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The clinical importance of routine drug monitoring of serum concentrations of morphine, morphine-6-glucuronide (M6G) and morphine-3-glucuronide (M3G) during chronic morphine therapy is not established. We measured morphine, M6G and M3G serum concentrations in cancer pain patients receiving oral (n = 263, median dose 80 mg/24 hours) or subcutaneous (sc) (n = 35, median dose 110 mg/24 hours) morphine. Regression analyses were performed to investigate if serum concentrations of morphine, M3G and M6G predicted pain intensity (Brief Pain Inventory), health-related quality-of-life variables (EORTC QLQ-C30) and cognitive function (Mini-Mental Score). Serum concentrations were also compared in patients categorized as morphine 'treatment successes' and 'treatment failures'. We observed that serum concentrations of morphine, M6G or M3G did not predict pain intensity, cognitive function, nausea or tiredness. 'Treatment failures' caused by nausea, tiredness, cognitive failure or constipation did not have statistically significant different morphine, M6G and M3G serum concentrations than patients classified as 'treatment successes'. In conclusion, this study did not observe any concentration-effect relationships of morphine, M3G or M6G with pain intensity, nausea, constipation, tiredness or cognitive failure in blood samples obtained during routine clinical drug monitoring in cancer patients. This result suggests that therapeutic drug monitoring as a routine tool during chronic morphine treatment has limited value for clinical decision making.
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PMID:Routine drug monitoring of serum concentrations of morphine, morphine-3-glucuronide and morphine-6-glucuronide do not predict clinical observations in cancer patients. 1469 19

The purpose of this study was to test the validity and reliability of the Taiwan Chinese translation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3) and Quality of Life Questionnaire Lung Cancer-13 (QLQ-LC13) questionnaires. Consecutively 51 patients with lung cancer undergoing active chemotherapy and 48 such patients undergoing regular follow-up completed the questionnaires. The intraclass correlation between test and retest ranged from 0.46 to 0.85 for the QLQ-C30 and was 0.76 for dyspnea for the QLQ-LC13. The kappa coefficients between test and retest ranged from 0.51 to 0.73 for single items of the QLQ-C30 and 0.49-0.68 for five of the nine items in the QLQ-LC13. The Cronbach's alpha coefficients were > or = 0.70 for all scales of the two questionnaires apart from that of cognitive functioning. The correlation coefficients between indices measuring similar dimensions of the EORTC QLQ-C30 and the SF-36 questionnaires ranged from 0.43 to 0.73, and that between the dyspnea scales of the two EORTC questionnaires was 0.70. Patients in the follow-up group revealed higher scores of global status/quality of life, and lower scores of nausea/vomiting, as also physical functioning. The questionnaires could also detect expected adverse effects of radiotherapy, cisplatin, and paclitaxel.
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PMID:Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. 1505 6

The Turkish version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire version 2.0 (EORTC QLQ-C30 v.2.0) has started to be used in clinical trials recently. The objective of the study was to evaluate the validity and reliability of the Turkish version of the EORTC QLQ-C30 v.2.0 and the correlation between the Karnofsky Performance Scale (KPS) and the EORTC QLQ-C30. Two hundred and two lung cancer patients were included in the study between January and March 2000. All the subscales met the minimal standards of reliability (Cronbach's alpha > or = 0.70). Only the role functioning scale differed among the three disease stages of patients (local, locoregional and metastatic). There was no statistically significant difference among therapy types. All interscale correlations were statistically significant (P < 0.01). The strongest correlations were found among the physical functioning, role functioning and fatigue scales. Social functioning was closely related with physical, role, emotional and cognitive functioning. The weakest correlations were between nausea/vomiting and the other scales. Global quality of life (QOL) was substantially correlated with most of the scales except cognitive functioning. The coefficients for the correlation between the items differed between 0.12 and 0.97 and all the subscales were strongly correlated with the scales which they formed. The highest correlation between the EORTC QLQ-C30 and KPS was for physical functioning (r = 0.62, P < 0.05). The Turkish version of the EORTC QLQ-C30 is a valid (by means of interscales validity) and reliable instrument for Turkish lung cancer patients and can be used in clinical studies but needs supporting by the reference data on the QOL of the Turkish population.
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PMID:The European Organization for Research and Treatment of Cancer QLQ-C30: an examination into the cultural validity and reliability of the Turkish version of the EORTC QLQ-C30. 1511 69

The growing interest in the mental health and quality of life of cancer patients, has been the major reason for conducting this study. The aims were to compare advanced cancer patients' responses to Hospital Anxiety and Depression (HAD) scale with those to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0), as well as the impact of quality of life dimensions (as measured by EORTC QLQ-C30) on the levels of anxiety and depression. The analysis, conducted in 120 advanced cancer patients, showed that the most significant associations were found between emotional functioning and HAD-T (total sum of scores) (r=-0.747; p < 0.0005), HAD-A (anxiety) (r=-0.725; p < 0.0005) and HAD-D (depression) (r=-0.553; p < 0.0005). In the prediction of HAD-T, the contribution of physical, emotional, role, and social functioning along with nausea-vomiting, dyspnea, sleep disturbance and gender is high. For anxiety, the predictor variables were physical, role, cognitive, emotional, and social functioning, followed by dyspnea, sleep disturbance, and appetite loss, while depression was predicted by physical, role, emotional, and social functioning, the symptoms of nausea-vomiting, pain, sleep disturbance, constipation, as well as the variables of age, gender, anticancer treatment and performance status. Concluding, psychological morbidity, in this patient population, was predominantly predicted by the emotional functioning dimension of EORTC QLQ-C30.
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PMID:Assessment of anxiety and depression in advanced cancer patients and their relationship with quality of life. 1615 70

This study aimed at developing a shortened version of the EORTC QLQ-C30, one of the most widely used health-related quality of life questionnaires in oncology, for palliative care research. The study included interviews with 41 patients and 66 health care professionals in palliative care to determine the appropriateness, relevance and importance of the various domains of the QLQ-C30. Item response theory methods were used to shorten scales. Patients and health care professionals rated pain, physical function, emotional function, fatigue, global health status/quality of life, nausea/vomiting, appetite, dyspnoea, constipation, and sleep as most important. Therefore, these scales/items were retained in the questionnaire. Four scales were shortened without reducing measurement precision. Important dimensions not covered by the questionnaire were identified. The resulting 15-item EORTC QLQ-C15-PAL is a 'core questionnaire' for palliative care. Depending on the research questions, it may be supplemented by additional items, modules or questionnaires.
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PMID:The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. 1616 4

The study aim was to explore which symptoms/problems cancer patients in palliative care consider most distressing, and to investigate how prioritization at first contact was associated with patient-assessed symptom intensity and change in intensity over time. Initially, 175 patients named and prioritized their five most distressing symptoms. Weekly, they completed the following self-assessment questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, Edmonton Symptom Assessment System, and the Hospital Anxiety and Depression Scale. Initial symptom intensity scores and weekly changes were calculated and compared with prioritization of the same symptom. Pain, fatigue, physical function, appetite, nausea/vomiting, dyspnea, and depression were the symptoms most often prioritized. Priority was associated with initial scoring of pain, appetite, nausea/vomiting, dyspnea, constipation, depression, and anxiety, but not with fatigue, physical function, role function, or inactivity. Priority was associated with change in symptom intensity for pain, reduced appetite, nausea/vomiting, and constipation. Symptom prioritization may be a useful guide to choice of treatment as well as to longitudinal symptom evaluation.
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PMID:Symptom priority and course of symptomatology in specialized palliative care. 1656 14

Bone disease is an important feature of multiple myeloma, and hypercalcaemia is a frequent complication of this disease. We examined the association between serum calcium and quality of life (QOL) scores of 686 multiple myeloma patients at the time of diagnosis. Data from two Nordic studies using the EORTC QLQ-C30 questionnaire were analysed by means of linear regression analysis and a curve fitting program. Serum calcium was independently related to appetite loss, nausea/vomiting and physical functioning (P < 0.001) and to cognitive functioning (P = 0.001), i.e. scores reflecting symptoms that are well known in non-malignant hypercalcaemia. In addition, we found a highly significant independent relationship between serum calcium and the scores for fatigue and pain (P < 0.001). Serum calcium appeared to be as strong a predictor for fatigue as the concentration of haemoglobin. A cubic model (y = a + bx3) fitted the data slightly better than the simple linear model (y = a + bx) and suggested worsening QOL scores at levels of serum calcium above 2.5-3.0 mmol/L. Hypercalcaemia in patients with multiple myeloma seems to be associated with the same symptoms as in non-malignant hypercalcaemia. In addition, an increased level of serum calcium may aggravate the pain and fatigue caused by the skeletal disease itself.
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PMID:Serum calcium is an independent predictor of quality of life in multiple myeloma. 1703 19

Over the years there has been a great deal of controversy on the effect of vitamin C on cancer. To investigate the effects of vitamin C on cancer patients' health-related quality of life, we prospectively studied 39 terminal cancer patients. All patients were given an intravenous administration of 10 g vitamin C twice with a 3-day interval and an oral intake of 4 g vitamin C daily for a week. And then we investigated demographic data and assessed changes in patients' quality of life after administration of vitamin C. Quality of life was assessed with EORTC QLQ-C30. In the global health/quality of life scale, health score improved from 36+/-18 to 55+/-16 after administration of vitamin C (p=0.001). In functional scale, the patients reported significantly higher scores for physical, role, emotional, and cognitive function after administration of vitamin C (p<0.05). In symptom scale, the patients reported significantly lower scores for fatigue, nausea/vomiting, pain, and appetite loss after administration of vitamin C (p<0.005). The other function and symptom scales were not significantly changed after administration of vitamin C. In terminal cancer patients, the quality of life is as important as cure. Although there is still controversy regarding anticancer effects of vitamin C, the use of vitamin C is considered a safe and effective therapy to improve the quality of life of terminal cancer patients.
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PMID:Changes of terminal cancer patients' health-related quality of life after high dose vitamin C administration. 1729 43

The EORTC QLQ-C30 health-related quality of life (HRQoL) questionnaire was developed for use in clinical cancer trials. It has also been applied in studies of patients with chronic nonmalignant pain in spite of nondocumented validity. Validation of the EORTC QLQ-C30 in this patient population and comparison with the traditional first choice HRQoL instrument in chronic nonmalignant pain, the SF-36, are, therefore, required. Two hundred eighty-six patients admitted to the tertiary multidisciplinary pain center at St. Olavs University Hospital in Trondheim, Norway, completed both the EORTC QLQ-C30 and the SF-36 at admittance. Correlations between EORTC QLQ-C30 and SF-36 measures of the same concept were between 0.70 and 0.81 for all five domains covered by both instruments. Internal consistency was below 0.70 for the EORTC QLQ-C30 scales physical functioning (0.57), pain (0.68), role functioning (0.43), cognitive functioning (0.66), and nausea/vomiting (0.53), as well as the SF-36 scale role emotional functioning (0.66). Large floor or ceiling effects were seen for several EORTC QLQ-C30 scales. While SF-36 addresses no other symptoms than pain and fatigue, the EORTC QLQ-C30 also includes sleep, financial difficulties, nausea/vomiting, dyspnea, appetite loss, constipation, and diarrhea. Even though some EORTC QLQ-C30 scales have unsatisfactory internal consistency, EORTC QLQ-C30, similar to SF-36, has overall acceptable psychometric properties. The EORTC QLQ-C30 is a valid alternative to the SF-36 when a broader assessment of symptoms is desired.
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PMID:Validation and comparison of the health-related quality-of-life instruments EORTC QLQ-C30 and SF-36 in assessment of patients with chronic nonmalignant pain. 1761 79

It remains unclear whether any aspect of quality of life has a role in predicting survival in an unselected cohort of patients with gastro-oesophageal cancer. Therefore the aim of the present study was to examine the relationship between quality of life (EORTC QLQ-C30), clinico-pathological characteristics and survival in patients with gastro-oesophageal cancer. Patients presenting with gastric or oesophageal cancer, staged using the UICC tumour node metastasis (TNM) classification and who received either potentially curative surgery or palliative treatment between November 1997 and December 2002 (n=152) participated in a quality of life study, using the EORTC QLQ-C30 core questionnaire. On univariate analysis, age (P<0.01), tumour length (P<0.0001), TNM stage (P<0.0001), weight loss (P<0.0001), dysphagia score (P<0.001), performance status (P<0.1) and treatment (P<0.0001) were significantly associated with cancer-specific survival. EORTC QLQ-C30, physical functioning (P<0.0001), role functioning (P<0.001), cognitive functioning (P<0.01), social functioning (P<0.0001), global quality of life (P<0.0001), fatigue (P<0.0001), nausea/vomiting (P<0.01), pain (P<0.001), dyspnoea (P<0.0001), appetite loss (P<0.0001) and constipation (P<0.05) were also significantly associated with cancer-specific survival. On multivariate survival analysis, tumour stage (P<0.0001), treatment (P<0.001) and appetite loss (P<0.0001) were significant independent predictors of cancer-specific survival. The present study highlights the importance of quality of life (EORTC QLQ-C30) measures, in particular appetite loss, as a prognostic factor in these patients.
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PMID:The relationship between quality of life (EORTC QLQ-C30) and survival in patients with gastro-oesophageal cancer. 1826 90


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