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Background Worldwide, cancer pain management follows the World Health Organization (WHO) three-step analgesic ladder. Using weak opioids (e.g. codeine) at step 2 is debatable with low-dose strong opioids being potentially better, particularly in low- and middle-income countries where weak opioids are expensive. We wanted to assess the efficiency, safety and cost of omitting step 2 of the WHO ladder. Patients and methods We carried out an international, open-label, randomised (1 : 1) parallel group trial. Eligible patients had cancer, pain ≥4/10 on a 0-10 numerical rating scale, required at least step 1 (paracetamol) of the WHO ladder and were randomised to the control arm (weak opioid, step 2 of the WHO ladder) or the experimental arm (strong opioid, step 3). Primary outcome was time to stable pain control (3 consecutive days with pain ≤3). Secondary outcomes included distress, opioid-related side-effects and costs. The primary outcome analysis was by intention to treat and the follow-up was for 20 days. Results One hundred and fifty-three patients were randomised (76 control, 77 experimental). There was no statistically significant difference in time to stable pain control between the arms, P = 0.667 (log-rank test). The adjusted hazard ratio for the control arm was 1.03 (95% confidence interval 0.72-1.49). In the control arm, 38 patients (53%) needed to change to a strong opioid due to ineffective analgesia. The median time to change was day 6 (interquartile range 4-11). Compared to the control arm, patients in the experimental arm had less nausea (P = 0.009) and costs were less. Conclusion This trial provides some evidence that the two-step approach is an alternative option for cancer pain management.

Background: We have previously reported that the safety and efficacy of ipilimumab in real-world patients with metastatic melanoma were comparable to clinical trials. Few studies have explored health-related quality of life (HRQL) in real-world populations receiving checkpoint inhibitors. This study reports HRQL in real-world patients receiving ipilimumab and assesses the prognostic value of patient-reported outcome measures. Patients and methods: Ipi4 (NCT02068196) was a prospective, multicentre, interventional phase IV trial. Real-world patients (N = 151) with metastatic melanoma were treated with ipilimumab 3 mg/kg intravenously as labelled. HRQL was assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire at baseline and after 10-12 weeks. Results: The European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire was completed by 93% (141/151 patients) at baseline, and by 82% at 10-12 weeks. Poor performance status and elevated C-reactive protein (CRP) were associated with worse baseline HRQL. Clinically relevant and statistically significant deteriorations in HRQL from baseline to weeks 10-12 were reported (P

Background The European Society for Medical Oncology (ESMO) Designated Centres (DCs) of Integrated Oncology and Palliative Care is an incentive programme established in 2003 aiming to improve the integration of oncology and palliative care services provided by oncologists and oncology centres worldwide. Currently, the ESMO DCs programme has over 250 centres accredited from 54 countries worldwide, in all six world regions. Materials and methods To evaluate how ESMO can support centres to improve programme development, education and research and vice versa what each single centre can do to improve in these areas, we developed a survey which was shared with all active centres. Two hundred and seven ESMO DCs representing 44 countries were invited to participate. We used content analysis to identify response categories using a stepwise approach. After reviewing and coding all responses to each question separately, they were placed into categories, counted and labelled. Results Of the 207 centres that were invited to participate, 146 centres started the survey, representing 43 countries. Five overarching topics were identified. They included (i) joint events and educational activities; (ii) sharing of materials and defining common standards; (iii) sharing of experiences, scientific knowledge and expertise; (iv) research collaboration; and (v) ESMO support. Respondents were willing to support the ESMO DC community group in all topics and were also asking ESMO to support their centres in these issues in the future. Conclusion The study showed that the ESMO DCs are willing to provide support to improve education, research and programme development. They are also eager to contribute and collaborate amongst each other, but also request ESMO to offer advice and help to improve these issues in the DCs. In the future, facilitation of joint research projects and development of arenas to share experiences, educational and programme developments, and other resources are to be explored and could be offered to the DCs worldwide.

Background: Patients with advanced cancer and bone metastases may have unmet palliative care needs that go unnoticed during clinical oncological practice. This observational study describes palliative care needs and interventions identified because of participation in a clinical study. Methods: Patients with advanced cancer and painful bone metastases included in the Palliative Radiotherapy and Inflammation Study (PRAIS) aiming to predict the response of radiotherapy (RT) were eligible. All patients met with the palliative care (PC) study team prior to start of RT, after they had completed patient reported outcome measures (PROMs). Symptoms prompting interventions by the study team were documented in the patient charts and reviewed.Results: One hundred-and thirty-three patients were reviewed; 63% males, mean age 65 and mean Karnofsky score (KPS) 73. Interventions were initiated in 50% (n=67) of the patients. Most common were changed opioid management (69%), treatment of constipation (43%) and nausea (24%) and nutritional advices (21%). Patients receiving interventions had lower mean KPS (70 vs 77 p Conclusions: Adverse symptoms are often not identified in routine oncological consultations prior to RT for cancer pain. Special attention should be directed to frail patients. These findings call for an early and systematic integration of palliative care in patients with advanced cancer.Trial registration: ClinicalTrials.gov NCT02107664

High-quality research in palliative care is a prerequisite for improving the evidence base, and closing the gap between knowledge and practice to improve patient care. Palliative care research is demanding, as it implies a huge diversity of healthcare services at different levels of care, delivered by multiple professions to vastly different populations. The need for evidence-based, efficient, and cost-effective services is evident, given the rapidly ageing population who live longer with serious and complex illnesses. This calls for collaborative research efforts focusing on both patient-centred and disease-centred outcomes during the disease trajectories and care pathways. This chapter discusses a range of topics focusing on why and how to conduct research in palliative care, and provides information on how to start, proceed, and complete sound research projects, as effectively and targeted as possible. Topics include, among others, challenges in palliative care research, research governance and ethical considerations, controlled clinical trials, and trial planning (including designs, methodology, collaboration, randomization, protocol development, statistical considerations, study conduct, including defining and including patients, randomization, and publication).

To improve or sustain patients’ quality of life (QoL) is the main goal of palliative care. In palliative care as in healthcare in general, QoL is commonly conceptualized as health-related quality of life (HRQoL) which is the self-perceived health status of an individual and encompasses measurable components that are related to health, disease, illness, and medical interventions. Patient-reported outcome (PRO) measures is the term presently used for any measure that collects responses directly from the patients and includes measures on QoL, HRQoL, functions, and symptoms. In spite of substantial evidence on the positive outcomes of using PRO instruments (questionnaires) in the clinic, such use still faces barriers from the health system and the healthcare providers. The content and the measurement capabilities of present PRO instruments can also be a barrier. The selection of PRO instruments is recommended to follow a sequential approach. Define overall aim(s), define the research question(s), agree upon the key outcome(s), and select the appropriate set of questions/questionnaires guided by the primary and secondary outcomes. In general, it is recommended to use a generic or a disease-specific questionnaire and supplement with domain-specific questionnaire(s) for measurement of fatigue, pain, anxiety, depression, or other symptoms/functions reflecting the purpose(s) of the data collection.

Title: To Give One’s Money Willingly. Children as Consumers in Ungdommens Ven (1770) This article examines the staging of children as consumers in the first Danish children’s magazine Ungdommens Ven (1770). By investigating texts that portray children and their use of pocket money, with an emphasis on texts in which this use is directly linked to the purchasing of the magazine itself, the article argues that the staging of children as consumers may be seen in the context of children’s increasingly important role in the book market and print culture during the second half of the 18 th century. Through a discussion of how children appear as readers, consumers, and subscribers in the magazine, the article demonstrates how Ungdommens Ven is educative in at least two interwoven ways. First, by instructing the readers in how to spend one’s money wisely, and second, by inculcating the knowledge of how to be magazine readers as well as purchasers, initiating children into the economic aspects of the specific publication and into consumer culture more generally. Taking one of the early children’s magazines in Denmark as its point of departure, the article identifies some significant changes in print and consumer culture before the emergence of a mass market, accentuating the role of children and their magazines in these developments.

Physical exercise as an intervention in cancer patients has attracted increasing interest. This review examines the published randomised controlled trials on physical exercise, during and after cancer treatment, focusing primarily on recruitment of patients, patient compliance, content of the intervention programmes and outcome measures. We performed systematic searches of PubMed, PsychInfo, Cancerlit and the Cochrane Library using the MESH terms exercise, neoplasms, cancer, rehabilitation and intervention. We identified 12 randomised trials with sample sizes ranging from 21 to 155 patients. Only four studies reported the number of patients assessed for eligibility and the reasons for exclusion; 15% to 30% of patients assessed for eligibility were randomised into the intervention programmes. Drop-out rates in the trials ranged from 0% to 34%. Most studies included female breast cancer patients (nine studies, 62% of total number of patients). Interventions included aerobic exercise training (10 studies) and resistance exercise (two studies). The studies used a wide range of instruments to assess health-related quality of life (HRQOL) and the physical exercise capacity. The studies indicated promising effects on both physiological and psychological outcomes. Randomised clinical studies are few, small in scope, and mainly focus on breast cancer patients. Complete knowledge about the type of physical exercise most beneficial for patients at different stages of the disease progression is still lacking. Future work should identify fewer and more specific endpoints.

Purpose To investigate whether the effect of hypofractionated thoracic radiotherapy (TRT) is comparable to more standard fractionated radiotherapy (RT) in advanced non–small-cell lung cancer (NSCLC). Patients and Methods A total of 421 patients with locally advanced stage III or stage IV NSCLC tumors were included. Inclusion criteria were inoperable, disease too advanced for curative radiotherapy, and chest symptoms or central tumor threatening the airways. Patients were randomly assigned to three arms: A, 17 Gy per two fractions (n = 146); B, 42 Gy per 15 fractions (n = 145); and C, 50 Gy per 25 fractions (n = 130). Four hundred seven patients were eligible for the study; 395 patients (97%) participated in the health-related quality-of-life (HRQOL) study. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-lung cancer–specific module (LC13) were used to investigate airway symptom relief and changes in HRQOL. Assessments were performed before TRT and until week 54. Clinicians' assessments of symptom improvement were at 2, 6, and 14 weeks after completion of TRT. The patients were observed for a minimum of 3 years. Results Baseline prognostic data were equally distributed in the treatment groups. Patient compliance with respect to the HRQOL investigation was minimum 74%. HRQOL and symptom relief were equivalent in the treatment arms. No significant difference in survival among arms A, B, and C was found, with median survival 8.2, 7.0, and 6.8 months, respectively. Conclusion Our data indicate that protracted palliative TRT renders no improvement in symptom relief, HRQOL, or survival when compared with short-term hypofractionated treatment in advanced NSCLC.

This study examines the association between alternative medicines (AM) and cancer survival. A national multicentre study was carried out in Norway in December 1992 to assess the prevalence of AM use among cancer patients. One of the aims of this study was to assess the association between AM and long-time survival. In January 2001, survival data were obtained with a follow-up of 8 years for 515 cancer patients. A total of 112 (22%) assessable patients used AM. During the follow-up period, 350 patients died. Death rates were higher in AM users (79%) than in those who did not use AM (65%). In a Cox regression model adjusted for demographic, disease and treatment factors, the hazard ratio of death for any use of AM compared with no use was 1.30, (95% Confidence Interval (CI) 0.99, 1.70; P=0.056), suggesting that AM use may predict a shorter survival. Sensitivity analyses strengthened the negative association between AM use and survival. AM use had the most detrimental effect in patients with an ECOG (Eastern Cooperative Oncology Group) performance status (PS) of 0 (hazard ratio for use=2.32, 95% CI, 1.44, 3.74, P=0.001), when compared with an ECOG PS of 1 or higher. The use of AM seems to predict a shorter survival from cancer. The effect appears predominantly in patients with a good PS.

This study tests the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and version 3.0 of the EORTC Core Questionnaire (QLQ-C30) in 622 head and neck cancer patients from 12 countries. The patients completed the QLQ-C30, the QLQ-H&N35 and a debriefing questionnaire before antineoplastic treatment or at a follow-up. 232 patients receiving treatment completed a second questionnaire after treatment. Compliance was high and the questionnaire was well accepted by the patients. Multitrait scaling analysis confirmed the proposed scale structure of the QLQ-H&N35. The QLQ-H&N35 was responsive to differences between disease status, site and patients with different Karnofsky performance status, and to changes over time. The new physical functioning scale (with a four-point response format) of version 3.0 of the QLQ-C30 was shown to be more reliable than previous versions. Thus, the QLQ-H&N35, in conjunction with the QLQ-C30, appears to be reliable, valid and applicable to broad multicultural samples of head and neck cancer patients.

Interpretation of health related quality of life (HRQOL) results in cancer patients is facilitated by knowledge of the levels of HRQOL in the general population. However, direct comparisons can be misleading unless age and gender are considered. We demonstrate the derivation of age- and gender-specific 'expected' values from population reference values by means of simple calculations. This survey included 3000 randomly selected Norwegians above 18 years of age who received the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 (+3) by mail. 1965 responses from 2,892 eligible persons (68%) were received. The population was divided into six disease groups based on self-reported health problems. The observed mean scale scores of the different groups deviated greatly from those obtained in the general population. The score for physical function, for example, was 72 for cancer patients and ranged from 73.3 to 82.5 in other disease groups, as opposed to 89.9 in the general population and 98.9 in those with no health problems. The range for one of the quality of life (QOL) scales was 57.7 to 84.7 compared with 73.7 in the general population. Expected mean scores for the patient groups were computed from the reference values, based on the concept of equivalence of age and gender. The differences between the observed mean scores and the reference values were strongly mediated by this method. The expected scores for physical function then ranged from 83.3 to 93.1 and from 70.3 to 75 for the QOL scale. The impact of age and gender on the reference data from the EORTC QLQ-C30 (+3) obtained in a general population shows that these variables must be considered when interpreting data on HRQOL for cancer patients. The demonstration of how to generate mean values which are adjusted according to the age and gender distribution of a population should increase the usefulness of this questionnaire among clinicians.

PURPOSE To investigate the prospective pattern of use of alternative medicine, here called nonproven therapy (NPT), among oncologic patients during a 5-year period, and the relationship between this use and survival, a questionnaire-based follow-up study was performed at the Department of Oncology, University of Tromsø, from 1990 to 1996. PATIENTS AND METHODS Two-hundred fifty-two patients answered the first questionnaire during the period July 1990 to July 1991. Eligible patients were mailed follow-up questionnaires after 4, 12, 24 and 60 months. A telephone interview performed after the last follow-up questionnaire showed little disagreement with the prospective collected information as regards the number of patients reported as users of NPT (kappa, 0.92). RESULTS The number of patients who reported ever using NPT in each cross-sectional part of the study varied between 17.4% and 27.3%. However, the estimated cumulative risk of being a user of NPT during the follow-up period was 45%. Seventy-four percent of NPT users in this north Norwegian study population used faith healing or healing by hand (spiritual NPT) alone or in combination with other forms of NPT. The proportion of patients who used spiritual versus nonspiritual forms of NPT was consistent throughout the follow-up period. Women were more often users than men (50% v 31%, P = .002). Patients older than 75 years of age seldomly used NPT. The 5-year observed survival rate was not influenced by the use of NPT. Adjusted for sex, age, and diagnosis, patients with a high educational level had a borderline higher 5-year survival rate than patients with less education (P = .06). CONCLUSION Our results demonstrate that cross-sectionally designed studies will underestimate the number of ever-users of NPT in a cancer patient population. The use of NPT does not influence observed survival among cancer patients seen in north Norway.

A questionnaire-based study was carried out at the Department of Oncology, University Hospital of Tromsø, during the period July 1990-October 1991. The 252 participating patients received a questionnaire at arrival at the oncology unit and the surviving patients a follow-up questionnaire at home 4 months later. The aim of the study was to assess whether patients' attitudes to information about their malignant disease and satisfaction with the given treatment correlated to their use of non-proven therapies (NPTs) and reported mental distress. Patients under 45 years of age significantly more often preferred comprehensive medical information than older patients (83% versus 52%, P = 0.001). Better educated patients were more satisfied with the information given by their general practitioner (GP) (P = 0.05) and at their local hospital (P = 0.02) than other patients. Of all responders, 81% of the patients treated in the department were completely satisfied with the opportunities to ask questions while 87% reported being given comprehensive information. Only 2% of the patients reported to have received unwanted information. Better educated patients expressed less satisfaction with the information given and the possibility of influencing their own treatment at the Department of Oncology (P = 0.02). Patients expressing mental distress wanted less information (P = 0.05) and expressed less satisfaction with the quality of the perceived information in the oncology unit (P = 0.004). They were also less satisfied with the treatment given (P = 0.05) and their own influence on the treatment decision (P = 0.02). Users of NPT did not feel the received treatment to be the best possible (P = 0.04).

This study addressed the use of alternative medicine, here called non-proven therapies (NPTs), among hospitalized Norwegian cancer patients. A total of 126 (20%) of the assessable 630 patients were users of NPTs. Approximately 43% of all patients and more than 60% of the users of NPTs stated that they would like NPTs to be an option in hospitals belonging to the National Health Service. Most users of NPTs (82%) consulted traditional medicine first, while 15% started treatment with NPTs simultaneously. Users of NPTs reported to have received less hope of a cure (30%) from their physicians than non-users (50%). Users mostly learned about NPTs from friends and relatives. Most users believed that NPTs might give them strength and relieve their symptoms. Very few patients believed in a cure (10%). Nearly 40% were uncertain of any effect of the NPTs or felt there had been no effect. 4 patients reported adverse effects. 15 patients had been treated abroad, most of them in Denmark. Expenses incurred through use of NPTs were mostly moderate, but some patients used large sums of money. Patients' opinions on whether or not the treatment had been expensive were closely linked to their anticipation of the effect of the treatment.

Background: Slow release (SR) opioids around the clock are the mainstay for moderate to strong cancer pain. This recommendation is not scientifically based. Therefore, a phase 1 pilot study of rapid acting nasal fentanyl (NF) taken on demand as the only opioid for cancer pain to explore feasibility and safety aspects was launched. Methods: Patients with cancer, naive to strong opioids but in need of such drugs, were included. They received a test dose of NF before titration (1-5 days) was started. Ten days treatment was followed by 7 days of observation after switching to SR morphine. Pain relief, nausea, sedation, and local irritation were assessed (11-point numeric rating scale [NRS]). Other adverse events (AEs) were also recorded by the patient. Investigator had regular patient telephone contact. Results: Ten patients were included. The test dose was well tolerated. Venous fentanyl concentrations at 11 minutes after the test dose differed considerably. All subjects completed the titration; six patients the treatment phase. Three serious AEs were reported; all due to hospitalization, none related to NF. A possible adverse drug reaction (hearing abnormalities) was reported. Other adverse effects were minor. NF treatment reduced average pain for the whole group compared to baseline (4.6-3.7 on the 11-point NRS) and pain relief was achieved in 187/230 (81 percent) of NF administrations (reduction of 2 or more on the 11-piont NRS 15 minutes after NF administration). Conclusion: This explorative study suggests that it is reasonable that the concept of treating pain in patients with cancer using NF on demand can undergo controlled clinical studies.

Dealing with cancer pain implies assessing the intensity and other attributes of pain and identifying appropriate outcomes and endpoints to evaluate the effect of treatments.In the context of an observational longitudinal prospective study, 1461 painful cancer patients were evaluated at baseline and weekly over 4 weeks. Four pain intensity (PI) measures (worst, average, least and right now: WP, AP, LP, and PRN), pain relief and patients' satisfaction with pain treatments were recorded. Starting from these data, we extrapolated the full responder (FR) subjects, whose PI decreased by ≥2 points, or by ≥30%, or who obtained a final score of ≤5 points, according to criteria previously suggested by literature. The receiver operating characteristics (ROC) curve analysis was used to estimate the predictive accuracy.All the PI measures decreased from the initial to final visit: the reduction was 1.9 as WP, 1.3, 0.8 and 1.2 as AP, LP and PRN, respectively. The proportion of FR differed from 47.8% to 88.3% depending on PI measures and the criterion adopted. ROC analysis showed an acceptable accuracy of all endpoints and confirmed the cut-offs recommended by the literature. The best criterion corresponded to a PI absolute value of ≤4 points when measured as AP.All measures applied seem able to profile the evolution of pain, with some differences. This implies the need of an appropriate choice of outcomes and endpoints according to the goal and objective of the intervention under evaluation.

Recently, low-dose transdermal buprenorphine (LD-TD-BUP) was introduced for treatment of patients with chronic non-malignant pain. The primary aim of this study was to determine the proportion of patients who were prescribed LD-TD-BUP for non-malignant pain who became long-term users. The secondary aim was to determine the proportion of patients who co-medicated with other opioids or benzodiazepines during treatment with LD-TD-BUP.Data were drawn from the Norwegian Prescription Database that covers all prescriptions dispensed at pharmacies to the entire Norwegian population (4.7 million inhabitants). The study population consisted of all patients who were dispensed at least one prescription of LD-TD-BUP from its introduction in November 2005 to 31 December 2008. Patients who were dispensed more than 24 patches (≥ 6 months) were defined as long-term users. Reimbursement codes were used to stratify patients as having cancer pain or non-malignant pain.Among new users of LD-TD-BUP for non-malignant pain (n = 13,451), only 22% became long-term users, while 44% were only dispensed one prescription. Among long-term users who were opioid naive when LD-TD-BUP was initiated, 43% co-medicated with other opioids or benzodiazepines, compared with 82% of those who previously had used opioids.Three years after introduction, 0.4% of the Norwegian population had been dispensed LD-TD-BUP. Only one-fifth had become long-term users. Those who used opioids before the first dispension of LD-TD-BUP co-medicated with other potentially addictive drugs to a much higher degree compared with those who were opioid naive.

This topical review addresses methadone's pharmacology, its application in malignant and non-malignant pain conditions, practical issues related to methadone for the treatment of pain and its influence on QTc time.Relevant papers were identified in PubMed and EMBASE.Methadone is advocated by experts as a second line opioid when first line opioids fail to provide a satisfactory balance between pain control and side effects (opioid switching). Although randomized-controlled studies are lacking, current evidence suggests that switching to methadone in this situation reduces pain intensity. However, interindividual variability in its pharmacokinetics make its application challenging and metabolism by CYP 3A4 and 2B6 implies a substantial risk of drug-drug interactions. Several ways of switching to methadone have been presented, with a gradual switch during 3 days or 'stop and go' as the dominating strategies. Episodes of torsade de pointes arrhythmia during methadone treatment have been reported in patients with other risk factors for arrhythmia, while small prospective studies have reported a small, lasting and stable increase in QTc time. The extensive use of methadone for opioid replacement in addicts has added additional patient barriers to its use for pain control.In spite of challenges related to the variable pharmacokinetics and concerns regarding increase in QTc time, current evidence indicates that opioid switching to methadone improves pain control in a substantial proportion of patients who are candidates for opioid switching. Measures must be instituted to secure that patients receiving methadone for pain are not considered opioid addicts.

In order to evaluate long-term somatic morbidity after treatment for testicular cancer 149 patients with NED greater than or equal to 3 years answered a questionnaire. The patients had been treated with surgery only (32 patients, radiotherapy only (39 patients), cisplatin-based chemotherapy plus surgery (46 patients) or chemotherapy plus radiotherapy with or without surgery (32 patients). Raynaud-like phenomena were the most frequent side-effect occurring significantly more often after cisplatin-based chemotherapy than after surgery or radiotherapy (33/72 patients versus 5/68 patients). Peripheral sensory 'neuropathy' was reported by 18% of all the patients. Seventeen per cent and 11% complained of pulmonary symptoms and auditory symptoms, respectively. Gastrointestinal side-effects were more frequent after any type of cytotoxic therapy than after surgery only (34/47 patients versus 5/22 patients). Twenty-six patients had fathered children after treatment. About 80% of the patients were in full time wage-earning activity when they answered the questionnaire. In conclusion, 3-7 years after treatment for testicular cancer, 30-50% of the patients had minor somatic complaints whereas serious side-effects seldom occurred.

Patients with chronic non-malignant pain (CNMP) conditions are known to report reduced health-related quality of life (HRQoL). The objective of this exploratory study was to compare HRQoL between patients admitted to a multidisciplinary pain centre, palliative cancer (PC) patients and national norms.HRQoL data from 288 patients with CNMP admitted to the multidisciplinary pain centre at Trondheim University Hospital were compared with 434 patients with advanced cancer included in a trial of comprehensive palliative care in the hospital palliative medicine unit and national norms. HRQoL was assessed using the EORTC QLQ-C30. Age- and gender-adjusted norm data were calculated and compared between the two groups.Scores from both groups deviated from adjusted norm data on all scales, with poorer functioning and more symptoms. Compared with PC patients, CNMP patients reported a larger deviation (worse scores) on global quality of life, cognitive functioning, pain, sleep disturbances and financial difficulties. Deviations from norm data were similar for physical, social and emotional functioning, diarrhoea, dyspnoea and fatigue. PC patients reported worse scores on role functioning, nausea/vomiting, loss of appetite and constipation.CNMP patients admitted to multidisciplinary pain centres report significantly reduced HRQoL, in addition to severe pain. They consider their HRQoL to be as poor as HRQoL reported from dying cancer patients and substantially poorer than national norms. Factors other than the biological severity of the disease seem to be of major importance for self-reported HRQoL.

Der neuropathische Schmerz bei onkologischen Patienten erfordert eine spezielle analgetische Therapie. Deshalb ist eine korrekte Diagnose entscheidend – allerdings fehlt es hier an standardisierten Methoden. Cinzia Brunelli und Kollegen pruften nun, ob Experten sich ubereinstimmend zu 2 wichtigen Diagnose-Tools ausern wurden: zum einen zu den Kriterien der Fachgruppe fur neuropathischen Schmerz der International Association for the Study of Pain (IASP NeuPSIG-Kriterien), zum anderen zu Parametern, die die Patienten in der Anamnese berichten (patient-reported outcome descriptors, PRO).

In order to make treatment decisions physicians should have knowledge about the relations between patient characteristics and drug disposition. Dose, route of administration, gender, age and renal function are reported to influence the serum concentrations of morphine, morphine-6-glucurnide (M6G) and morphine-3-glucuronide (M3G) during chronic treatment of cancer pain. These factors, however, are not evaluated in studies with a sample size sufficient to explore predictive factors.Three hundred consecutive morphine users admitted because of a malignant disease were recruited. The relations of serum concentrations of morphine, M6G and M3G to patient characteristics (gender, age, weight, renal function, liver function, dose, route of administration) were explored, and regression analysis performed to investigate whether these characteristics predicted serum concentrations obtained during routine clinical drug monitoring.Morphine dose was associated with serum concentrations of morphine (r = 0.69), M6G (r = 0.76) and M3G (r = 0.76). Oral morphine resulted in higher dose-adjusted M6G and M3G serum concentrations compared with s.c. morphine. Creatinine serum concentrations correlated with serum concentrations of M6G and M3G. Dose and route of administration predicted morphine serum concentrations, while dose and renal function predicted M6G and M3G serum concentrations. Age was an additional factor predicting M3G concentrations. Dose was the only factor that explained a clinically significant part of the observed variability.Patient characteristics predict only minor parts of the variability of morphine, M3G and M6G serum concentrations observed during routine clinical drug-monitoring in cancer patients.

This study was conducted to explore treatment and disease-related effects on health-related quality of life (HRQoL) in patients with aggressive lymphoma, to identify predictors for impaired long-term HRQoL, and to analyze the prognostic value of pretreatment HRQoL. Ninety-five patients with aggressive lymphoma, constituting a subset of a randomized multicenter trial comparing CHOP and MACOP-B, entered a HRQoL study, using the EORTC QLQ-C30 questionnaire. Patient scores were compared to scores from an age- and gender-adjusted reference population sample, and evaluation of the prognostic value of pretreatment QoL scores in relation to clinical prognostic factors was performed. Before treatment, patients exhibited lower scores of global QoL, physical, role, and social functions, and more appetite loss, compared to the reference population. Role functioning improved compared to baseline, but remained depressed compared to the reference group more than 8 mo after end of treatment. By then, the patient group displayed no difference in other HRQoL variables compared to that of the reference population. No reliable predictor for impaired long-term HRQoL could be identified. In multivariate analysis, including the factors of the International Prognostic Index, pretreatment global QoL was an independent prognostic marker for overall survival. In conclusion, in this population with aggressive lymphoma and favorable prognostic features, HRQoL was not substantially affected during the first year after diagnosis. Pretreatment global QoL may constitute a significant prognostic factor, meriting further investigation in prospective studies.

In May 2000, the Norwegian Medical Association appointed a working group to propose guidelines for the practice of palliative sedation to dying patients (terminal sedation). The present study is part of this work. The aim of the study was to register to what extent this form of palliation is used in Norwegian hospitals, on what indications, how decisions are reached, and whether the treatment is considered necessary. The definition of palliative sedation given was: induction and maintenance of sleep for the relief of pain or other types of suffering in a patient close to death. The intention is exclusively to relieve intractable pain, not to shorten the patient's life.An anonymous questionnaire was sent to 364 Norwegian hospital departments that might have experience with palliative sedation. Results are reported partly as free text comments and partly as frequencies of predetermined response alternatives.58% of the questionnaires were returned. 22% of the respondents had given palliative sedation to a dying patient during the last 12 months, and more than half of the physicians found this intervention sometimes necessary. Pain was the most frequent indication; none of the respondents claimed to haven given sedation exclusively based on depression/anxiety. Lack of resources still seems to be an obstacle to optimal palliative care in Norway.Though it has some methodological weaknesses, this study confirms the need for national guidelines.

The aims of the study are to describe the prevalence of psychiatric disorders in palliative care and how to diagnose these disorders.Literature search including cancer patients, palliative care, psychiatric conditions and diagnostics.Neuropsychiatric conditions such as delirium, dementia and amnestic disorder are prevalent (20%), especially in the terminal phase. Anxiety and depressive symptoms are also common and may be caused by the patients' medical condition. Probably less than 10% have anxiety or depressive disorders. However, methodological limitations make comparisons across studies difficult. The interview is the main basis for assessment of mental status. Doctor-centered interviewing techniques are needed in the assessment of neuropsychiatric disorders. Emotional symptoms are best explored by open-ended questions and facilitating techniques. Psychiatric somatic symptoms such as weight loss, fatigue or insomnia are not valid diagnostic criteria. Selfreport questionnaires and short-form screening instruments are best suited for monitoring the course of the disorders, but must be adapted for this specific population.Neuropsychiatric conditions are the most prevalent psychiatric disorders in palliative care. Good interviewing skills are the main element in the diagnostic workup.

This study tests the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-HN35) and version 3.0 of the EORTC Core Questionnaire (QLQ-C30) in 622 head and neck cancer patients from 12 countries. The patients completed the QLQ-C30, the QLQ-HN35 and a debriefing questionnaire before antineoplastic treatment or at a follow-up. 232 patients receiving treatment completed a second questionnaire after treatment. Compliance was high and the questionnaire was well accepted by the patients. Multitrait scaling analysis confirmed the proposed scale structure of the QLQ-HN35. The QLQ-HN35 was responsive to differences between disease status, site and patients with different Karnofsky performance status, and to changes over time. The new physical functioning scale (with a four-point response format) of version 3.0 of the QLQ-C30 was shown to be more reliable than previous versions. Thus, the QLQ-HN35, in conjunction with the QLQ-C30, appears to be reliable, valid and applicable to broad multicultural samples of head and neck cancer patients.

In order to be able to discuss the issue of whether or not terminal sedation is, or may be conceived of as, a form of help in dying, one needs to be very clear as to the meaning of the terms "help in dying" and "terminal sedation". In this article, we suggest what we take to be detailed and precise definitions of the two forms of voluntary help in dying--euthanasia and physician-assisted suicide. Our definitions (interpretations) basically draw on the Dutch experience and understanding. The Dutch approach implies that acts of abstention, i.e., withholding and withdrawing treatment, and pain and symptom treatment with possible life-shortening effect, including terminal sedation, are to be considered "normal medical practice". Furthermore, death is seen by almost all parties as having natural causes in all of these acts. We also suggest that "palliative sedation" should substitute the expression "terminal sedation". Furthermore, we discuss on what grounds this treatment strategy may be induced, including a presentation of criteria and guidelines that must be met; the issue of documentation of the strategy; palliative sedation in the light of the ethical principle of double effect; and in what way euthanasia could be concealed as palliative sedation. In closing, we comment briefly on the phenomenon of large differences between published cohorts with regard to the frequency of use of palliative sedation. This treatment strategy is open to be challenged both clinically and ethically, and all parties would benefit from a continuous debate over the legitimacy of, and the clinical need for, palliative sedation.

Considerable dose variations and frequent initial side effects have been postulated during start of morphine treatment to patients with pain caused by malignant disease. However, to our knowledge, only one previous study has reported effective doses in morphine naive cancer patients and no prospective evaluation has compared symptoms before with symptoms during morphine titration.We recruited 40 cancer patients with uncontrolled pain despite receiving codeine or dextropropoxyphen. Baseline data were obtained for two days before start of morphine titration using a fixed scheduled escalation of immediate-release (IR) morphine. When a stable morphine dose was achieved, IR morphine was replaced with slow-release (SR) morphine in equivalent doses. Intensity of pain and side effects were assessed daily. The daily consumption of morphine, rescue analgesics and rescue antiemetics were registered.The mean titration time to achieve adequate analgesia was 2.3 days (range: 1-6) using a mean daily morphine dose of 97 mg (range: 60-180). Nausea was unaltered after start with morphine but an increased incidence of vomiting occurred (premorphine period 5%, IR morphine period 29%). Transient sedation delayed dose increment in 9 of the 40 patients but mean sedation scores were unaltered. Constipation scores increased while other side effect scores were unaltered. Eighty-two percent of the patients were satisfied or very satisfied with the pain treatment during introduction of morphine.In cancer patients with uncontrolled pain on weak opioids, successful titration of morphine is achieved fast, with a three-fold morphine dose variation and with little increase in side effects.

Cancer patients with spinal cord compression may develop irreversible neurological deficit. The clinical picture implies back pain and subsequent neurological deficit. There is always a danger of rapid deterioration of the patient's condition. If spinal cord compression is suspected, the case is an emergency. MRI should be preferred in the diagnostic work-up, and corticosteroids be administered promptly. Radiation therapy or surgical treatment should be started as soon as possible. Patient outcome is related to the degree of neurological deficit at the start of treatment.

Fatigue describes reduced capacity to sustain force or power output, reduced capacity to perform multiple tasks over time and simply a subjective experience of feeling exhausted, tired, weak or having lack of energy. Pain and fatigue have several components in common, such as being subjective, prevalent in most patients with cancer and caused by multiple factors of both a physical and psychological nature. In order to explore the relationship between fatigue and pain, data from five studies were used: two random samples from the Norwegian population (n=2323 and n=1965), Hodgkin's disease survivors (n=459), palliative care patients (n=434) and patients with bone metastases (n=94). All patients had completed one or more of the following instruments: EORTC QLQ-C30, SF-36 and/or Fatigue Questionnaire. The level of fatigue was much higher in the two palliative care populations (54.4 and 63.2) as compared to the normal population samples (25.0). Patients with bone metastases had significantly more pain (72.0) than the patients in the palliative care trial (47.4) and norms (20.5). In the two palliative care and bone metastases populations fatigue was almost unchanged over time, while pain was reduced. In the palliative care population a high level of fatigue (80.3) and pain (57.8) was reported 0-1 month before death. The relationship between pain, fatigue and the health-related quality of life domains should be explored in more detail, especially in follow-up studies in order to assess possible changes over time. In addition, the validity of the existing instruments measuring fatigue should be investigated for use in patients with advanced disease and short life expectancy.

Evidence suggest that waiting for hospital treatment leeds to unnecessary sick leaves. However, we know little about the extent of the problem. During a six-week period, 1,061 patients attending a total of ten hospital departments for the first time for outpatient treatment or examination received a self-administered questionnaire about sick leaves during the waiting period. 901 patients responded. Great variations were found between the ten departments. The average waiting period was 86 days (32-226 days). 26% (8-61%) of the patients had had a sick leave during the waiting period caused by the disease for which they were seeking treatment; average duration was 48 days (17-89 days); total sick leave for all patients responding in this survey was 11,000 days. Of patients with a sick leave during the waiting period, 44% thought that the examination or treatment which they attended would increase their ability to work, while their doctors were somewhat less optimistic (36%). The study shows that a large proportion of patients on waiting lists for hospital treatment are incapable of work and that cost savings achieved by cutting down waiting period may be considerable.

Dehydration is frequently encountered in patients with advanced cancer. Recently there has been increasing interest in the use of hypodermoclysis (HDC) for parenteral fluid replacement. There are numerous advantages over the intravenous route of administration, and the method is safe, simple and if administered at home, reduces the number of hospitalisations due to dehydration. In this pilot study, we investigated the value of the procedure, related to patient experience and its feasibility in general. Nine patients were included, with 17 subcutaneous infusions given. No serious side effects were observed. Three patients developed transient localised oedema at the site of infusion, and two of these had no influence on the further administration. Mean duration of the infusions were 8.2 hours. Patient interviews following the completed infusions showed that seven of the eight patients in the study would appreciate the use of this method at home or on the ward if fluid replacement were required. More experience and field trials would be of great value in order to explore the benefits of this method in palliative care.