Norwegian general population normative data for the European Organization for Research and Treatment of Cancer questionnaires: the Quality of Life Questionnaire-Core 30, the Sexual Health Questionnaire QLQ-SHQ22 and the sexual domains of the QLQ-BR23/BR45.

OBJECTIVE: The aim of this study was to provide sex-, age-, and morbidity-specific Norwegian general population normative values for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires QLQ-C30, the sexual health questionnaire QLQ-SHQ22 and the sexual domains of the breast modules QLQ-BR23 and QLQ-BR45. METHODS: A random nationwide sample stratified by sex and age groups (18-29, 30-39, 40-49, 50-59, 60-69 and ≥70 years) was drawn from the Norwegian National Population Register. Participants were notified through national online health services (HelseNorge) and postal mail. The survey included sociodemographic background information, health-related quality of life assessed by the EORTC questionnaires, and morbidity assessed by the Self-Administered Comorbidity Questionnaire. Multivariable linear regression was carried out to estimate the associations of age, sex and morbidity with the EORTC scale and item scores. RESULTS: Of the 15,627 eligible individuals, 5135 (33%) responded. Women and persons with morbidities reported lower functioning and higher symptom burden than men and persons without morbidities, respectively, on nearly all EORTC scales. Sex differences were most prominent for emotional functioning, pain, fatigue and insomnia (QLQ-C30), body image, sexual functioning (QLQ-BR23/45), importance of sexual activity, libido and fatigue (QLQ-SHQ22). The score differences between persons with and without morbidity were highly significant and largest in the youngest and middle-aged groups. CONCLUSION: This is the first study to provide normative values for the EORTC sexual health questionnaire QLQ-SHQ22 and the sexual subscales of the QLQ-BR23 and QLQ-BR45 for all, separately in age groups by sex and morbidity.

Which factors can aid clinicians to identify a risk of pain during the following month in patients with bone metastases? A longitudinal analyses.

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 < 0.001), sleep disturbances (p 0.01 and 0.006), drowsiness (p 0.003 and 0.033) and male gender (p 0.045 and 0.001) were associated with higher average and worst pain intensity in 1 month. In addition, breakthrough pain was related to higher worst pain intensity (p 0.003) in 1 month. The same variables were also associated with higher average pain intensity at baseline. CONCLUSION: Higher current pain intensity, sleep disturbances, drowsiness, male gender, and breakthrough pain are factors associated with higher pain intensity in patients with bone metastases at the next follow-up in 1 month. These factors should be assessed in clinical practice and may aid clinicians in identifying patients that can benefit from closer follow-up or interventions to prevent lack of future pain control. TRIAL REGISTRATION IN CLINICALTRIALS.GOV : NCT01362816.

Characteristics of the case mix, organisation and delivery in cancer palliative care: a challenge for good-quality research.

OBJECTIVES: Palliative care (PC) services and patients differ across countries. Data on PC delivery paired with medical and self-reported data are seldom reported. Aims were to describe (1) PC organisation and services in participating centres and (2) characteristics of patients in PC programmes. METHODS: This was an international prospective multicentre study with a single web-based survey on PC organisation, services and academics and patients' self-reported symptoms collected at baseline and monthly thereafter, with concurrent registrations of medical data by healthcare providers. Participants were patients ≥18 enrolled in a PC programme. RESULTS: 30 centres in 12 countries participated; 24 hospitals, 4 hospices, 1 nursing home, 1 home-care service. 22 centres (73%) had PC in-house teams and inpatient and outpatient services. 20 centres (67%) had integral chemotherapy/radiotherapy services, and most (28/30) had access to general medical or oncology inpatient units. Physicians or nurses were present 24 hours/7 days in 50% and 60% of centres, respectively. 50 centres (50%) had professorships, and 12 centres (40%) had full-time/part-time research staff. Data were available on 1698 patients: 50% females; median age 66 (range 21-97); median Karnofsky score 70 (10-100); 1409 patients (83%) had metastatic/disseminated disease; tiredness and pain in the past 24 hours were most prominent. During follow-up, 1060 patients (62%) died; 450 (44%) <3 months from inclusion and 701 (68%) within 6 months. ANOVA and χ2 tests showed that hospice/nursing home patients were significantly older, had poorer performance status and had shorter survival compared with hospital-patients (p<.0.001). CONCLUSIONS: There is a wide variation in PC services and patients across Europe. Detailed characterisation is the first step in improving PC services and research. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01362816.

Neuropathic pain in cancer: systematic review, performance of screening tools and analysis of symptom profiles.

BACKGROUND: The objectives of this study were to evaluate the methodological quality of rigorous neuropathic pain assessment tools in applicable clinical studies, and determine the performance of screening tools for identifying neuropathic pain in patients with cancer. METHODS: Systematic literature search identified studies reporting use of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), Douleur Neuropathique en 4 (DN4) or painDETECT (PDQ) in cancer patients with a clinical diagnosis of neuropathic or not neuropathic pain. Individual patient data were requested to examine descriptor item profiles. RESULTS: Six studies recruited a total of 2301 cancer patients of which 1564 (68%) reported pain. Overall accuracy of screening tools ranged from 73 to 94%. There was variation in description and rigour of clinical assessment, particularly related to the rigour of clinical judgement of pain as the reference standard. Individual data from 1351 patients showed large variation in the selection of neuropathic pain descriptor items by cancer patients with neuropathic pain. LANSS and DN4 items characterized a significantly different neuropathic pain symptom profile from non-neuropathic pain in both tumour- and treatment-related cancer pain aetiologies. CONCLUSIONS: We identified concordance between the clinician diagnosis and screening tool outcomes for LANSS, DN4 and PDQ in patients with cancer pain. Shortcomings in relation to standardized clinician assessment are likely to account for variation in screening tool sensitivity, which should include the use of the neuropathic pain grading system. Further research is needed to standardize and improve clinical assessment in patients with cancer pain. Until the standardization of clinical diagnosis for neuropathic cancer pain has been validated, screening tools offer a practical approach to identify potential cases of neuropathic cancer pain.

An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-LC13 was the first module to be used in conjunction with the core questionnaire, the QLQ-C30. Since the publication of the LC13 in 1994, major advances have occurred in the treatment of lung cancer. Given this, an update of the EORTC QLQ-LC13 was undertaken. METHODS: The study followed phases I to III of the EORTC Module Development Guidelines. Phase I generated relevant quality-of-life issues using a mix of sources including the involvement of 108 lung cancer patients. Phase II transformed issues into questionnaire items. In an international multicenter study (phase III), patients completed both the EORTC QLQ-C30 and the 48-item provisional lung cancer module generated in phases I and II. Patients rated each of the items regarding relevance, comprehensibility, and acceptance. Patient ratings were assessed against a set of prespecified statistical criteria. Descriptive statistics and basic psychometric analyses were carried out. RESULTS: The phase III study enrolled 200 patients with histologically confirmed lung cancer from 12 centers in nine countries (Cyprus, Germany, Italy, Israel, Spain, Norway, Poland, Taiwan, and the UK). Mean age was 64 years (39 - 91), 59% of the patients were male, 82% had non-small-cell lung cancer, and 56% were treated with palliative intent. Twenty-nine of the 48 questions met the criteria for inclusion. CONCLUSIONS: The resulting module with 29 questions, thus currently named EORTC QLQ-LC29, retained 12 of the 13 original items, supplemented with 17 items that primarily assess treatment side-effects of traditional and newer therapies.

Prescriptions of analgesics during complete disease trajectories in patients who are diagnosed with and die from cancer within the five-year period 2005-2009.

BACKGROUND: Even though validation studies of the WHO analgesic ladder have indicated that the simple approach of the analgesic ladder can provide adequate pain control in most patients, prevalence studies have documented a high prevalence of pain in cancer patients. Little is known about how analgesics are actually prescribed for cancer pain. The aim of the study was to study prescriptions of analgesics during the entire disease trajectory in patients dying from cancer within five years of diagnosis. METHODS: Complete national data from the Norwegian Cancer Registry, the Norwegian Prescription Database, the Cause of Death Registry and Statistics Norway were used to study prescriptions of analgesics in a complete study population of all patients dying from cancer within five years of diagnosis in Norway from 2005 to 2009. RESULTS: Of a total of 10,977 subjects who received prescriptions for analgesics between diagnosis and death, 56% started analgesic treatment at step I of the analgesic ladder, 29% started at step II and 14% started at step III. Of the patients starting at step I, 28% continued to step II, 37% bypassed step II and moved directly to step III whereas the remaining 35% remained at step I. Approximately 60% received one or more dispensed prescription of a step III analgesic during the disease trajectory, whereas nearly 20% remained at step I and 20% at step II respectively. CONCLUSION: The study indicates that clinicians seem to individually tailor analgesic treatment instead of applying the stepwise approach in the WHO analgesic ladder. SIGNIFICANCE: Complete national data covering the complete disease trajectory in cancer patients dying within five years of diagnosis. The majority of patients do not receive treatment in concordance with the stepwise approach suggested by the WHO analgesic ladder.

Who experiences higher and increasing breathlessness in advanced cancer? The longitudinal EPCCS Study.

PURPOSE: Breathlessness is a major cause of suffering in advanced cancer. We aimed to determine the symptom trajectory in people with advanced cancer and to identify those at increased risk of experiencing higher or increasing breathlessness over time in advanced cancer. PATIENTS AND METHODS: This was an analysis of the multinational, prospective, longitudinal European Palliative Care Cancer Symptom (EPCCS) study. We included adults with confirmed incurable cancer enrolled in palliative care, with prospective monthly assessments for up to 6 months, withdrawal or death, whichever came first. Symptom severity (0-10 numerical rating scales) was analyzed using multivariate random coefficients regression. RESULTS: A total of 1689 patients (50 % women; mean age 65.7 ± [standard deviation; SD] 12.4 years) were included. Main diagnoses were digestive (31 %), lung (20 %), and breast (17 %) cancers. During a median follow-up of 62 (interquartile range, 0 to 133) days, 65 % were breathless at some point and 36 % of all patients reported moderate/severe breathlessness. The group mean (1.6 points; SD, 2.4) was unchanged over time, but the severity varied markedly between patients and over time. Independent predictors for worse breathlessness were COPD, lung cancer, living alone, lung metastases, anxiety, pain, depression, and lower performance status. Predictors of worsening breathlessness over time were low performance status (p = 0.039) and moderate to severe pain (p = 0.012). CONCLUSION: In the largest longitudinal clinical study to date in advanced cancer alone, breathlessness was frequent and associated with factors including respiratory disease, other concurrent unpleasant symptoms, and impaired performance status. Increase in severity over time was predicted by performance status and pain.

Depression in advanced cancer--assessment challenges and associations with disease load.

BACKGROUND: Patients with advanced cancer commonly experience multiple somatic symptoms and declining functioning. Some highly prevalent symptoms also overlap with diagnostic symptom-criteria of depression. Thus, assessing depression in these patients can be challenging. We therefore investigated 1) the effect of different scoring-methods of depressive symptoms on detecting depression, and 2) the relationship between disease load and depression amongst patients with advanced cancer. METHODS: The sample included 969 patients in the European Palliative Care Research Collaborative-Computer Symptom Assessment Study (EPCRC-CSA). Inclusion criteria were: incurable metastatic/locally advanced cancer and ≥ 18 years. Biomarkers and length of survival were registered from patient-records. Depression was assessed using the Patient Health Questionnaire (PHQ-9) and applying three scoring-methods: inclusive (algorithm scoring including the somatic symptom-criteria), exclusive (algorithm scoring excluding the somatic symptom-criteria) and sum-score (sum of all symptoms with a cut-off ≥ 8). RESULTS: Depression prevalence rates varied according to scoring-method: inclusive 13.7%, exclusive 14.9% and sum-score 45.3%. Agreement between the algorithm scoring-methods was excellent (Kappa = 0.81), but low between the inclusive and sum scoring-methods (Kappa = 0.32). Depression was significantly associated with more pain (OR-range: 1.09-1.19, p < 0.001-0.04) and lower performance status (KPS-score, OR-range = 0.68-0.72, p < 0.001) irrespective of scoring-method. LIMITATIONS: Depression was assessed using self-report, not clinical interviews. CONCLUSIONS: The scoring-method, not excluding somatic symptoms, had the greatest effect on assessment outcomes. Increasing pain and poorer than expected physical condition should alert clinicians to possible co-morbid depression. The large discrepancy in prevalence rates between scoring-methods reinforces the need for consensus and validation of depression definitions and assessment in populations with high disease load.

Validation of the Consensus-Definition for Cancer Cachexia and evaluation of a classification model--a study based on data from an international multicentre project (EPCRC-CSA).

BACKGROUND: Weight loss limits cancer therapy, quality of life and survival. Common diagnostic criteria and a framework for a classification system for cancer cachexia were recently agreed upon by international consensus. Specific assessment domains (stores, intake, catabolism and function) were proposed. The aim of this study is to validate this diagnostic criteria (two groups: model 1) and examine a four-group (model 2) classification system regarding these domains as well as survival. PATIENTS AND METHODS: Data from an international patient sample with advanced cancer (N = 1070) were analysed. In model 1, the diagnostic criteria for cancer cachexia [weight loss/body mass index (BMI)] were used. Model 2 classified patients into four groups 0-III, according to weight loss/BMI as a framework for cachexia stages. The cachexia domains, survival and sociodemographic/medical variables were compared across models. RESULTS: Eight hundred and sixty-one patients were included. Model 1 consisted of 399 cachectic and 462 non-cachectic patients. Cachectic patients had significantly higher levels of inflammation, lower nutritional intake and performance status and shorter survival. In model 2, differences were not consistent; appetite loss did not differ between group III and IV, and performance status not between group 0 and I. Survival was shorter in group II and III compared with other groups. By adding other cachexia domains to the model, survival differences were demonstrated. CONCLUSION: The diagnostic criteria based on weight loss and BMI distinguish between cachectic and non-cachectic patients concerning all domains (intake, catabolism and function) and is associated with survival. In order to guide cachexia treatment a four-group classification model needs additional domains to discriminate between cachexia stages.

Inpatient cardiac rehabilitation and changes in self-reported health related quality of life--a pilot study.

OBJECTIVE: To assess changes in self-reported health related quality of life (HRQoL) among cardiac patients who participated in an inpatient rehabilitation programme. PATIENTS AND METHODS: Medical Outcomes Study Short Form 36 (SF-36) and the MacNew Heart Disease Health-related Quality of Life Questionnaire (MacNew) was used to assess HRQoL at baseline (T1), after rehabilitation (T2) and 5 months after discharge (T3). The rehabilitation programme consisted of physical exercise, theoretical education, group discussions and individual consultations. Friedman's test with Wilcoxon post-hoc test was used to analyse changes between T1, T2 and T3. Effect size (ES) were calculated. RESULTS: Eighty-nine participants were included (79% male) with mean age of 60.0 ± 8.6 years. All SF-36 and MacNew domains showed significant improvement from T1 to T2 (P < 0.05), and all except the SF-36 domain for emotional role with a moderate to large ES. At T3, change and ES are diminished in all domains, except for the physical and social domains of the MacNew. CONCLUSION: These findings indicate an improvement in HRQoL over time among cardiac patients attending the rehabilitation programme, particularly so in the domains of physical role and physical function, vitality, bodily pain and emotional-, physical- and social-well-being, all which are important domains for maintaining an active life. Future randomised studies comparing inpatient- and outpatient-programmes with longer follow-up are necessary to ascertain if such improvements persist and if patients are able to change life-style in line with the stated goals of cardiac rehabilitation (CR).

Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer.

Curative treatment of esophageal cancer with definitive or preoperative high-dose chemoradiotherapy inflicts a major strain on the patients with potentially severe physical, emotional, and social consequences. The aim of this study was to assess various aspects of quality of life and fatigue in long-term survivors following such a treatment. Patients undergoing a potentially curative treatment between 1996 and 2007, and still alive (n= 41) completed quality of life questionnaires of the European Organization for Research and Treatment of Cancer core questionnaire (QLQ-C30) and esophageal cancer module (QLQ-OES18). Twenty patients were treated by surgery alone, and 21 patients were scheduled for high-dose chemoradiotherapy followed by surgery. Five of those patients did not undergo planned surgery. Preoperative chemoradiotherapy consisted of three courses of chemotherapy, cisplatin 100 mg/m(2) and 5-fluorouracil 5000 mg/m(2) in each course and concomitant radiotherapy of a median dose 66 Gy. Quality of life in esophageal cancer patients receiving high-dose chemoradiotherapy was compared with that for esophageal cancer patients who received only surgery, head and neck cancer patients, laryngectomized patients, and a random sample of the general Norwegian population. Esophageal cancer patients treated by high-dose chemoradiotherapy had significantly worse global quality of life as reflected by almost all functional scales and higher fatigue compared with esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. There were no significant differences in quality of life between the esophageal cancer patients receiving high-dose chemoradiotherapy and the laryngectomy patients. Further, the esophageal cancer patients receiving high-dose chemoradiotherapy had higher intensity of other symptoms like general pain, insomnia, nausea/vomiting, diarrhea, and constipation compared with the esophageal cancer patients who received surgery alone, head and neck cancer patients, and the general Norwegian population. High-dose chemoradiotherapy with cisplatin and 5-fluorouracil had a considerable negative long-term effect on global quality of life in patients with resectable esophageal cancer. Fatigue was a prominent long-lasting symptom in these patients.

Using the Mini-Mental State Examination to screen for delirium in elderly patients with hip fracture.

BACKGROUND: The main aim of this paper was to examine the usefulness of the Mini-Mental State Examination (MMSE) for screening delirium in elderly patients with hip fracture. METHODS: The sample included 364 elderly patients with hip fracture admitted to two hospitals in Oslo. Delirium was assessed by the Confusion Assessment Method (CAM) as an approximation of the gold standard, DSM-IV. To evaluate the psychometric properties of the MMSE scale, we used the Mokken nonparametric latent trait model for unidimensional scaling. RESULTS: In total, 76 (21%) patients were diagnosed with delirium based on the CAM, and 141 (43%) had preexisting cognitive impairment. As a screening tool, the recommended MMSE cut-point of 24 showed an acceptable sensitivity of 88% with a specificity of 54%. The prediction of delirium, based on logistic regression on the MMSE total score and on the 5 items selected by the stepwise logistic regression procedure, gave clearly less acceptable results. CONCLUSIONS: Our study indicates that the MMSE may be useful in screening for delirium, but the high percentage of false positives shows that it does not have diagnostic potential in patients with hip fracture.

Classification of pain in cancer patients--a systematic literature review.

One of the aims of the European Palliative Care Research Collaborative (EPCRC) is to achieve consensus on a classification system for cancer pain. We performed a systematic literature review to identify existing classification systems and domains/items used to classify cancer patients with pain. In a systematic search in the databases Medline and Embase, covering 1986-2006, 692 hits were obtained. 92 papers were evaluated to address pain classification. Six standardised classification systems were identified; three of them systematically developed and partially validated. Both pain characteristics and patient characteristics relevant for cancer pain classification were included in the classification systems. All but one of the standardised systems aim at predicting treatment response or adequacy of treatment. Several domains and items used to describe cancer pain but not formally described as part of a classification system were also identified and systematized. The existing approaches to pain classification in cancer patients are different, mostly not thoroughly validated, and none is widely applied. An internationally accepted classification system for cancer pain could improve research and cancer pain management. This systematic review suggests a need for developing an international consensus on how to classify pain in cancer patients.

Pain assessment tools in palliative care: an urgent need for consensus.

At present, there is no universally accepted cancer pain assessment tool for use in palliative care (PC). The European Palliative Care Research Collaborative (EPCRC), therefore, aims to develop an international consensus-based computerised pain assessment tool. As part of this process, we have performed (1) a literature review on pain assessment tools for use in the PC and (2) an international expert survey to gain information on the relevant dimensions for pain assessment in PC. 230 publications were identified, only six met the inclusion criteria. Three further articles were identified through manual searching, totalling 11 different pain assessment tools. Nine tools were multidimensional. Pain intensity was assessed in seven, using various numerical/verbal rating scales (NRS/VRS); five tools focused on pain management. Three publications did not identify the rationale for the need to develop a new tool, and the selection procedure for items/dimensions was not described in six tools. Patient and/or professional expert groups were involved in the development of five tools and only two tools were extensively validated or cross-culturally tested. Thirty-two experts (71%) completed the expert survey and identified 'intensity', 'temporal pattern', 'relief/exacerbation', 'pain quality' and 'location' as the five most relevant dimensions. Most preferred assessment of 'pain intensity' was by NRS rather than VRS. Time windows extending 24 h were regarded as less relevant. Development of PC pain assessment tools seems to be a continuous process, which does not adhere to systematic guidelines, thus does not contribute to a universally accepted tool. No tool contained all relevant dimensions as defined by the experts. Many tools focused on particular dimensions, suggesting that specific research interests may drive the tool development process. Extensive literature reviews, expert and patient input and clinical studies are a needed approach in the development of a new consensus-based pain assessment tool.

The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation.

High-dose chemotherapy followed by haematopoietic stem cell transplantation can be associated with high physical and emotional distress levels and reduced quality of life. Systematic prospective measurement of impact of therapy on patient quality of life can aid treatment choices and provide better patient information. We describe the development of a high-dose chemotherapy questionnaire module to supplement the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Phases 1-3 of module development were conducted in United Kingdom, Germany, Austria and Norway, according to EORTC QOL Group guidelines. Forty-eight quality of life (QOL) issues were generated from the literature searches and interviews with health care professionals (n=24) and patients (n=92). This produced a 50 item provisional module. Further testing in 169 patients resulted in the QLQ-HDC29 module, containing 29 items, conceptualised into six multi-item scales and eight single items. The EORTC QLQ-C30, supplemented by QLQ-HDC29 will provide a comprehensive QOL measure for the international clinical trials of high-dose chemotherapy.

A prospective study of health-related quality of life, fatigue, anxiety and depression 3-5 years after stem cell transplantation.

Health-related quality of life (HRQOL), fatigue and psychological distress were prospectively assessed in 248 cancer patients treated with allogeneic (SCT, N=61), or autologous (ASCT, N=69) stem cell transplantation or conventional chemotherapy (CT, N=118) of whom 128 completed the assessments after 3 years. The European Organization for Treatment and Research of Cancer Core Quality of Life Questionnaire and the Hospital Anxiety and Depression Scale were administered nine (SCT/ASCT groups) or seven times (CT group) during the first year. The Fatigue Questionnaire was added at the final assessment. The SCT group displayed greater changes from baseline scores than the ASCT group, with more symptoms in the first months post transplant. A gradual improvement was found in both groups during the following 4-6 months, before stabilizing at baseline levels. Only minor changes were observed after the first year. All groups reported more fatigue than the population values after 3 years (P<0.01). The ASCT group also reported less optimal HRQOL (P<0.01-0.0001). No differences were found in anxiety and depression. Despite a faster recovery during the first months after transplant, the ASCT patients reported poorer functioning and more fatigue compared to the SCT group after 3 years. This suggests a need for a closer follow-up of these patients with special emphasis on functional status and fatigue.

Physical exercise results in the improved subjective well-being of a few or is effective rehabilitation for all cancer patients?

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.

Assessing the consistency of psychometric properties of the HRQoL scales within the EORTC QLQ-C30 across populations by means of the Mokken Scaling Model.

This paper demonstrates how the Mokken Scaling Model and other statistical tools may be useful in assessing the consistency of psychometric properties of health-related quality of life (HRQoL) scales across various populations. The main focus is the psychometric performance of the scales proposed for the EORTC QLQ-C30 in seven patient groups totalling more than 2,000 cancer patients. All scales performed satisfactorily in the total sample with the exception of the role functioning and cognitive functioning scales, which failed in terms of reliability and item discriminant validity. The descriptive statistics for the scales show that several of them, particularly those that build upon only two items, have discrimination problems at the extremes, visible in the high percentages at the maximum or the minimum observed values. The scalability analysis in the subsamples showed that the essential assumption in the Mokken Scaling Model of equal item step order does not hold for the cognitive functioning, emotional functioning and physical functioning scales. We conclude that the Mokken Scaling Model is well suited to the purpose of examining the generalizability of HRQoL scales across subpopulations although a global statistical test of the fit of the measurement model is not available.

Health-related quality of life 1 year after allogeneic or autologous stem-cell transplantation: a prospective study.

PURPOSE: To evaluate health-related quality of life (HRQOL) in adults treated with high-dose chemotherapy followed by allogeneic (SCT) and autologous (ASCT) stem-cell transplantation 1 year after transplantation, using data from concurrent lymphoma patients receiving combination chemotherapy (CT) as a reference. MATERIALS AND METHODS: Forty-one leukemia patients (SCT group), 51 lymphoma patients (ASCT group), and 85 CT patients completed the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline and after 1 year. RESULTS: The SCT group (median age, 36 years) had better functioning scores and less symptomatology at baseline compared with the ASCT (median age, 41 years) and CT (median age, 37 years) groups. Statistically significant differences of 10 or more points on the 0 to 100 scales were found for 10 of 15 scales and items (P< or =.01) between the SCT and ASCT groups. Global quality of life (79 v 58, P<.0001), role function (83 v 65, P = .001), sleep disturbances (6 v 28, P<.0001), and fatigue (25 v 44, P = .0001) deviated most. The differences were 10 or more points for seven of 15 scales and items comparing the SCT and CT groups, with sleep disturbances (6 v 35, P<.0001) and pain (11 v 29, P<.01) deviating most. Differences across groups were smaller after 1 year; cognitive function was the only scale with a statistically significant difference (ASCT 80 v CT 89; P = .002). Patterns of change in HRQOL scores were different between groups during follow-up. A great improvement was found in the ASCT group (P<.01 for emotional and role function, fatigue, appetite, and constipation), whereas no significant changes were observed for the SCT group. CONCLUSION: Prospective studies with extended follow-up periods are necessary to separate a slow recovery process from more permanently reduced HRQOL after transplantation and to examine the late side effects from previous treatment.

The course of anxiety and depression during the first year after allogeneic or autologous stem cell transplantation.

Psychological distress is frequently reported in transplant survivors. We prospectively assessed anxiety and depression before transplant, in the isolation period and during a follow-up period of 1 year. The Hospital Anxiety and Depression Scale (HADS) was administered to 131 cancer patients treated with high-dose chemotherapy followed by allogeneic (SCT) or autologous (ASCT) stem cell transplantation, and a concurrent group of 123 lymphoma patients receiving standard chemotherapy (CT) who served as a reference group. Relatively low levels of anxiety and depression were found. The level of anxiety slightly declined from baseline during follow-up (mean scores SCT: from 5.3 to 3.6, CT: from 6.0 to 4.2) or remained fairly stable (ASCT: from 5.4 to 4.8). The level of depression peaked when the transplant patients were in protective isolation or shortly thereafter (SCT: 6.1, ASCT: 6.4), but stabilized at baseline levels after 4 months. The highest level of depression in the CT group was reported 4 months after start of chemotherapy (3.4). Elevated levels of anxiety and depression at baseline predicted more anxiety and depression at the later assessments (P values < 0.0001). The ASCT group had higher levels of anxiety after 1 year (mean 4.8) than those found in the other two groups (SCT: 3.6, CT: 4.2), although they were not statistically significant. This study revealed lower than expected levels of anxiety and depression after intensive chemotherapy followed by SCT or ASCT. There was a decline in psychological distress during the 1-year follow-up period.