Quality of life in clinical cancer trials: experience and perspective of the European Organization for Research and Treatment of Cancer.
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Clinical Trials, Phase II as Topic↗
Biomedical subjects
S Kaasa
Publications and source records attributed to S Kaasa.
[Good pain relief or euthanasia?].
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Euthanasia↗
[From the hospice movement to palliative medicine].
The "modern" hospice movement was established at the beginning of the 1960s in Great Britain. Philosophical issues and a holistic treatment model have been emphasized in order to meet the physical, emotional, social and psychological needs of dying patients. Less time has been devoted to research. Several hospices now find themselves at crossroads. It is necessary to clarify key strategic goals. More patients will be in need of palliation in the next decades. A 35-40% increase in the incidence of cancer is predicted from now up to the year 2010. More knowledge must be obtained about patients with a limited life expectancy. The patients' needs will best be taken care of by incorporating a multidisciplinary team into the clinic. It is also important to increase the teaching about palliative medicine at medical school. The first unit of palliative has been established at the University Hospital, Trondheim. Similar clinics should be established at the other university hospitals in Norway.
Hospice Care↗
Quality of life in adult cancer patients treated with bone marrow transplantation--a review of the literature.
There is now an increasing interest in measuring quality of life (QOL) in cancer patients. Information on psychosocial issues and the patients' QOL give a more comprehensive evaluation of the treatment outcome than survival and relapse free intervals alone. Bone marrow transplantation (BMT) has become a standard, curative treatment in haematological diseases such as leukaemia and lymphomas. However, serious physical and psychological side effects are experienced by some patients. A review of the literature on QOL in adult BMT patients shows that the development in post-BMT research on psychosocial factors is slowly progressing. Most studies are retrospective with small sample sizes, and only five of 48 studies fulfilled our preset quality criteria. Identification of factors that are predictive for poor post-BMT outcome might provide a basis for targeted support programmes. This underlines the necessity of undertaking prospective studies using reliable and well-validated methods for measuring QOL in this patient group.
Adult↗
The EORTC core quality of life questionnaire (QLQ-C30): validity and reliability when analysed with patients treated with palliative radiotherapy.
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. 247 patients completed the EORTC QLQ-C30 before palliative radiotherapy and 181 after palliative radiotherapy. The questionnaire was well accepted with a high completion rate in the present patient population consisting of advanced cancer patients with short life expectancy. In addition, the questionnaire was found to be useful to detect the effect of palliative radiotherapy over time. The scale reliability was excellent for all scales except the role functioning scale. Excellent criterion validity was found for the emotional functioning scale where it was correlated with GHQ-20. Performance of the questionnaire was improved after the second evaluation as compared with the first. The present study shows that the EORTC QLQ-C30 is found to be practical and valid in measuring quality of life in patients with advanced disease.
Adult↗
The use of non-proven therapy among patients treated in Norwegian oncological departments. A cross-sectional national multicentre study.
A national multicentre study was performed to investigate the prevalent use of "alternative medicine", here called "non-proven therapies (NPT)", applied among Norwegian cancer patients. Of 911 patients invited to take part in the study, 642 were included in the analysis. Demographic characteristics were collected for all patients. The participating physicians gave information about the patients' clinical characteristics. Among 630 evaluable patients, 20% had been or were present users of NPTs for their oncological disease. The preferred methods were healing by hand and faith healing. Herbs, vitamins, diets and Iscador were other popular methods. As many as 40% of the users of NPTs had used NPTs earlier for non-malignant diseases. Elderly patients were less likely to use NPTs. Use was high in the northern part of Norway.
Adolescent↗
Using quality of life assessment methods in patients with advanced cancer: a clinical perspective.
The incidence of cancer is expected to increase in most European countries by at least 20-30% in the next two decades. This change in incidence, combined with probably small changes in cure rate, will call for an increased effort in palliative oncology. Most patients with advanced malignant diseases have various unpleasant symptoms which are inadequately treated. In assessing patients' symptoms and well being, health-related quality of life (HRQL) should be the primary endpoint. Several HRQL instruments have been found to be valid for use in cancer clinical trials. The EORTC QLQ-C30 is one among several cancer-specific HRQL instruments. The QLQ-C30 is composed of nine multi-item scales and six single item measures. This instrument is developed to be used in conjunction with disease and/or specific modules.
Clinical Trials as Topic↗
Patient self-reported and clinician-rated quality of life in head and neck cancer patients: a cross-sectional study.
One to six years after treatment for head and neck cancer, 68 patients were asked to fill in a questionnaire at home with a subsequent examination at the out-patient clinic of the Ullevål University Hospital. 50 patients (74%) both answered the questionnaire (the EORTC QLQ-C30, a diagnosis specific questionnaire module, the GHQ-20, and two questions from a population survey) and presented for examination where the clinician rated side effects after treatment, and filled in the Karnofsky Performance Status and the Spitzer's Quality of Life index. No patients had relapse or second primary tumours at the time of examination but a variety of post-treatment side effects were recorded. The patients appeared to report lower quality of life including more post-treatment side effects compared with the clinician's assessments. The cost-benefit of the standard clinical follow-ups in terms of increased survival may be questioned. Patients seem to need better support in coping with the physical and psychosocial problems which often appear.
Adult↗
Self-reported satisfaction with life and physical health in long-term cancer survivors and a matched control group.
The response to two validated questions assessing self-reported satisfaction with life and physical health were compared between 204 long-term head and neck cancer survivors from a randomised radiotherapy trial and 766 matched controls. The control group, participants in a large population health survey in a county in the middle of Norway, was matched to the patients with regard to age, gender, marital status/family type and education. Compared with the controls, the patients reported significantly lower satisfaction with life and physical health. Sixty-four per cent of the patients were satisfied with life and 44% felt strong and healthy while the percentages of the controls were 82% and 52%, respectively. Clinical and sociodemographic variables were poor predictors of the patients' responses. Clinicians must be aware of the psychosocial morbidity in the growing population of cured cancer patients, and intervention studies are needed in patients at risk, in order to determine whether this morbidity can be prevented, reduced, or treated.
Adult↗
Psychological distress in head and neck cancer patients 7-11 years after curative treatment.
Long-term survivors of head and neck cancer may suffer from psychological distress and reduced quality of life because of late side-effects of the treatment. In a follow-up study of patients randomised to two different radiation fractionating regimens, 204 patients filled in a mailed questionnaire 7-11 years after treatment. The questionnaire consisted of the General Health Questionnaire, 20-item version (GHQ-20), and the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30). There were no differences in psychological distress between patients receiving conventional radiotherapy and those receiving a slightly hypofractionated regimen. A high prevalence of psychological distress was found in both treatment groups (30% of 'cases' according to the GHQ-20), especially in patients with impaired cognitive or social function, or with pain. Clinicians need to be aware of this morbidity, and their ability to detect patients with psychological problems needs to be improved. The GHQ-20 can facilitate the communication process in a clinical setting. With an increased awareness of these problems and by using valid instruments for identification of patients at risk, the clinicians may intervene and help the patients to reduce their psychological distress.
Adult↗
Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire.
PURPOSE: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated instrument that assesses health-related quality of life (HRQOL) in cancer patients. It is used in cancer clinical trials in Europe, Canada, and the United States, and has demonstrated high reliability and validity in different groups of cancer patients. Despite thorough testing of reliability and validity, we have not identified any reports on its test/retest reliability; thus, a test/retest study was performed at the Norwegian Radium Hospital (NRH). MATERIALS AND METHODS: Cancer patients from the outpatient clinic who were off treatment for > or = 3 months were eligible for the study. The EORTC QLQ-C30 was given to the patients when they presented for their visit. The second questionnaire was received by the patients 4 days later. Of 291 eligible patients, 270 (93%) agreed to participate and 190 (73%) completed both questionnaires. RESULTS: The test/retest reliability measured by Pearson's correlation coefficient was high for all functional scales, with a range from .82 for cognitive and role function to .91 for physical function. The r value for global HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue, and pain--the coefficients were .63, .83, and .86, respectively. The single-item coefficients ranged from .72 for diarrhea to .84 for financial impact. The Spearman rank correlation was in the same range for all dimensions. CONCLUSION: The EORTC QLQ-C30 seems to yield high test/retest reliability in patients with various cancer diagnoses whose condition is not expected to change during the time of measurement.
Adolescent↗
Quality of life during pelvic radiotherapy.
BACKGROUND: A randomized clinical trial was carried out to evaluate the effect of a diet low in fat and lactose to prevent acute radiation-induced diarrhea. The effect of the diet treatment on the patients' health related quality of life was studied. METHODS: 143 women with gynecological malignancies were included. The daily number and consistency of stools, use of antidiarrheal agents and quality of life measured by using the EORTC Core Quality of life Questionnaire 36 item version, were recorded before therapy, in the last week of treatment, six weeks after end of radiotherapy and every eight weeks during one year's follow up. RESULTS: Fourteen patients (23%) in the intervention group reported diarrhea during radiotherapy, compared to 32 (48%) in the control group (p < 0.01). This difference was not seen with the EORTC questionnaire. The diet intervention did not interfere with emotional and social well-being. Within the control group diarrhea was associated with higher scores on the physical functioning scale (p < 0.01), and fatigue and malaise scale (p < 0.01) indicating more pronounced dysfunction of symptoms. CONCLUSION: When measuring specific phenomena such as diarrhea in a clinical trial, the EORTC questionnaire does not seem to be as sensitive as specific trial-related instruments. Diet intervention during radiotherapy might influence the patients' ability to cope with diarrhea by giving them more control over their own situation.
Acute Disease↗
Quality of life in patients treated for head and neck cancer: a follow-up study 7 to 11 years after radiotherapy.
PURPOSE: To compare health-related quality of life factors in 845 head and neck cancer patients randomized to receive either conventional radiotherapy (2 Gy, 5 days-a-week) or a hypofractionated regimen (2.35 Gy, 4 days-a-week), a follow-up study was carried out 7 to 11 years after treatment in the surviving patients, representing 30% of the original patient number. METHODS AND MATERIALS: The cancer-specific EORTC Core Quality of Life Questionnaire (30 item version; the EORTC QLQ-C30) and a 19 item head and neck cancer-specific questionnaire were mailed to the 245 surviving patients of the trial. The EORTC QLQ-C30 is comprised of six multi-item function scales, three symptom scales, and six single items which assess both symptoms and economic consequences of the disease. Two hundred and four patients (83%) completed the questionnaire. The two groups of patients (N = 103 and N = 101) treated by different fractionating schedules, were comparable with regard to sociodemographic variables, tumor site, treatment variables (including different types of surgical treatment), and secondary primary cancers. Patients in the conventional group had more advanced disease and a higher recurrence rate compared to patients in the hypofractionated group. RESULTS: Unexpectedly, patients in the hypofractionated group, reported similar or better quality of life compared to patients in the conventional fractionated group. Patients in both groups described a high level of symptoms, like dryness in the mouth and mucus production. Clinical and sociodemographic variables did not explain variance in social function, emotional function or fatigue, except for the type of surgery performed, which significantly influenced the patients' emotional function. CONCLUSION: Long-term survivors of head and neck cancer reported a high level of disease and treatment related symptoms. Emotional function was significantly influenced by the type of surgical procedure. Strategies for future trials in head and neck cancer should continue to attempt to stress conservative surgical approaches and coordinated adjuvant therapy to maximize local regional control and quality of life. Functional and emotional outcome are important parameters which should prospectively be evaluated in future clinical trials in head and neck cancer.
Adult↗
The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life.
The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international field studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13. In this paper, the results of an evaluation of the QLQ-LC13 are reported. The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). It was administered to patients with non-resectable lung cancer recruited from 17 countries. In total, 883 and 735 patients, respectively, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. With one exception (problems with a sore mouth), the change of toxicity measures over time was related specifically to either chemo- or radiotherapy. However, the single item on neuropathy did not measure adequately the full range of symptoms. The hypothesised scale structure of the questionnaire was partially supported by the data. The multi-item dyspnoea scale met the minimal standards for reliability (Cronbach alpha coefficient > 0.70), while the pain items did not form a scale with reliability estimates acceptable for group comparisons. In conclusion, the results form international field testing lend support to the EORTC QLQ-LC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. In a few areas, however, the questionnaire module could benefit from further refinements. In addition, its performance over a longer period of time still needs to be investigated.
Adult↗
Development of a European Organization for Research and Treatment of Cancer (EORTC) questionnaire module to be used in quality of life assessments in head and neck cancer patients. EORTC Quality of Life Study Group.
A head and neck cancer specific questionnaire module designed to be used in quality of life assessments before, during, and after radiotherapy and surgery, with or without combinations with chemotherapy has been developed in accordance with guidelines given by the EORTC Quality of Life Study Group. Relevant issues were generated by means of literature search, and interviews with specialists and patients. Pre-testing of a preliminary questionnaire module was performed in patients from Norway, Sweden, Denmark, United Kingdom and French-speaking Belgium. The resulting head and neck cancer module, the EORTC QLQ-H&N37, includes 37 items concerning disease and treatment related symptoms, social function and sexuality. By using a combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&N37, health-related quality of life measurements may be compared between studies in different cancer populations, and still be sensitive to changes in the target population.
Europe↗
Polychemotherapy in advanced non small cell lung cancer: a meta-analysis.
We did a meta-analysis of all published polychemotherapy vs supportive care clinical trials in patients with non-resectable non small cell lung cancer. 7 studies with more than 700 patients were selected. We used the number of deaths at 3, 6, 9, 12, and 18 months as the endpoints because we were unable to obtain all the individual data. Our analysis showed a reduction in mortality during the first 6 months with polychemotherapy. Although small, this increase in survival, together with an improved quality of life, suggests that polychemotherapy should be recommended for patients with non-resectable non small cell lung cancer.
Antineoplastic Combined Chemotherapy Protocols↗
Psychological distress in cancer patients with advanced disease.
The objective of this study is to explore the nature and extent of the cognitive behavioral response to treatment, and the accompanying anxiety and/or depression in cancer patients with advanced disease. In a multicenter study, 247 patients treated with palliative radiotherapy filled out a questionnaire before start of treatment. The questionnaire consisted of Impact of Event Scale (IES), General Health Questionnaire (GHQ-20), and two questions assessing pain intensity. Seventy percent of the patients reported a high level of psychological distress. The mean score of the patient population on the IES was 14.4 (IES intrusion) and 15.3 (IES avoidance). The mean Likert score on the GHQ-20 was 27.3. Patients with poor performance status and pain were most distressed. In order to improve patients' care and support, cases at risk must be identified. In the present population, psychological distress is related to pain and reduced performance status.
Adult↗
The effect of a low fat, low lactose diet on nutritional status during pelvic radiotherapy.
The food intake and nutritional status were assessed before, during and after radiotherapy in 143 women with gynaecological malignancies randomized to either a low fat, low lactose diet or a normal diet during treatment. The patients on the low fat, low lactose diet had an intake of fat of 34 g per day during radiotherapy, 41 g per day 6 weeks after radiotherapy and 52 g per day 1 year after radiotherapy, when they were no longer on the diet. The intake in the control group was 57 g per day, 67 g per day and 66 g per day respectively. The total energy intake was reduced in both groups during radiotherapy. The reduced intake of energy resulted in weight loss, greatest in the intervention group. 1 year after radiotherapy both groups had almost regained their initial weight. No marked changes were observed in nutritional status as a result of decreased nutritional intake during radiotherapy.
Journal Article↗