cycles, last 3 months of life, administration of other medical interventions in the last month of life, symptom burden, quality of life (QoL), satisfaction with information and follow-up, and caregiver health, QoL, and satisfaction with care. Discussion Results from this C-RCT will be used to raise the awareness about the positive outcomes of early provision of specialized palliative care using pathways for patients with advanced cancer receiving medical anticancer treatment. The long-term clinical objective is to integrate these patient-centered pathways in Norwegian cancer care. The specific focus on the patient and family and the organization of a predictable care trajectory is consistent with current Norwegian strategies for cancer care. Trial registration ClinicalTrials.gov, NCT03088202. Registered on 23 March 2017.

Background and aims The prevalence of pain in cancer patients are relatively high and indicate inadequate pain management strategies. Therefore, it is necessary to develop new methods and to improve implementation of guidelines to assess and treat pain. The vast improvement in information technology facilitated development of a computerized symptom assessment and decision support system (CCDS) - the Combat system - which was implemented in an outpatient cancer clinic to evaluate improvement in pain management. Methods We conducted a controlled before-and-after study between patient cohorts in two consecutive study periods: before (n = 80) and after (n = 134) implementation of the Combat system. Patients in the first cohort completed questionnaires with the paper-and-pencil method and this data was not shown to physicians. Patients in the latter cohort completed an electronic questionnaire by using an iPad and the data were automatically transferred and presented to physicians at point of care. Additionally, the system provided computerized decision support at point of care for the physician based on the electronic questionnaires completed by the patients, an electronic CRF completed by physicians and clinical guidelines. Results The Combat system did not improve pain intensity and there were no significant alterations in the prescribed dose of opiates compared to the cohort of patients managed without the Combat system. Conclusion The Combat system did not improve pain management. This may be explained by several factors, however, we consider lack of proper implementation of the CCDS in the clinic to be the most important factor. As a result, we did not manage to change the behaviour of the physicians in the clinic. Implications There is a need to conduct larger prospective studies to evaluate the efficacy of modern information technology to improve pain management in cancer patients. Before introducing new information technology in the clinics, it is important to have a well thought out implementation strategy. The trial is registered at Clinialtrials.gov, number NCT01795157.

Nausea and vomiting are often associated with opioid analgesia in cancer patients; however, only a subset of patients develop such side effects. Here, we tested the hypothesis that the occurrence of nausea and vomiting is modulated by the genetic background of the patients. Whole exome sequencing of DNA pools from patients with either low (n = 937) or high (n = 557) nausea and vomiting intensity, recruited in the European Pharmacogenetic Opioid Study, revealed a preliminary association of 53 polymorphisms. PCR-based genotyping of 45 of these polymorphisms in the individual patients of the same series confirmed the association for six SNPs in AIM1L, CLCC1, MUC16, PDE3A, POM121L2, and ZNF165 genes. Genotyping of the same 45 polymorphisms in 264 patients of the Italian CERP study, also treated with opioids for cancer pain, instead confirmed the association for two SNPs in ZNF568 and PDE3A genes. Only one SNP, rs12305038 in PDE3A, was confirmed in both series, although with opposite effects of the minor allele on the investigated phenotype. Overall, our findings suggest that genetic factors are indeed associated with nausea and vomiting in opioid-treated cancer patients, but the role of individual polymorphisms may be weak. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

Introduction Early access to cancer palliative care is recommended. Descriptions of structures and processes of outpatient palliative care clinics operated within smaller hospitals are scarce. This paper presents the development and operation of a fully integrated cancer and palliative care outpatient clinic at a local hospital in a rural region of Mid-Norway offering palliative care concurrent with cancer treatment. A standardized care pathway was applied. Methods Palliative care is in Norway part of the public healthcare system. Official recommendations recent years point out action points to improve delivery of palliative care. An integrated cancer and palliative care outpatient clinic at a local hospital and an innovative care delivery model was developed and operated in this setting. Patients were recruited for a descriptive study of the patient population. Clinical data were collected by clinical staff and 13 symptom intensities were reported by the patients. Results Cancer and palliative care were provided by one team of healthcare professionals trained in both fields. There was a close collaboration with the other departments at the hospital, with its affiliated tertiary hospital, and with community health and care services to provide timely referral, enhanced continuity, and improved coordination of care. Eighty-eight patients were included. Mean age was 65.6 years, the most common cancer diagnoses were digestive organs (22.7%), male genital organs (20.5%) or breast (25.0%), 75.0% had metastatic or locally advanced cancer, 59.1% were treated with non-curative intention and 93.1% had Karnofsky Performance Status ≥ 80%. Median scores of individual symptoms ranged from 0 to 3 (numerical rating scale, 0–10) and 61.0% reported at least one clinically significant symptom rating (≥ 4). Conclusion This delivery model of integrated outpatient cancer and palliative care is particularly relevant in rural regions allowing cancer patients access to palliative care earlier in the disease trajectory and closer to home, Plain Language Summary Palliative care is an important part of cancer care which aims at improving cancer patients’ symptom burden and quality of life and support their carers. Palliative care has traditionally been separated from cancer care. During the last decade, one has become aware of the benefits of introducing palliative care early and concurrent with cancer treatment. Most cancer patients are nowadays treated as outpatients. Availability of palliative care as a routine part of outpatient cancer clinics is therefore important. Most of the described models of early palliative care in cancer care are within large tertiary hospitals. Here it is described how early palliative care was delivered to cancer patients in an outpatient clinic in a smaller hospital in a rural region of Mid-Norway. In this integrated cancer and palliative care outpatient clinic, cancer and palliative care were provided by one team of healthcare professionals trained in both fields. The integrated outpatient clinic collaborated closely with the other hospital departments and with community health and care services. This was needed to be able to offer palliative care to all cancer patients in need of it, and closer to their home. Many of the patients attending the integrated outpatient clinic could not be cured for their cancer. They did not have many symptoms of their cancer, and they had a high functional status. This demonstrated that the integrated outpatient clinic in this local hospital was a relevant place to offer palliative care early and concurrent with cancer treatment before symptoms became severe.

Background The pain management index (PMI) was developed to combine information about the prescribed analgesics and the self-reported pain intensity in order to assess physicians’ response to patients’ pain. However, PMI has been used to explore undertreatment of cancer pain. The present study explores prevalence of negative PMI and its associations to clinical variables, including the patient-perceived wish for more attention to pain. Methods A single-center, cross-sectional, observational study of cancer patients was conducted. Data on demographics and clinical variables, as well as patient-perceived wish for more attention to pain, were registered. PMI was calculated. Negative PMI indicates that the analgesics prescribed might not be appropriate to the pain intensity reported by the patient, and associations to negative PMI were explored by logistic regression models. Results One hundred eighty-seven patients were included, 53% had a negative PMI score. Negative PMI scores were more frequent among patients with breast cancer (OR 4.2, 95% CI 1.3, 13.5), in a follow-up setting (OR 12.1, 95% CI 1.4, 101.4), and were inversely associated to low performance status (OR 0.14, 95% CI 0.03, 0.65). Twenty-two percent of patients with negative PMI scores reported that they wanted more focus on pain management, versus 13% among patients with a non-negative PMI score; the difference was not statistically significant. Conclusion A high prevalence of negative PMI was observed, but only 1/5 of patients with a negative PMI wanted more attention to pain by their physician. Our findings challenge the use of PMI as a measure of undertreatment of cancer pain.

Objectives Recent evidences show that early integration of palliative care (PC) with oncology has a positive impact on patients' quality of life, quality of care and costs. However, there is no consensus on outpatient referral criteria. Based on real world data, the aim of this study was to identify timing and factors associated to PC referral in patients with thoracic malignancies, and to describe their clinical care pathway. Material and Methods This observational retrospective study included consecutive patients with thoracic cancer, seen for the first time at the Thoracic Medical Oncology outpatient Clinic (TMOC) of our institution, between Jan.01-Dec.31 2014. Patients were followed-up till death or Dec.31 2015. Clinical and demographic data were collected from the electronic patient records. Cox regression models were used to evaluate the association between time to Palliative care Outpatient Clinic (POC) referral and performance status (PS), disease stage and symptoms at inclusion. Results 229 patients were eligible. 98 of them (43%; 95%IC 36%–49%) were referred to the POC within a median of 30 days (IQR 4–188). 80/98 patients received simultaneous anticancer therapy and PC. Univariable analysis showed that the hazard ratio (HR) of being referred to POC was significantly higher for patients with worse PS (HR = 4.5), more advanced disease stage (HR = 3.1), pain (HR = 4.9), dyspnea (HR = 2.5) and cough (HR = 2.2). The multivariable model confirmed independent prognostic value for PS, disease stage and pain. On Dec.31, 2015, 25/98 patients were still alive, 8 were lost at follow up and 65 had died. Among the latter, 61% died with hospice or home care, and, in the last 30 days of life, 16% received chemotherapy and 29% were admitted to hospital. Conclusions Our results suggest considering symptom burden, PS and disease stage as screening criteria for referral to PC in patients with thoracic malignancies.

Context Few studies have addressed the impact of previous opioid exposure on the effect of opioids for the treatment of severe cancer pain episodes. Objectives We aimed to test whether previous exposure to higher opioid doses was associated with a reduced analgesic effect of fentanyl sublingual tablets (FST) and subcutaneous morphine (SCM) and whether it had an influence on their relative effect. Methods This is a secondary analysis of a placebo-controlled randomized trial comparing 100 μg FST with 5 mg SCM for the acute treatment of severe cancer pain episodes. The effect of previous opioid exposure (oral morphine equivalent daily dose from 20 to 120 mg) on pain intensity difference (PID) and side effects at 30 and 60 minutes after administration (PID 0–30 minutes, PID 0–60 minutes, and adverse events 30–60 minutes) and on re-medication for inefficacy, was studied by multivariable linear and logistic regression models and statistical tests for interaction. Results A total of 114 patients were enrolled. Results indicate modest and nonstatistically significant effect of previous opioid exposure on all the outcomes examined (P = 0.11, P = 0.35, P = 0.07, and P = 0.52, respectively, for PID 0–30 minutes, re-medication, PID 0–60 minutes, and adverse events 30–60 minutes). Nonstatistically significant tests for interaction for all models indicated a lack of impact of previous opioid exposure on the difference in the analgesic effect between treatments. Conclusion In this study, we could not demonstrate an effect of previous opioid exposure, from 20 to 120 mg oral morphine equivalent daily dose, on the absolute and relative efficacy and tolerability of 100 μg FST and 5 mg SCM for severe cancer pain episodes.

Context Cancer pain can appear with spikes of higher intensity. Breakthrough cancer pain (BTCP) is the most common term for the transient exacerbations of pain, but the ability of the nomenclature to capture relevant pain variations and give treatment guidance is questionable. Objectives To reach consensus on definitions, terminology, and subclassification of transient cancer pain exacerbations. Methods The most frequent authors on BTCP literature were identified using the same search strategy as in a systematic review and invited to participate in a two-round Delphi survey. Topics with a low degree of consensus on BTCP classification were refined into 20 statements. The participants rated their degree of agreement with the statements on a numeric rating scale (0–10). Consensus was defined as a median numeric rating scale score of ≥7 and an interquartile range of ≤3. Results Fifty-two authors had published three or more articles on BTCP over the past 10 years. Twenty-seven responded in the first round and 24 in the second round. Consensus was reached for 13 of 20 statements. Transient cancer pain exacerbations can occur without background pain, when background pain is uncontrolled, and regardless of opioid treatment. There exist cancer pain exacerbations other than BTCP, and the phenomenon could be named “episodic pain.” Patient-reported treatment satisfaction is important with respect to assessment. Subclassification according to pain pathophysiology can provide treatment guidance. Conclusion Significant transient cancer pain exacerbations include more than just BTCP. Patient input and pain classification are important factors for tailoring treatment. This is the authors' accepted and refereed manuscript to the article.

Purpose Immediate transfer of patient-reported outcome measures (PROMs) for use in medical consultations is facilitated by electronic assessments. We aimed to describe the rationale and development of Eir version 3 (EirV3), a computer-based symptom assessment tool for cancer, with emphasis on content and user-friendliness. Methods EirV3’s specifications and content were developed through multiprofessional, stepwise, and iterative processes (from 2013 to 2016), with literature reviews on traditional and electronic assessment and classification methods, formative iterative usability tests with end-users, and assessment of patient preferences for paper versus electronic assessments. Results EirV3 has the following two modules: Eir-Patient for PROMs registration on tablets and Eir-Doctor for presentation of PROMs in a user-friendly interface on computers. Eir-Patient starts with 19 common cancer symptoms followed by specific, in-depth questions for endorsed symptoms. The pain section includes a body map for pain location and intensity, whereas physical functioning, nutritional intake, and well-being are standard questions for all. Data are wirelessly transferred to Eir-Doctor. Symptoms with intensity scores ≥ 3 (on a 0 to 10 scale) are marked in red, with brighter colors corresponding to higher intensity, and supplemented with graphs displaying symptom development over time. Usability results showed that patients and health care providers found EirV3 to be intuitive, easy to use, and relevant. When comparing PROM assessments on paper versus tablets (n = 114), 19% of patients preferred paper, 41% preferred tablets, and 40% had no preference. Median intraclass correlation coefficient between paper and tablets (0.815) was excellent. Conclusion Iterative test rounds followed by continuous improvements led to a user-friendly, applicable symptom assessment tool, EirV3, developed for and by end-users. EirV3 is undergoing international testing of clinical and cross-cultural adaptability.

Purpose A clinical care pathway for pain management in a palliative care unit was studied with outcomes related to patients, physicians, and health care service. Mandatory use of patient-reported outcome measures (PROMs) and physician-directed decision support (DS) were integrated parts of the pathway. Methods Adult cancer patients with pain intensity (PI) ≥ 5 (NRS 0–10) at admission were eligible. The patients reported average and worst PI at admission, day four, and discharge. The physicians completed the DS at admission and day four. The DS presented potential needs for treatment changes based on pain severity and pathophysiology. The physicians reported treatment changes due to input from the DS system. The two primary outcomes were average and worst PI changes from admission to discharge. Hospital length of stay (LOS) was registered. Results Of 52 included patients, 41 were discharged alive. For those, the mean average PI at admission and at discharge was 5.8 and 2.4, respectively, a reduction of 3.4 points (CI 95% 2.7–4.1). The corresponding worst pain intensities were 7.9 and 3.8, a reduction of 4.1 points (CI 95% 3.4–4.8). The physicians completed DS forms for all patients. Fifty-five percent (CI 95% 41–69) of the patients had pain intervention changes based on the DS. A significant reduction in LOS (4.4 days, CI 95% 0.5–8.3) was observed during the study period. Conclusions The interventions were implemented according to the intentions and PI was reduced as hypothesized. For evaluation of generalizability, the interventions should be studied in other settings and with a controlled design.

Umberto Maria Musazzi,1 Paolo Rocco,1 Cinzia Brunelli,2,3 Luisa Bisaglia,4 Augusto Caraceni,2,3 Paola Minghetti1 1Department of Pharmaceutical Sciences, University of Milan, Milan, Italy; 2Palliative Care, Pain Therapy and Rehabilitation Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy; 3European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; 4Department of Statistical Sciences, University of Padua, Padua, Italy Purpose: In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors – such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies – on opioids sales to community pharmacies in Italy, focusing on the time period 2000–2010. Materials and methods: Five opioids were considered: codeine, tramadol, buprenorphine, morphine, and fentanyl. The analysis is based on sales data collected at wholesale distributors. For each one of the five drugs, time series of the number of Defined Daily Doses per thousand inhabitants per day in the period 2000–2010 were analyzed, and an estimation of breakpoints was performed using segmented linear regression. Results: Drug sales underwent a sharp increase in 2000–2010, although on different scales. Segmented regression analysis highlighted different potential breakpoints, corresponding to either a significant change in value and/or in slope. Sales of the five opioids were affected by at least one relevant event, often due to a synergy of regulatory, marketing, and technological factors. The effect of reimbursement changes has proved important. Conclusion: Between 2000 and 2010, regulatory, technological, and reimbursement changes significantly influenced opioid sales to community pharmacies in Italy. The sales of relatively new drug products seem to be less influenced by changes in reimbursement and regulatory policies than that of more established products, suggesting that physicians are more comfortable with “old” drugs, since their clinical use is supported by established clinical guidelines and protocols. Keywords: opioids sales, community pharmacy, reimbursement policy, legislation changes, breakpoint estimation

© 2018 Elsevier Ltd Full integration of oncology and palliative care relies on the specific knowledge and skills of two modes of care: the tumour-directed approach, the main focus of which is on treating the disease; and the host-directed approach, which focuses on the patient with the disease. This Commission addresses how to combine these two paradigms to achieve the best outcome of patient care. Randomised clinical trials on integration of oncology and palliative care point to health gains: improved survival and symptom control, less anxiety and depression, reduced use of futile chemotherapy at the end of life, improved family satisfaction and quality of life, and improved use of health-care resources. Early delivery of patient-directed care by specialist palliative care teams alongside tumour-directed treatment promotes patient-centred care. Systematic assessment and use of patient-reported outcomes and active patient involvement in the decisions about cancer care result in better symptom control, improved physical and mental health, and better use of health-care resources. The absence of international agreements on the content and standards of the organisation, education, and research of palliative care in oncology are major barriers to successful integration. Other barriers include the common misconception that palliative care is end-of-life care only, stigmatisation of death and dying, and insufficient infrastructure and funding. The absence of established priorities might also hinder integration more widely. This Commission proposes the use of standardised care pathways and multidisciplinary teams to promote integration of oncology and palliative care, and calls for changes at the system level to coordinate the activities of professionals, and for the development and implementation of new and improved education programmes, with the overall goal of improving patient care. Integration raises new research questions, all of which contribute to improved clinical care. When and how should palliative care be delivered? What is the optimal model for integrated care? What is the biological and clinical effect of living with advanced cancer for years after diagnosis? Successful integration must challenge the dualistic perspective of either the tumour or the host, and instead focus on a merged approach that places the patient's perspective at the centre. To succeed, integration must be anchored by management and policy makers at all levels of health care, followed by adequate resource allocation, a willingness to prioritise goals and needs, and sustained enthusiasm to help generate support for better integration. This integrated model must be reflected in international and national cancer plans, and be followed by developments of new care models, education and research programmes, all of which should be adapted to the specific cultural contexts within which they are situated. Patient-centred care should be an integrated part of oncology care independent of patient prognosis and treatment intention. To achieve this goal it must be based on changes in professional cultures and priorities in health care.

Purpose: Cancer pain (CP) management is challenging. In recent years, efforts were undertaken to achieve better CP management, e.g. clinical research, new treatment modalities, development of guidelines, education, and focus on implementation. The aim of the present study was to compare the prevalence and characteristics of pain and breakthrough pain (BTP) between cross-sectional studies conducted in 2008 and 2014. It was hypothesized that an improvement in pain control would be observed the years in-between. Methods: Two cross-sectional studies were conducted where adult cancer patients answered questions from Brief Pain Inventory and the Alberta Breakthrough Pain Assessment Tool for cancer patients. Physicians reported socio-demographic and medical data. Regression models were applied for analysis. Results: In total, 168 inpatients, 92 in 2008 and 76 in 2014, and 675 outpatients, 301 in 2008 and 374 in 2014, were included. The patient characteristics of the samples were comparable. Prevalence of CP among inpatients was 55% in 2008 and 53% in 2014, and among outpatients 39% and 35%, respectively. Inpatients reported average pain intensity (0-10 NRS) of 3.60 (SD 1.84) (2008) and 4.08 (SD 2.11) (2014), prevalence of BTP was 52% (2008) and 41% (2014). For outpatients, average pain intensity was 3.60 (SD 2.04) (2008) and 3.86 (SD 2.20) (2014), prevalence of BTP was 43% (2008) and 37 % (2014). None of the differences were statistically significant. Conclusion: Unexpectedly, no improvement in pain control was observed. Efforts are still needed to improve cancer pain management. © Springer-Verlag Berlin Heidelberg 2015. This is the authors’ accepted and refereed manuscript to the article. The final publication is available at Springer via http://dx.doi.org/10.1007/s00520-015-3064-3

Background More than 60 per cent of patients treated surgically for primary retroperitoneal sarcoma survive for at least 5 years. Extended surgical resection has been proposed for primary disease, but long-term morbidity data are lacking. A cross-sectional study was conducted to assess the long-term morbidity of patients undergoing surgery for retroperitoneal sarcoma. Methods Patients operated on between January 2002 and December 2011 were eligible for the study. Long-term morbidity was evaluated based on a semistructured clinical interview. Lower limb function was assessed by means of the Lower Extremity Functional Scale (LEFS), a self-report questionnaire with a total score ranging from 0 (low functioning) to 80 (high functioning). Pain was investigated by means of the Brief Pain Inventory – Short Form, with pain intensity scores reported on a scale from 0 (no pain) to 10 (worst pain). Results Some 243 patients underwent surgery, and 101 of 160 patients who were alive at the time of the investigation responded to the study invitation letter. Finally, 95 patients were enrolled in the study. Sensory impairment of the limbs was reported in 72 patients (76 per cent). The median LEFS score was 60 (i.q.r. 43–73). Mean scores for the pain intensity items varied from 1·23 to 2·68. In multivariable analysis, there was no difference in median levels of creatinine at survey between patients who did or did not undergo nephrectomy (difference between median values 13 (95 per cent c.i. −4 to 30) µmol/l; P = 0·170). Conclusion Severe chronic pain and lower limb motor impairment after multivisceral resection for retroperitoneal sarcomas are rare. Long-term renal function is not significantly impaired when nephrectomy is performed.

Aims and Background To evaluate postoperative pain (PoP) and quality of life (QoL) in patients undergoing open (O-) or laparoscopic (L-) retroperitoneal lymph node dissection (RPLND) for clinical stage I (CS I) and normal markers CS IIA nonseminomatous germ cell tumors. Methods Since March 2010, a prospective nonrandomized trial evaluated dynamic and rest (R) numeric pain scale (NPS) following patient-controlled analgesia and baseline (T0), 3-month (T3), and 6-month (T6) QoL status assessed by Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire and the Italian-validated Functional Assessment of Chronic Illness Therapy (FACT-T-SG) at T6. Secondary endpoints included length of hospital stay (LHS), interval to recovery (ItR), complications, and oncologic outcomes. Results In March 2012, 69 (64 CS I) patients were enrolled. Five patients only chose O-RPLND. The PoP and complete QoL data are available in 41 and 56 patients, respectively. The R-NPS significantly improved in days 1-2 vs day 0 (pConclusions Almost all patients chose L-RPLND, which is associated with a rapid improvement of postoperative pain; QoL scores improved up to 6 months. The L-RPLND may be considered as an alternative only when performed in highly experienced centers.

Few studies regarding palliative sedation (PS) have been carried out in home care (HC) setting. A comparison of PS rate and practices between hospice (HS) and HC is also lacking.Comparing HC and HS settings for PS rate, patient clinical characteristics before and during PS, decision-making process, and clinical aspects of PS.About 38 HC/HS services in Italy participated in a multicenter observational longitudinal study. Consecutive adult cancer patients followed till death during a four-month period and undergoing PS were eligible. Symptom control and level of consciousness were registered every eight hours to death.About 4276 patients were screened, 2894 followed till death, and 531 (18%) underwent PS. PS rate was 15% in HC and 21% in HS (P 0.001). Principal refractory symptoms were delirium (54%) and dyspnea (45%), respectively, more common in HC (P 0.001) and HS (P = 0.03). Informed consent was not obtained in 72% of patients but achieved by 96% of families. Midazolam was the most used drug (94% HS vs. 75% HC; P 0.001) mainly by continuous infusion (74% HC vs. 89% HS; P 0.001). PS duration was less than 48 hours in 67% of patients. Hydration during PS was less frequent in HC (27% vs. 49%; P 0.001). In the eight hours before death, consciousness level was unrousable to mild physical stimulation in 81% and symptom control complete in 89% of cases.Our results show feasibility of PS in HC and HS and suggest setting differences in rates, indications, and practice of PS, possibly related to patients' selection or care organization.

Purpose Explore clinical factors associated with higher pain intensity and future pain in patients with bone metastases to identify patients who can benefit from closer follow-up or pain-modifying interventions. Methods This is a secondary analysis of 606 patients with bone metastases included in a multicenter longitudinal study. The dependent variables were “average pain” and “worst pain” in the last 24 h (0–10 NRS). Twenty independent variables with potential association to pain intensity were selected based on previous literature. Cross-sectional analyses were performed with multiple linear regression to explore factors associated with pain intensity at baseline. Longitudinal data were analyzed with a generalized equation models to explore current factors associated with pain intensity at the next visit in 1 month. Results Current pain intensity (p

Purpose The semantics of defining cancer cachexia over the last decade has resulted in uncertainty as to the prevalence. This has further hindered the recognition and subsequent treatment of this condition. Following the consensus definition for cancer cachexia in 2011, there is now a need to establish estimates of prevalence. Therefore the primary aim of the present study was to assess the prevalence of cachexia in an unselected cancer population. A secondary aim was to assess patient-perceived need of attention to cachexia. Methods A cross-sectional study in hospital patients was undertaken. Key inclusion criteria were: age >18 years, cancer diagnosis, and no surgery the preceding 24 hours. Data on demographics, disease, performance status, symptoms, cachexia and patients’ perceived need of attention to weight loss and nutrition was registered Results Data were available on 386 of 426 eligible patients. Median age (IQR) was 65 years (56-72), 214(55%) were male and 302(78%) had a performance status of 0-1 (Eastern Cooperative Oncology Group). Prevalence of cachexia (inpatients/outpatients) was 51%/22%. Prevalence was highest in patients with gastrointestinal cancer (62%/42%) and lung cancer (83%/36%). There was no major difference in prevalence between patients with metastatic (55%/24%) and localized disease (47%/19%). 20% of inpatients and 15% of outpatients wanted more attention to weight loss and nutrition. Cachexia (p

Neuropathic pain (NP) in cancer patients lacks standards for diagnosis. This study is aimed at reaching consensus on the application of the International Association for the Study of Pain (IASP) special interest group for neuropathic pain (NeuPSIG) criteria to the diagnosis of NP in cancer patients and on the relevance of patient-reported outcome (PRO) descriptors for the screening of NP in this population. An international group of 42 experts was invited to participate in a consensus process through a modified 2-round Internet-based Delphi survey. Relevant topics investigated were: peculiarities of NP in patients with cancer, IASP NeuPSIG diagnostic criteria adaptation and assessment, and standardized PRO assessment for NP screening. Median consensus scores (MED) and interquartile ranges (IQR) were calculated to measure expert consensus after both rounds. Twenty-nine experts answered, and good agreement was found on the statement "the pathophysiology of NP due to cancer can be different from non-cancer NP" (MED=9, IQR=2). Satisfactory consensus was reached for the first 3 NeuPSIG criteria (pain distribution, history, and sensory findings; MEDs⩾8, IQRs⩽3), but not for the fourth one (diagnostic test/imaging; MED=6, IQR=3). Agreement was also reached on clinical examination by soft brush or pin stimulation (MEDs⩾7 and IQRs⩽3) and on the use of PRO descriptors for NP screening (MED=8, IQR=3). Based on the study results, a clinical algorithm for NP diagnostic criteria in cancer patients with pain was proposed. Clinical research on PRO in the screening phase and on the application of the algorithm will be needed to examine their effectiveness in classifying NP in cancer patients.