© 1993 by Oxford University Press
Journal of the National Cancer Institute, Vol. 85, No. 5, 365-376,
March 3, 1993
© 1993 Oxford University Press
The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute Amsterdam
The Leicestershire Hospice Leicester, England
Renstromska Hospital Göteborg, Sweden
Biometric Center for Therapeutic Studies, Munich Federal Republic of Germany (FRG)
Imperial Cancer Research Fund (ICRF) Medical Oncology Unit Edinburgh, Scotland
EORTC Central Office and Data Center Brussels, Belgium
Istituto Nazionale Tumori Milan, Italy
University of Cologne, FRG
Long Island Jewish Medical Cente New Hyde Park, N.Y. (for the Cancer and Leukemia Group B)
Academic Medical Center, University of Amsterdam The Netherlands
The Norwegian Radium Hospital Oslo, Norway
Rigshospitalet, Copenhagen Denmark
British Columbia Cancer Agency Vancouver, Canada
Institut Jules Bordet Brussels, Belgium
Royal Adelaide Hospital Adelaide, South Australia
Centre Hospitalier Régional de Besancon France
The Netherlands Cancer Institute
Sahlgrenska Hospital Göteborg, Sweden
Saitama Cancer Center Japan
Correspondence to: Neil K. Aaronson, Ph.D., Division of Psychosocial Research and Epidemiology. The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.
Background: In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. Purpose: We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-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-life scale. Several single-item symptom measures are also included. Methods: The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. Results: The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient >.70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. Conclusions: These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials. [J Natl Cancer Inst 85: 365-376, 1993]
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A. Bottomley, C. Coens, F. Efficace, R. Gaafar, C. Manegold, S. Burgers, M. Vincent, C. Legrand, and J. P. van Meerbeeck Symptoms and Patient-Reported Well-Being: Do They Predict Survival in Malignant Pleural Mesothelioma? A Prognostic Factor Analysis of EORTC-NCIC 08983: Randomized Phase III Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma J. Clin. Oncol., December 20, 2007; 25(36): 5770 - 5776. [Abstract] [Full Text] [PDF] |
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P. Pommier, S. Chabaud, J. L. Lagrange, P. Richaud, F. Lesaunier, E. Le Prise, J. P. Wagner, M. H. Hay, V. Beckendorf, J. P. Suchaud, et al. Is There a Role for Pelvic Irradiation in Localized Prostate Adenocarcinoma? Preliminary Results of GETUG-01 J. Clin. Oncol., December 1, 2007; 25(34): 5366 - 5373. [Abstract] [Full Text] [PDF] |
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C. Tishelman, L.-M. Petersson, L. F. Degner, and M. A.G. Sprangers Symptom Prevalence, Intensity, and Distress in Patients With Inoperable Lung Cancer in Relation to Time of Death J. Clin. Oncol., December 1, 2007; 25(34): 5381 - 5389. [Abstract] [Full Text] [PDF] |
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F. Joly, J. Vardy, M. Pintilie, and I. F. Tannock Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer Ann. Onc., December 1, 2007; 18(12): 1935 - 1942. [Abstract] [Full Text] [PDF] |
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J. O. Park, S.-W. Kim, J. S. Ahn, C. Suh, J. S. Lee, J. S. Jang, E. K. Cho, S. H. Yang, J.-H. Choi, D. S. Heo, et al. Phase III Trial of Two Versus Four Additional Cycles in Patients Who Are Nonprogressive After Two Cycles of Platinum-Based Chemotherapy in Non Small-Cell Lung Cancer J. Clin. Oncol., November 20, 2007; 25(33): 5233 - 5239. [Abstract] [Full Text] [PDF] |
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D. J. Jonker, C. J. O'Callaghan, C. S. Karapetis, J. R. Zalcberg, D. Tu, H.-J. Au, S. R. Berry, M. Krahn, T. Price, R. J. Simes, et al. Cetuximab for the Treatment of Colorectal Cancer N. Engl. J. Med., November 15, 2007; 357(20): 2040 - 2048. [Abstract] [Full Text] [PDF] |
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D. Watkins Bruner, C. J. Bryan, N. Aaronson, C. C. Blackmore, M. Brundage, D. Cella, P. A. Ganz, C. Gotay, P. S. Hinds, A. B. Kornblith, et al. Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute Sponsored Clinical Trials Networks J. Clin. Oncol., November 10, 2007; 25(32): 5051 - 5057. [Abstract] [Full Text] [PDF] |
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M. Brundage, D. Osoba, A. Bezjak, D. Tu, M. Palmer, and J. Pater Lessons Learned in the Assessment of Health-Related Quality of Life: Selected Examples From the National Cancer Institute of Canada Clinical Trials Group J. Clin. Oncol., November 10, 2007; 25(32): 5078 - 5081. [Abstract] [Full Text] [PDF] |
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A. Bottomley and N. K. Aaronson International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience J. Clin. Oncol., November 10, 2007; 25(32): 5082 - 5086. [Abstract] [Full Text] [PDF] |
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R. V. Iyer, J. Gibbs, B. Kuvshinoff, M. Fakih, J. Kepner, N. Soehnlein, D. Lawrence, and M. M. Javle A Phase II Study of Gemcitabine and Capecitabine in Advanced Cholangiocarcinoma and Carcinoma of the Gallbladder: A Single-Institution Prospective Study Ann. Surg. Oncol., November 1, 2007; 14(11): 3202 - 3209. [Abstract] [Full Text] [PDF] |
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D. J. Storey, R. A. Waters, C. J. Hibberd, R. W. Rush, A. T. Cargill, L. R. Wall, M. T. Fallon, V. A. Strong, J. Walker, and M. Sharpe Clinically relevant fatigue in cancer outpatients: the Edinburgh Cancer Centre symptom study Ann. Onc., November 1, 2007; 18(11): 1861 - 1869. [Abstract] [Full Text] [PDF] |
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D. Osoba Translating the Science of Patient-Reported Outcomes Assessment Into Clinical Practice J Natl Cancer Inst Monographs, October 1, 2007; 2007(37): 5 - 11. [Abstract] [Full Text] [PDF] |
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C. E. Ferrans Differences in What Quality-of-Life Instruments Measure J Natl Cancer Inst Monographs, October 1, 2007; 2007(37): 22 - 26. [Abstract] [Full Text] [PDF] |
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C. M. Moinpour, G. W. Donaldson, and M. W. Redman Do General Dimensions of Quality of Life Add Clinical Value to Symptom Data? J Natl Cancer Inst Monographs, October 1, 2007; 2007(37): 31 - 38. [Abstract] [Full Text] [PDF] |
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D. Cella, L. Wagner, J. Cashy, T. A. Hensing, S. Yount, and R. C. Lilenbaum Should Health-Related Quality of Life Be Measured in Cancer Symptom Management Clinical Trials? Lessons Learned Using the Functional Assessment of Cancer Therapy J Natl Cancer Inst Monographs, October 1, 2007; 2007(37): 53 - 60. [Abstract] [Full Text] [PDF] |
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K. S. Bull, H. A. Spoudeas, G. Yadegarfar, and C. R. Kennedy Reduction of Health Status 7 Years After Addition of Chemotherapy to Craniospinal Irradiation for Medulloblastoma: A Follow-Up Study in PNET 3 Trial Survivors on Behalf of the CCLG (formerly UKCCSG) J. Clin. Oncol., September 20, 2007; 25(27): 4239 - 4245. [Abstract] [Full Text] [PDF] |
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A. M. Arnold, L. Seymour, M. Smylie, K. Ding, Y. Ung, B. Findlay, C. W. Lee, M. Djurfeldt, M. Whitehead, P. Ellis, et al. Phase II Study of Vandetanib or Placebo in Small-Cell Lung Cancer Patients After Complete or Partial Response to Induction Chemotherapy With or Without Radiation Therapy: National Cancer Institute of Canada Clinical Trials Group Study BR.20 J. Clin. Oncol., September 20, 2007; 25(27): 4278 - 4284. [Abstract] [Full Text] [PDF] |
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E. J. Pearson, J. G Todd, and J. M Futcher How can occupational therapists measure outcomes in palliative care? Palliative Medicine, September 1, 2007; 21(6): 477 - 485. [Abstract] [PDF] |
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J. Lipscomb, C. C. Gotay, and C. F. Snyder Patient-reported Outcomes in Cancer: A Review of Recent Research and Policy Initiatives CA Cancer J Clin, September 1, 2007; 57(5): 278 - 300. [Abstract] [Full Text] [PDF] |
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J. A. Ajani, V. M. Moiseyenko, S. Tjulandin, A. Majlis, M. Constenla, C. Boni, A. Rodrigues, M. Fodor, Y. Chao, E. Voznyi, et al. Quality of Life With Docetaxel Plus Cisplatin and Fluorouracil Compared With Cisplatin and Fluorouracil From a Phase III Trial for Advanced Gastric or Gastroesophageal Adenocarcinoma: The V-325 Study Group J. Clin. Oncol., August 1, 2007; 25(22): 3210 - 3216. [Abstract] [Full Text] [PDF] |
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A. D. Roth, N. Fazio, R. Stupp, S. Falk, J. Bernhard, P. Saletti, D. Koberle, M. M. Borner, K. Rufibach, R. Maibach, et al. Docetaxel, Cisplatin, and Fluorouracil; Docetaxel and Cisplatin; and Epirubicin, Cisplatin, and Fluorouracil As Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial of the Swiss Group for Clinical Cancer Research J. Clin. Oncol., August 1, 2007; 25(22): 3217 - 3223. [Abstract] [Full Text] [PDF] |
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A. M. Easson, A. Bezjak, S. Ross, and J. G. Wright The Ability of Existing Questionnaires to Measure Symptom Change After Paracentesis for Symptomatic Ascites Ann. Surg. Oncol., August 1, 2007; 14(8): 2348 - 2357. [Abstract] [Full Text] [PDF] |
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B Sirohi, R Powles, D Lawrence, J Treleaven, S Kulkarni, A Leary, C Rudin, C Horton, and G Morgan An open, randomized, controlled, phase II, single centre, two-period cross-over study to compare the quality of life and toxicity experienced on PEG interferon with interferon-{alpha}2b in patients with multiple myeloma maintained on a steady dose of interferon-{alpha}2b Ann. Onc., August 1, 2007; 18(8): 1388 - 1394. [Abstract] [Full Text] [PDF] |
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D. G. Jayne, P. J. Guillou, H. Thorpe, P. Quirke, J. Copeland, A. M.H. Smith, R. M. Heath, and J. M. Brown Randomized Trial of Laparoscopic-Assisted Resection of Colorectal Carcinoma: 3-Year Results of the UK MRC CLASICC Trial Group J. Clin. Oncol., July 20, 2007; 25(21): 3061 - 3068. [Abstract] [Full Text] [PDF] |
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T. Kuchler, B. Bestmann, S. Rappat, D. Henne-Bruns, and S. Wood-Dauphinee Impact of Psychotherapeutic Support for Patients With Gastrointestinal Cancer Undergoing Surgery: 10-Year Survival Results of a Randomized Trial J. Clin. Oncol., July 1, 2007; 25(19): 2702 - 2708. [Abstract] [Full Text] [PDF] |
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C. Saxby, R. Ackroyd, S. Callin, C. Mayland, and S. Kite How should we measure emesis in palliative care? Palliative Medicine, July 1, 2007; 21(5): 369 - 383. [Abstract] [PDF] |
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B. H.P. Osse, M. J.F.J. Vernooij-Dassen, E. Schade, and R. P.T.M. Grol A practical instrument to explore patients' needs in palliative care: the Problems and Needs in Palliative Care questionnaire short version Palliative Medicine, July 1, 2007; 21(5): 391 - 399. [Abstract] [PDF] |
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S H Kim, S K u, Y H Yun, C G Lee, Y S Choi, W S Lee, S Y Kim, and D S Heo Validation study of the Korean version of the McGill Quality of Life Questionnaire Palliative Medicine, July 1, 2007; 21(5): 441 - 447. [Abstract] [PDF] |
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J. A. Cornish, H. S. Tilney, A. G. Heriot, I. C. Lavery, V. W. Fazio, and P. P. Tekkis A Meta-Analysis of Quality of Life for Abdominoperineal Excision of Rectum versus Anterior Resection for Rectal Cancer Ann. Surg. Oncol., July 1, 2007; 14(7): 2056 - 2068. [Abstract] [Full Text] [PDF] |
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