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Some results from MedLine, searching for C30, access provided by Community of Science in 1996

Citation:Kaasa S, Bjordal K, Aaronson N, Moum T, Wist E, Hagen S, Kvikstad A,The EORTC core quality of life questionnaire (QLQ-C30): validity andreliability when analysed with patients treated with palliative radiotherapy.,Eur J Cancer 31A: 13-14, 2260-3, Dec, 1995.
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)is designed to measure cancer patients' physical, psychological and socialfunctions. The questionnaire is composed of multi-item scales and singleitems. 247 patients completed the EORTC QLQ-C30 before palliative radiotherapyand 181 after palliative radiotherapy. The questionnaire was well acceptedwith a high completion rate in the present patient population consistingof advanced cancer patients with short life expectancy. In addition, thequestionnaire was found to be useful to detect the effect of palliativeradiotherapy over time. The scale reliability was excellent for all scalesexcept the role functioning scale. Excellent criterion validity was foundfor the emotional functioning scale where it was correlated with GHQ-20.Performance of the questionnaire was improved after the second evaluationas compared with the first. The present study shows that the EORTC QLQ-C30is found to be practical and valid in measuring quality of life in patientswith advanced disease.

Citation:Osoba D, Zee B, Pater J, Warr D, Kaizer L, Latreille J, Psychometricproperties and responsiveness of the EORTC quality of Life Questionnaire(QLQ-C30) in patients with breast, ovarian and lung cancer., Qual LifeRes 3: 5, 353-64, Oct, 1994.
The QLQ-C30, a health-related quality of life questionnairedeveloped for use in patients with cancer, has been previously validatedin patients with lung cancer and head and neck cancer. In this study, furthervalidation was carried out for 535 patients, including patients with breastcancer (n = 143) and ovarian cancer (n = 111) for whom there is no previouslypublished validation, as well as patients with lung cancer (n = 160) anda heterogeneous group of other cancers (n = 121). All patients were enteredin one of two trials of anti-emetics to prevent chemotherapy-induced emesis.The QLQ-C30 was completed before chemotherapy and on day 8 after chemotherapy.The factor structure in patients with breast and ovarian cancer was similarto that previously described. Interdomain correlations, in the entire group,were strongest for the physical and role function domains and the fatigue,pain and global quality of life domains before and after chemotherapy.In addition, after chemotherapy, social function was also strongly correlatedwith fatigue and global quality of life. These correlations were not alwaysof equal strength in the breast, ovarian and lung groups, suggesting thatthere may be differences between these groups. The responsiveness of theQLQ-C30 in the presence of widely metastatic, as compared with locoregional,disease showed changes in the expected directions (i.e., diminished functionin physical and social role functions and in global quality of life, withgreater fatigue and pain in patients with metastatic disease). Eight daysafter chemotherapy, decreases were seen in physical, role and social functioningand in global quality of life, and there was greater fatigue, nausea andvomiting compared with before chemotherapy. Patients with breast cancerhad better physical, role and social functioning and less fatigue and painthan patients with ovarian cancer. This result is expected, since manyof the patients with breast cancer had early stage disease, whereas thosewith ovarian cancer had advanced stage disease. Mean scores for patientswith lung cancer were between the other two groups, in keeping with themixture of early and advanced stage disease in these patients. There wasa strong correlation between ECOG performance status scores and severaldomains of the QLQ-C30; these were all in the expected directions. Theresults of this study confirm those in earlier studies on patients withlung cancer, and provide new information on patients with breast and ovariancancer. In addition, the QLQ-C30 is responsive to the effects of chemotherapyand of metastatic disease.

Citation:King MT, Dobson AJ, Harnett PR, A comparison of two quality-of-lifequestionnaires for cancer clinical trials: the functional living index--cancer(FLIC) and the quality of life questionnaire core module (QLQ-C30).,J Clin Epidemiol 49: 1, 21-9, Jan, 1996.
Choosing a measure instrument for a study raises the questionof whether instruments designed for the same purpose produce the same results.We investigated this question for two instruments designed to measure subjectivequality of life (QOL) in cancer clinical trials: the Functional LivingIndex-Cancer (FLIC) and the Quality of Life Questionnaire Core module (QLQ-C30).These were administered concurrently to 98 cancer patients. Four patientgroups were defined: (1) well, no chemotherapy (n = 23); (2) adjuvant chemotherapy(n = 24); (3) stable disease, active chemotherapy (n = 24); (4) progressivedisease (n = 27). Both instruments have global, role, social, emotional,pain, and nausea scales; QLQ-C30 also assesses physical function, cognitivefunction, and fatigue, while FLIC assesses hardship. Correlation analysisindicated convergent validity for the global, role, emotional, pain andnausea dimensions, but not the social dimension. Both instruments indicatedthat groups 1 and 2 had better QOL than group 4 in at least one dimension.However, different dimension-specific results meant that qualitativelydifferent conclusions would have been drawn if either instrument had beenused singly: FLIC indicated that group 1 had better role function thatgroup 4 and suffered less hardship and that group 1 suffered less nauseathan group 3, while the QLQ-C30 data indicated that group 2 had betterphysical function than group 4. The only consistent result was for pain:both instruments indicated group 4 had more pain than either groups 1 or2. Thus the choice of QOL instrument for use in a particular trial willaffect both the results and conclusions. It is important, therefore, toconsider carefully which instrument is most likely to detect importantdifferences relevant to the patients' lives in that setting.

Citation:Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M, The EORTCQLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire(QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group onQuality of Life., Eur J Cancer 30A: 5, 635-42, , 1994.
The EORTC Study Group on Quality of Life has developed amodular system for assessing the quality of life of cancer patients inclinical trials composed of two basic elements: (1) a core quality of lifequestionnaire, the EORTC QLQ-C30, covering general aspects of health-relatedquality of life, and (2) additional disease- or treatment-specific questionnairemodules. Two international field studies were carried out to evaluate thepracticality, reliability and validity of the core questionnaire, supplementedby 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-itemmeasures 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 administeredto patients with non-resectable lung cancer recruited from 17 countries.In total, 883 and 735 patients, respectively, completed the questionnaireprior to and once during treatment. The symptom measures discriminatedclearly between patients differing in performance status. All item scoreschanged significantly in the expected direction (i.e. lung cancer symptomsdecreased and treatment toxicities increased) during treatment. With oneexception (problems with a sore mouth), the change of toxicity measuresover time was related specifically to either chemo- or radiotherapy. However,the single item on neuropathy did not measure adequately the full rangeof symptoms. The hypothesised scale structure of the questionnaire waspartially supported by the data. The multi-item dyspnoea scale met theminimal standards for reliability (Cronbach alpha coefficient > 0.70),while the pain items did not form a scale with reliability estimates acceptablefor group comparisons. In conclusion, the results form international fieldtesting lend support to the EORTC QLQ-LC13 as a clinically valid and usefultool for assessing disease- and treatment-specific symptoms in lung cancerpatients participating in clinical trials, when combined with the EORTCcore quality of life questionnaire. In a few areas, however, the questionnairemodule could benefit from further refinements. In addition, its performanceover a longer period of time still needs to be investigated.

Citation:Maher EJ, Mackenzie C, Young T, Marks D, The use of the HospitalAnxiety and Depression Scale (HADS) and the EORTC QLQ-C30 questionnairesto screen for treatable unmet needs in patients attending routinely forradiotherapy., Cancer Treat Rev 22 Suppl A: 123-9, Jan, 1996.

Citation:Kaasa S, Using quality of life assessment methods in patients withadvanced cancer: a clinical perspective., Eur J Cancer 31A Suppl6: S15-7, , 1995.
The incidence of cancer is expected to increase in most Europeancountries 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 increasedeffort in palliative oncology. Most patients with advanced malignant diseaseshave various unpleasant symptoms which are inadequately treated. In assessingpatients' symptoms and well being, health-related quality of life (HRQL)should be the primary endpoint. Several HRQL instruments have been foundto be valid for use in cancer clinical trials. The EORTC QLQ-C30 is oneamong several cancer-specific HRQL instruments. The QLQ-C30 is composedof nine multi-item scales and six single item measures. This instrumentis developed to be used in conjunction with disease and/or specific modules.

Citation:Niezgoda HE, Pater JL, A validation study of the domains of thecore EORTC quality of life questionnaire., Qual Life Res 2:5, 319-25, Oct, 1993.
A cohort study was conducted to investigate the constructvalidity of the domains of the EORTC QLQ-C30 (European Organization forthe Research and Treatment of Cancer Quality of Life Questionnaire). Ninety-sixpatients undergoing chemotherapy at the Kingston Regional Cancer Centre,Kingston, Canada were given the EORTC QLQ-C30 and two out of four comparisonscales; the Sickness Impact Profile, the McGill Pain Questionnaire, theGeneral Health Questionnaire and the Cancer Rehabilitation Evaluation System,to complete during their clinic visits. Using the multitrait-multimethodmatrix to examine relationships, the Spearman ranked correlation coefficientsof similar and dissimilar domains between the EORTC QLQ-C30 and the comparisonscales were compared. The EORTC QLQ-C30 domains of pain and physical androle functioning performed well in that they converged and diverged appropriatelywith the other instruments. The domain of psychological functioning hadstrong associations with domains thought to be dissimilar (social interactionand fatigue). Social interaction and financial impact diverged across dissimilardomains. This lack of specificity may relate to question wording. The symptomdomain had strong associations with other domains across the comparisonscales. This study shows that the domains of the EORTC QLQ-C30 have substantialconstruct validity in the multidimensional assessment of the quality oflife of cancer patients and identifies where further work is required.

Citation:Kosmidis P, Quality of life as a new end point., Chest 109:5 Suppl, 110S-112S, May, 1996.
Quality of life (QOL) is a relatively new clinical end pointthat is particularly relevant to the typically palliative therapy for non-smallcell lung cancer. Patients' assessments of their QOL are shown to differfrom their physicians', emphasizing the subjective nature of QOL. A numberof relevant instruments and assessment techniques are employed. Resultsfrom a study using the European Organization for Research and Treatmentof Cancer (EORTC) QLQ-C30 instrument before and during chemotherapy arepresented. Some parameters improved while others did not, preventing asimple interpretation. There are arguments for compiling indexes of QOLwhile retaining measures for individual parameters and a desire for theconsistent international use of an instrument such as the EORTC questionnaire.

Citation:Speca M, Robinson JW, Goodey E, Frizzell B, Patients evaluate aquality of life scale: whose life is it anyway?, Cancer Pract 2:5, 365-70, Sep-Oct, 1994.
Patients with cervical cancer were interviewed in a focusgroup format to obtain their retrospective views of quality of life (QL)in the context of cancer treatment. In addition, they were asked to evaluatethe European Organization for Research and Treatment of Cancer's QL questionnaire(EORTC QLQ-C30) as an indicator of their QL. Ethnographic analysis of grouptranscripts revealed a number of dimensions of QL that these women didnot believe were adequately addressed by the EORTC QLQ-C30. They were:(1) perceived control over one's body, (2) a sense of normalcy in one'slife, (3) invasiveness experienced as a result of medical interventions,and (4) the degree of predictability of disease and treatment. Patientsalso indicated that QL was determined more by the meaning and value theyplaced on their experience than by the occurrence of specific functionalchanges, symptoms, or side effects. The results have implications for howQL is conceptualized. An alternative model of QL assessment, based on thepatient as expert, is illustrated and described.

Citation:Wisloff F, Eika S, Hippe E, Hjorth M, Holmberg E, Kaasa S, Palva I,Westin J, Measurement of health-related quality of life in multiplemyeloma. Nordic Myeloma Study Group., Br J Haematol 92: 3, 604-13,Mar, 1996.
When a randomized trial (NMSG 4/90) comparing treatment withmelphalan/prednisone to melphalan/ prednisone + interferon alpha-2b innewly diagnosed multiple myeloma was initiated in 1990, a quality-of-lifeassessment was integrated into the study. We used the questionnaire (QLQ-C30)developed by the European Organization of Research and Treatment of Cancer(EORTC) Study Group on Quality of Life. The QLQ-C30 incorporates five functionalscales, three symptom scales, a global health and quality-of life scaleand some single symptom measures. The questionnaire was completed priorto treatment and after 1, 6, 12, 24, 36 and 48 months. 524 (90.2%) of 581patients enrolled in the NMSG 4/90 completed the first questionnaire, and484 (83.3%) completed all questionnaires given to them. All but one ofthe scales met the minimum criteria of reliability (Cronbach's alpha >/0.70). Validity was shown by (1) the ability of the scales to discriminateclearly between patients differing in clinical status as defined by pretreatmentW.H.O. performance index and Durie & Salmon stage, and (2) the sensitivityto changes in objective disease status (response and relapse). This isthe first report of the measurement of health-related quality of life ina prospective clinical trial in multiple myeloma. The results demonstratethat the QLQ-C30 is a reliable and valid instrument for the measurementof quality of life in these patients. The data will be used for a cost-utilityanalysis of the results of the NMSG 4/90 trial.

Citation:Schaafsma J, Osoba D, The Karnofsky Performance Status Scale re-examined:a cross-validation with the EORTC-C30., Qual Life Res 3: 6,413-24, Dec, 1994.
A cross-validation of the Karnofsky Performance Status (KPS)and quality of life (QOL) as measured by item 30 of the quality of lifequestionnaire developed by the European Organization for Research and Treatmentof Cancer Study Group (EORTC QLQ-C30) was conducted using ordered logitanalysis and prospective data from a continuous sample of 139 lung cancerpatients. The QOL is found to be a much broader concept than the KPS, sinceit likely captures not only physical functioning but also functioning inthe non-physical dimensions of social, emotional, and possibly cognitivewell-being as well as the level of distress in the physical dimensionsof pain, breathing and fatigue. These results suggest that the palliativetreatment of advanced cancer and the terminally ill should be guided bya broad concept of well-being that goes beyond one based only on physicalfunctioning.

Citation:Blazeby JM, Williams MH, Alderson D, Farndon JR, Observer variationin assessment of quality of life in patients with oesophageal cancer.,Br J Surg 82: 9, 1200-3, Sep, 1995.
Quality of life (QOL) assessment may improve the evaluationof treatment for oesophageal cancer but patient compliance using self completionquestionnaires is often poor. The use of a proxy to estimate QOL mightimprove data collection from patients who are either unable or unwillingto complete the questionnaire. This study examined whether a doctor orpatients' carers could accurately assess QOL using the QLQ-C30 questionnairedeveloped by the European Organisation for Research and Treatment of CancerStudy Group on Quality of Life. One doctor, 52 patients and 39 carers completedthe instrument independently. Proxy and patient ratings were analysed foragreement using weighted kappa scores. Agreement was poor or moderate inmost QOL scales and items (kappa < or = 60). This study demonstratesthat a carer or doctor is not sufficiently accurate to postulate the patient'sresponses to the questionnaire. Quality of life data, therefore, shouldcome from the patients themselves.

Citation:Bjordal K, Ahlner-Elmqvist M, Tollesson E, Jensen AB, Razavi D, MaherEJ, Kaasa S, Development of a European Organization for Research andTreatment of Cancer (EORTC) questionnaire module to be used in qualityof life assessments in head and neck cancer patients. EORTC Quality ofLife Study Group., Acta Oncol 33: 8, 879-85, , 1994.
A head and neck cancer specific questionnaire module designedto be used in quality of life assessments before, during, and after radiotherapyand surgery, with or without combinations with chemotherapy has been developedin accordance with guidelines given by the EORTC Quality of Life StudyGroup. Relevant issues were generated by means of literature search, andinterviews with specialists and patients. Pre-testing of a preliminaryquestionnaire module was performed in patients from Norway, Sweden, Denmark,United Kingdom and French-speaking Belgium. The resulting head and neckcancer module, the EORTC QLQ-H&N37, includes 37 items concerning diseaseand treatment related symptoms, social function and sexuality. By usinga combination of the general EORTC QLQ-C30 and the EORTC QLQ-H&N37,health-related quality of life measurements may be compared between studiesin different cancer populations, and still be sensitive to changes in thetarget population.

Citation:Blazeby JM, Williams MH, Brookes ST, Alderson D, Farndon JR, Qualityof life measurement in patients with oesophageal cancer., Gut 37:4, 505-8, Oct, 1995.
Quality of life (QOL) measurement may aid decision makingin the treatment of patients with oesophageal cancer but must be clinicallyvalid to be useful. This study considered if the European Organisationfor Research and Treatment of Cancer QOL questionnaire, the QLQ-C30, showeddiffering results in two clinically distinct groups of patients with oesophagealcancer and also investigated the correlation between dysphagia grade andvarious scales of QOL. Patients treated by oesophagectomy reported significantlybetter physical, emotional, cognitive, and global health scores than thosein the palliative treatment group. Patients who received palliative treatmenthad significantly worse pain, fatigue, appetite loss, constipation, anddysphagia. The correlations between dysphagia grade and each of the QOLscales and items in both groups of patients were poor. This questionnairedifferentiates clearly between the two clinically distinct groups of patients,but to be an entirely appropriate indicator of QOL in patients with oesophagealcancer, an additional specific oesophageal module including a dysphagiascale is required.

Citation:Hjermstad MJ, Fossa SD, Bjordal K, Kaasa S, Test/retest study ofthe European Organization for Research and Treatment of Cancer Core Quality-of-LifeQuestionnaire., J Clin Oncol 13: 5, 1249-54, May, 1995.
PURPOSE: The European Organization for Research and Treatmentof Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validatedinstrument that assesses health-related quality of life (HRQOL) in cancerpatients. It is used in cancer clinical trials in Europe, Canada, and theUnited States, and has demonstrated high reliability and validity in differentgroups of cancer patients. Despite thorough testing of reliability andvalidity, 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 out-patient clinic who were off treatmentfor > or = 3 months were eligible for the study. The EORTC QLQ-C30 wasgiven to the patients when they presented for their visit. The second questionnairewas 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 correlationcoefficient was high for all functional scales, with a range from .82 forcognitive and role function to .91 for physical function. The r value forglobal HRQOL was .85. For the symptom scales--nausea/vomiting, fatigue,and pain--the coefficients were .63, .83, and .86, respectively. The single-itemcoefficients 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 reliabilityin patients with various cancer diagnoses whose condition is not expectedto change during the time of measurement.

Citation:Bjordal K, Freng A, Thorvik J, Kaasa S, Patient self-reported andclinician-rated quality of life in head and neck cancer patients: a cross-sectionalstudy., Eur J Cancer B Oral Oncol 31B: 4, 235-41, Jul, 1995.
One to six years after treatment for head and neck cancer,68 patients were asked to fill in a questionnaire at home with a subsequentexamination at the out-patient clinic of the Ullev al University Hospital.50 patients (74%) both answered the questionnaire (the EORTC QLQ-C30, adiagnosis specific questionnaire module, the GHQ-20, and two questionsfrom a population survey) and presented for examination where the clinicianrated side effects after treatment, and filled in the Karnofsky PerformanceStatus and the Spitzer's Quality of Life index. No patients had relapseor second primary tumours at the time of examination but a variety of post-treatmentside effects were recorded. The patients appeared to report lower qualityof life including more post-treatment side effects compared with the clinician'sassessments. The cost-benefit of the standard clinical follow-ups in termsof increased survival may be questioned. Patients seem to need better supportin coping with the physical and psychosocial problems which often appear.

Citation:Osoba D, Dancey J, Zee B, Myles J, Pater J, Health-related quality-of-lifestudies of the National Cancer Institute of Canada Clinical Trials Group.,J Natl Cancer Inst Monogr 20, 107-11, , 1996.
Since 1989, the National Cancer Institute of Canada ClinicalTrials Group (NCIC CTG) has been successful in implementing and completinghealth-related quality-of-life (HQL) assessments as part of phase III clinicaltrials. Compliance rates for completing HQL instruments remain high, witha minimal amount of missing data. It is believed that this success is attributablenot only to the high degree of commitment to measuring HQL by clinicaltrials investigators, nurses, data managers, and central office administrativestaff, but also to the educational process that was instituted after thedevelopment of a CTG policy for measuring HQL. From inception to May 1995,a total of 27 clinical trials with HQL assessment have been initiated orcompleted. In the majority of trials, the core HQL instrument is the EuropeanOrganization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30). In addition to answering specific questions about HQLin these clinical trials, the trials provide the opportunity to do researchinto the measurement of HQL. Thus, current clinical trials include researchquestions about the appropriate timing of assessments, the reliabilityand validity of the QLQ-C30 and other instruments, the role of HQL datain assessing toxicity, and the significance of the results of HQL assessments.It is anticipated that this activity not only will be a rich source ofinformation about the effects of cancer and its treatment on HQL but alsowill lead to improvements in measuring HQL in oncology.

Citation:Bjordal K, Kaasa S, Psychological distress in head and neck cancerpatients 7-11 years after curative treatment., Br J Cancer 71:3, 592-7, Mar, 1995.
Long-term survivors of head and neck cancer may suffer frompsychological distress and reduced quality of life because of late side-effectsof the treatment. In a follow-up study of patients randomised to two differentradiation fractionating regimens, 204 patients filled in a mailed questionnaire7-11 years after treatment. The questionnaire consisted of the GeneralHealth Questionnaire, 20-item version (GHQ-20), and the EORTC Core Qualityof Life Questionnaire (EORTC QLQ-C30). There were no differences in psychologicaldistress between patients receiving conventional radiotherapy and thosereceiving a slightly hypofractionated regimen. A high prevalence of psychologicaldistress was found in both treatment groups (30% of 'cases' according tothe GHQ-20), especially in patients with impaired cognitive or social function,or with pain. Clinicians need to be aware of this morbidity, and theirability 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 instrumentsfor identification of patients at risk, the clinicians may intervene andhelp the patients to reduce their psychological distress.

Citation:Persson L, Hallberg IR, Acute leukaemia and malignant lymphoma patients'experiences of disease, treatment and nursing care during the active treatmentphase: an explorative study., Eur J Cancer Care (Engl) 4: 3,133-42, Sep, 1995.
Five acute leukaemia or highly malignant lymphoma patientsat a hospital in southern Sweden were interviewed about their daily livingproblems, their coping strategies and their opinions about the nursingcare they received during the active phase of their treatment. In additionthe EORTC QLQ-C30, the Global Life Quality and the Sense of Coherence scaleswere administered. The data were analysed from a hermeneutic phenomenologicalperspective and interpreted to indicate that the patients sensed a threatto their lives, loss of control, and having to live with uncertainty stemmingfrom the disease and the treatment. They had problems with fatigue, diarrhoea,nausea and vomiting, loss of appetite, sore mouth and high temperature.However, they seemed to minimize the importance of these problems and insteadfocused on gaining control of the situation, developing their knowledgeof the disease and relying on the support of their family. Contradictionsappeared in their statements about the quality of care, the informationgiven was said to be good but difficult to understand; although the qualityof the nursing care was judged to be high it had to be asked for. Thatis, help was received on request. The patients' perspective of the familyand the nurses should be studied in further research in order to fullyunderstand the patients' coping strategies and how nursing care can supportthem.

Citation:Sullivan M, [Measuring quality of life. A new general and a newtumor specific formulary for evaluation and planning], Lakartidningen 91: 13, 1340-1, Mar 30, 1994.
The generic measure, SF-36, was developed in the US. It coversboth functioning and well-being and has proved suitable for clinical outcomesresearch, patient monitoring and health care planning. To protect the formsand scoring algorithms of the SF-36 and ensure comparability across studiesand countries the copyright was placed with Medical Outcomes Trust, a non-profitmaking organization. Researchers are granted permission through a useragreement procedure. An international team of investigators is developingauthorized translations of the SF-36 through the International Qualityof Life Assessment (IQOLA) Project, sponsored by Glaxo Research Institute,Research Triangle Park, North Carolina, USA, and Schering-Plough Corporation,Kenilworth, New Jersey, USA. The Swedish test version is currently availableon a case-by-case basis at the Health Care Research Unit. The tumor-specificmeasure, QLQ-C30, was developed and proved reliable in cross-cultural fieldstudies, created by the Quality of Life Study Group within the EuropeanOrganization for Research and Treatment of Cancer (EORTC). It includesquestions on functioning, symptom burden and global quality of life acrosstumors, supplemented by diagnosis--or therapy-specific additional modules.The instrument is copyrighted and all translations are placed with theQuality of Life Unit at the EORTC Data Center, Brussels. Requests for permissionto use the instrument and scoring instructions should be sent to the Center.

Citation:Montazeri A, McEwen J, Gillis CR, Quality of life in patients withovarian cancer: current state of research., Support Care Cancer 4:3, 169-79, May, 1996.
Ovarian cancer is the most malignant cancer in women, whereit is the fifth leading cause of cancer-related death. The disease andits treatment have considerable effects on the quality of life of patientswith this cancer. This study reviews existing literature on quality oflife in patients with ovarian cancer to demonstrate the importance of thetopic, to comment on improvements achieved and to consider their implicationsfor the implementation of optimal treatment. A literature search was carriedout through MEDLINE and of published papers on quality of life in patientswith ovarian cancer from 1976 to 1994. Twenty papers have been reviewed,of which, 10 were treatment-related assessments of quality of life andthe remaining 10 dealt with different topics including psychometric issuesin measuring health-related quality of life. Twenty-four instruments wereemployed to measure quality of life. Of these, the Rotterdam Symptom Checklist(RSCL) and The European Organisation for Research and Treatment of CancerCore Quality of Life Questionnaire (EORTC QLQ-C30) were found to be themost appropriate. Although meta-analysis of results is impossible, it appearsthat debulking surgery followed by platinum-based chemotherapy could improveboth quality of life and survival. In addition to effective and efficienttreatment, psychological counselling, palliative and home care, nutritionalsupport and pain relief are the most important areas for improving qualityof life of patients with ovarian cancer. Knowledge and insight into thequality of life of patients with ovarian cancer are still limited, anda large carefully planned international study is required. Use of existingstandard measures is preferable and agreement should be reached on a selectedsingle instrument.

Citation:Bjordal K, Kaasa S, Mastekaasa A, Quality of life in patients treatedfor head and neck cancer: a follow-up study 7 to 11 years after radiotherapy.,Int J Radiat Oncol Biol Phys 28: 4, 847-56, Mar 1, 1994.
PURPOSE: To compare health-related quality of life factorsin 845 head and neck cancer patients randomized to receive either conventionalradiotherapy (2 Gy, 5 days-a-week) or a hypofractionated regimen (2.35Gy, 4 days-a-week), a follow-up study was carried out 7 to 11 years aftertreatment in the surviving patients, representing 30% of the original patientnumber.

METHODS AND MATERIALS: The cancer-specific EORTC Core Quality of LifeQuestionnaire (30 item version; the EORTC QLQ-C30) and a 19 item head andneck cancer-specific questionnaire were mailed to the 245 surviving patientsof the trial. The EORTC QLQ-C30 is comprised of six multi-item functionscales, three symptom scales, and six single items which assess both symptomsand economic consequences of the disease. Two hundred and four patients(83%) completed the questionnaire. The two groups of patients (N = 103and N = 101) treated by different fractionating schedules, were comparablewith regard to sociodemographic variables, tumor site, treatment variables(including different types of surgical treatment), and secondary primarycancers. Patients in the conventional group had more advanced disease anda higher recurrence rate compared to patients in the hypofractionated group.

RESULTS: Unexpectedly, patients in the hypofractionated group, reportedsimilar or better quality of life compared to patients in the conventionalfractionated group. Patients in both groups described a high level of symptoms,like dryness in the mouth and mucus production. Clinical and sociodemographicvariables did not explain variance in social function, emotional functionor fatigue, except for the type of surgery performed, which significantlyinfluenced the patients' emotional function.

CONCLUSION: Long-term survivors of head and neck cancer reported a highlevel of disease and treatment related symptoms. Emotional function wassignificantly influenced by the type of surgical procedure. Strategiesfor future trials in head and neck cancer should continue to attempt tostress conservative surgical approaches and coordinated adjuvant therapyto maximize local regional control and quality of life. Functional andemotional outcome are important parameters which should prospectively beevaluated in future clinical trials in head and neck cancer.

Citation:Moinpour CM, Measuring quality of life: an emerging science.,Semin Oncol 21: 5 Suppl 10, 48-60; discussion 60-3, Oct, 1994.
Quality of life (QOL) variables are increasingly includedas end points in cancer therapy trials, supplementing such traditionalend points as survival time in evaluating the effects of cancer treatments.Consensus has been reached that a number of QOL components (symptom statusand physical, emotional, role, and social functioning) should be measured.Assessing multiple health-related QOL dimensions, as compared with a globalscore, provides a more detailed accounting of specific effects of cancertreatment on patient functioning. Southwest Oncology Group QOL assessmentpolicies emphasize patient reports and the need for systematic qualitycontrol procedures. The Southwest Oncology Group QOL questionnaire comprisesa battery of categorical scales with established psychometric properties.A set of generic core scales is always included in the battery, and treatment-and disease-specific scales are developed for each trial. Other frequentlyused QOL questionnaires, such as the European Organization for Researchand Treatment of Cancer QLQ-C30, the Cancer Rehabilitation Evaluation Systemquestionnaire, and the Functional Assessment of Cancer Therapy are alternativeinstruments in current use. Quality of life findings from lung cancer clinicaltrials indicate a prevalence of symptom distress, fatigue, and declinein functional status, although patients also experience symptom managementproblems without treatment. A summary of preliminary QOL findings for twovinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park,NC; Pierre Fabre Medicament, Paris, France) trials (randomized and single-arm)in patients with non-small cell lung cancer show that symptom status wasas good or better for patients receiving vinorelbine compared with thosereceiving 5-fluorouracil/leucovorin in the randomized study. Differencesin other QOL dimensions were not detected. Findings for the single-armtrial of oral vinorelbine were generally consistent with those of the randomizedtrial.

Citation:Bamias A, Hill ME, Cunningham D, Norman AR, Ahmed FY, Webb A, WatsonM, Hill AS, Nicolson MC, O'Brien ME, Evans TC, Nicolson V, Epirubicin,cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastricadenocarcinoma: response, toxicity, quality of life, and survival.,Cancer 77: 10, 1978-85, May 15, 1996.
BACKGROUND: The results of chemotherapy for patients withesophagogastric carcinoma have generally been modest but regimens developedmore recently have produced higher response rates, and rekindled interestin neoadjuvant chemotherapy. One such regimen is epirubicin, cisplatin,and 5-fluorouracil (ECF). This study evaluates its efficacy, toxicity,impact on quality of life (QL), and impact on survival in a large consecutiveseries of patients with metastatic and locally advanced disease (LAD).

METHODS: Patients with histologically confirmed esophagogastric carcinomawere treated with ECF (epirubicin 50 mg/m2 and cisplatin 60 mg/m2 every3 weeks with continuous infusion of 5-fluorouracil (5-FU) 200 mg/m2/d).Responses were evaluated with computed tomography (CT) scan and endoscopy.QL was assessed using the European Organization for Research and Treatmentof Cancer QLQ-C30 questionnaire.

RESULTS: A total of 235 patients were treated, 173 with metastatic diseaseand 62 with LAD. The mean number of cycles delivered was 6 (range: 1-11)and patients were followed-up for a median of 8 months. Response was observedin 135 of 220 (61%) evaluable patients, with a complete response (C(R)),11% of the patients and a partial response in 50% of the patients. Patientswith moderately differentiated adenocarcinomas and LAD responded most favorably.Symptomatic improvement was achieved in the majority of cases (63-78% dependingon the symptom). Toxicity was generally only mild to moderate, with severenon hematologic toxicity in less than 12% of the patients and only 6 (2.5%)treatment related deaths. QL assessment showed no significant negativeimpact on emotional functioning and good symptomatic control. Surgery followingresponse to ECF was performed in 29 of the LAD patients, and in 19 cases(66%) a potentially curative resection was possible, with histologic CRin 32% of the patients.

CONCLUSIONS: ECF is a highly active regimen with acceptable toxicityin patients with esophagogastric adenocarcinoma. In a proportion of patientswith LAD, chemotherapy enabled potentially curative surgery to be performed.The results justify further investigation of this regimen in a neoadjuvantsetting.

Citation:Hill M, Norman A, Cunningham D, Findlay M, Watson M, Nicolson V, WebbA, Middleton G, Ahmed F, Hickish T, et al, Impact of protracted venousinfusion fluorouracil with or without interferon alfa-2b on tumor response,survival, and quality of life in advanced colorectal cancer., J ClinOncol 13: 9, 2317-23, Sep, 1995.
PURPOSE: The aim of this study was to investigate the effectsof adding interferon alfa-2b (IFN) to protracted venous infusion fluorouracil(PVI 5-FU) from the start of treatment in patients with advanced colorectalcancer. PATIENTS AND

METHODS: Patients who attended our unit with histologically confirmedadvanced colorectal cancer were randomized to receive either PVI 5-FU 300mg/m2/d via Hickman line, and IFN 5 MU subcutaneously three times weekly,or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks,with a 2-week gap for reassessment of all parameters. Quality of life (QL)was measured by the European Organization for Research and Treatment ofCancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) pretreatmentand every 6 weeks thereafter.

RESULTS: A total of 160 patients were randomized, with 155 eligiblefor assessment. Radiologic response was observed in 43 patients (28%):17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and26 of 78 (33%) in the 5-FU-alone group (complete responses [CRs] and 22PRs) (difference not significant). Symptomatic improvement occurred inthe majority of patients, and equally in both arms: 61% to "80%" dependingon the symptom. There was no significant difference between the two groupsin failure-free survival (median, 161 v 193 days) or overall survival (median,328 v 357 days). However, patients who received IFN did experience significantlymore toxicity in the form of leukopenia (P = .001), neutropenia (P = .04),mucositis (P = .008), and alopecia (P = .0002). There were no toxic deathsand few notable differences in QL between the two arms.

CONCLUSION: This study confirms that PVI 5-FU is effective in treatingthe symptoms associated with metastatic colorectal carcinoma, with onlymild to moderate toxicity and maintenance of QL. IFN 5 MU three times weeklydoes not enhance these palliative benefits.

Citation:Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, FilibertiA, Flechtner H, Fleishman SB, de Haes JC, et al, The European Organizationfor Research and Treatment of Cancer QLQ-C30: a quality-of-life instrumentfor use in international clinical trials in oncology., J Natl CancerInst 85: 5, 365-76, Mar 3, 1993.
BACKGROUND: In 1986, the European Organization for Researchand Treatment of Cancer (EORTC) initiated a research program to developan integrated, modular approach for evaluating the quality of life of patientsparticipating in international clinical trials. PURPOSE: We report herethe results of an international field study of the practicality, reliability,and validity of the EORTC QLQ-C30, the current core questionnaire. TheQLQ-C30 incorporates nine multi-item scales: five functional scales (physical,role, cognitive, emotional, and social); three symptom scales (fatigue,pain, and nausea and vomiting); and a global health and quality-of-lifescale. Several single-item symptom measures are also included.

METHODS: The questionnaire was administered before treatment and onceduring treatment to 305 patients with nonresectable lung cancer from centersin 13 countries. Clinical variables assessed included disease stage, weightloss, performance status, and treatment toxicity.

RESULTS: The average time required to complete the questionnaire wasapproximately 11 minutes, and most patients required no assistance. Thedata supported the hypothesized scale structure of the questionnaire withthe exception of role functioning (work and household activities), whichwas also the only multi-item scale that failed to meet the minimal standardsfor reliability (Cronbach's alpha coefficient > or = .70) either beforeor during treatment. Validity was shown by three findings. First, whileall interscale correlations were statistically significant, the correlationwas moderate, indicating that the scales were assessing distinct componentsof the quality-of-life construct. Second, most of the functional and symptommeasures discriminated clearly between patients differing in clinical statusas defined by the Eastern Cooperative Oncology Group performance statusscale, weight loss, and treatment toxicity. Third, there were statisticallysignificant changes, in the expected direction, in physical and role functioning,global quality of life, fatigue, and nausea and vomiting, for patientswhose performance status had improved or worsened during treatment. Thereliability and validity of the questionnaire were highly consistent acrossthe three language-cultural groups studied: patients from English-speakingcountries, Northern Europe, and Southern Europe.

CONCLUSIONS: These results support the EORTC QLQ-C30 as a reliable andvalid measure of the quality of life of cancer patients in multiculturalclinical research settings. Work is ongoing to examine the performanceof the questionnaire among more heterogenous patient samples and in phaseII and phase III clinical trials.

Citation:Ringdal GI, Ringdal K, Testing the EORTC Quality of Life Questionnaireon cancer patients with heterogeneous diagnoses., Qual Life Res 2:2, 129-40, Apr, 1993.
This study aimed to contribute to the validation of the 30-itemQuality of Life Questionnaire developed by the European Organization forResearch and Treatment of Cancer Study Group (EORTC QLQ-C30). The sampleconsisted of 177 cancer patients with heterogeneous diagnoses. A seriesof scales representing various dimensions of quality of life were tested,including those proposed by the EORTC Study Group. Mokken's non-parametriclatent trait model for unidimensional scaling was used as the basic scalingprocedure. This model gives coefficients of scalability in addition toreliability coefficients. In terms of scalability measured by Loevinger'sH, all EORTC Study Group scales, except the cognitive functioning scalewere found to be quite satisfactory. The cognitive functioning scale andthe role functioning scale were below the satisfactory level in terms ofreliability (internal consistency). In total, our study strengthens theexternal validity of the EORTC QLQ-C30 and confirms that it may be usedon cancer patients with various diagnoses.

Citation:Sprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK, The EuropeanOrganization for Research and Treatment of Cancer. Approach to qualityof life assessment: guidelines for developing questionnaire modules. EORTCStudy Group on Quality of Life., Qual Life Res 2: 4, 287-95,Aug, 1993.
The EORTC Study Group on Quality of Life (the Study Group)has adopted a modular approach to quality of life (QOL) assessment in cancerclinical trials. A 'core' instrument-the QLQ-C30-has been designed to covera range of QOL issues relevant to a broad spectrum of cancer patients.It is intended that this QLQ-C30 be supplemented by more specific subscales('modules') to assess aspects of QOL of particular importance to specificsubgroups of patients. Since individual members of the Study Group wereto be involved in module development, guidelines were required to standardizethe module development process in order to ensure uniformly high qualityacross modules. These guidelines are presented in this paper. The term'module' is defined, the composition of modules is outlined, and the criteriaused to develop modules are specified. The module development process,consisting of four phases (generation of relevant QOL issues, operationalizationof the QOL issues into a set of items, pretesting the module questionnaire,and large-scale field-testing) is described in detail. Further, issuesrelated to cross-cultural instrument development, and the need for monitoringthe module development process from within the Study Group are discussed.Finally, experiences with developing two site-specific modules (i.e., forhead and neck, and breast cancer), are presented and the extent to whichthe guidelines meet practical requirements is discussed. The guidelinesappear to provide a practical tool for module construction, that can facilitatethe development of a comprehensive system for assessing the QOL of cancerpatients internationally.

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