Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients

Annals of Oncology

Volumn 24, Issue 1, 2013, Pages 231-237

  Ediebah, D E ^a   Coens, C ^a   Maringwa, J T ^b   Quinten, C ^a   Zikos, E ^a   Ringash, J ^c   King, M ^d   Gotay, C ^e   Flechtner, H H ^f   Schmucker von Koch, J ^g   Weis, J ^h   Smit, E F ⁱ   Kohne C H ^j   Bottomley, A ^a  

^a EORTC DATA CENTER   (Belgium)

^b Quantitative Solutions BV   (Belgium)

^c UNIVERSITY OF TORONTO   (Canada)

^d UNIVERSITY OF SYDNEY   (Australia)

^e UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^f OTTO VON GUERICKE UNIVERSITY   (Germany)

^g UNIVERSITY OF REGENSBURG   (Germany)

^h UNIVERSITY OF FREIBURG   (Germany)

ⁱ VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^j KLINIKUM OLDENBURG   (Germany)

more..

Author keywords

Cancer clinical trial; Completion time window; Health related quality of life; Quality of lie

Indexed keywords

CISPLATIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; PACLITAXEL;

ARTICLE; CANCER PATIENT; COGNITION; COLORECTAL CANCER; COMPLETION TIME WINDOW; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG DOSE REDUCTION; DYSPNEA; EMOTION; FATIGUE; FINANCIAL DEFICIT; HEALTH STATUS; HUMAN; INSOMNIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; NAUSEA; PAIN; PHASE 3 CLINICAL TRIAL; PHYSICAL PERFORMANCE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SOCIAL STATUS; STATISTICAL ANALYSIS; VOMITING;

EID: 84871605557     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds220     Document Type: Article

References (33)

1. Fairclough DL. Design and Analysis of Quality of Life Studies in the Clinical Trials. London: Chapman and hall/CRC 2002.
2. Osoba D. Rationale for the timing of health-related quality-of-life (HQL) assessments in oncological palliative therapy. Cancer Treat Rev 1996; 22: 69-73.
3. Klee MC, King MT, Machin D et al. A clinical model for quality of life assessment in cancer patients receiving chemotherapy. Ann Oncol 2000; 11(1): 23-30.
4. Hopwood P, Stephens RJ, Machin D. Approaches to the analysis of quality of life data: experiences gained from a medical research council lung cancer working party palliative chemotherapy trial. Qual Life Res. 1994; 3(5): 339-352.
5. Hürny C, Bernhard J, Coates A et al. The International Breast Cancer Study Group: timing of baseline quality of life assessment in an international adjuvant breast cancer trial: its effect on patient self-estimation. Ann Oncol 1994; 5: 65-74.
6. Pater J, Osoba D, Zee B et al. Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial. Qual Life Res 1998; 7: 273-278.
7. Smit EF, van Meerbeeck JPAM, Lianes P et al. Three-arm randomised study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced nonsmall cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 2003; 21: 3909-3917.
8. Köhne C-H, van Cutsem E, Wils J et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol 2005; 23(22): 4856-4865.
9. Köhne CH, Wils J, Lorenz M et al. Randomised phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer: European Organization of Research and Treatment of Cancer Gastrointestinal Group Study 40952. J Clin Oncol 2003; 21(20): 3721-3728.
10. Aaronson NK, Ahmedzai S, Bullinger M et al. The EORTC core quality-of-life questionnaire: interim results of an international field study. In Osoba D (ed), Effect of Cancer on Quality of Life. Boston: CRC Press 1991; 185-203.
11. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365-376.
12. Groenvold M, Klee MC, Sprangers MA et al. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol 1997; 50: 441-450.
13. Hjermstad MJ, Fossa SD, Bjordal K et al. Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire. J Clin Oncol 1995; 13: 1249-1254.
14. Bjordal K, Kaasa S. Psychometric validation of the EORTC core quality of life questionnaire, 30-item version and a diagnosis-specific module for head and neck cancer patients. Acta Oncol 1992; 31: 311-321.
15. Ringdal GI, Ringdal K. Testing the EORTC Quality of Life Questionnaire on cancer patients with heterogeneous diagnoses. Quality Life Res 1993; 2: 129-140.
16. Fayers PM, Aaronson NK, Bjordal K et al. on behalf of the EORTC Quality of Life Group. EORTC QLQ-C30 Scoring Manual, 3rd edition. Brussels, EORTC 2001.
17. Osoba D, Zee B, Pater J et al. Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res 1994; 3(5): 353-364.
18. Uwer L, Rotonda C, Guillemin F et al. Responsiveness of EORTC QLQ-C30, QLQCR38 and FACT-C quality of life questionnaires in patients with colorectal cancer. Health Qual Life Outcomes 2011; 9: 70.
19. Osoba D, Rodrigues G, Myles J et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16: 139-144.
20. Ringash J, Redelmeier DA, O'Sullivan B et al. Quality of life and utility in irradiated laryngeal cancer patients. Int J Radiat Oncol Biol Phys 2000; 47(4): 875-881.
21. Verbeke, G, Molenberghs G. Linear Mixed Models for Longitudinal Data. New York: Springer-Verlag 2000.
22. Akaike H. "Information theory and an extension of the maximum likelihood principle". In Petrov BN, Csaki F (eds), Second International Symposium on Information Theory. Budapest: Akademiai Kiado 1973; 267-281.
23. Schwarz, G. "Estimating the dimension of a model". Ann Stat 1978; 6: 461-464.
24. Bottomley A, Therasse P, Piccart M et al. Health-related quality of life in survivors of locally advanced breast cancer: an international randomised controlled phase III trial. Lancet Oncol 2005; 6: 287-294.
25. Fayers P, Aaronson N, Bjordal K et al. on behalf of EORTC Quality of Life Study Group. EORTC QLQ-C30 Scoring Manual. EORTC Study Group on Quality of Life. Brussels, Belgium: EORTC Data Centre 1995.
26. Bergman B, Sullivan M, SÖrenson S. Quality of life during chemotherapy for small cell lung cancer. I. An evaluation with generic health measures. Acta Oncol 1991; 30: 947-957.
27. Sigurdadóttir V, Bolund C, Sullivan M. Quality of life evaluation by the EORTC questionnaire technique in patients with generalized malignant melanoma on chemotherapy. Acta Oncol 1996; 35: 149-159.
28. Curran D, Fossa S, Aaronson N et al. Baseline quality of life of patients with advanced prostate cancer. Eur J Cancer 1997; 33: 1809-1814.
29. Ballatori E, Roila F. Impact of nausea and vomiting on quality of life in cancer patients during chemotherapy. Health Qual Life Outcomes 2003; 1: 46.
30. SAS Institute Inc. 2010. SAS/GRAPH® 9.2 Reference, 2nd Edition. Cary, NC: SAS Institute Inc.
31. Scott NW, Fayers P, Bottomley A et al. EORTC QLQ-C30 Reference Values Manual. Brussels, Belgium: EORTC Quality of Life Group Publications 2008.
32. Fairclough DL. Summary measures and statistics for comparison of quality of life in a clinical trial of cancer therapy. Stat Med 1997; 15: 1197-1209.
33. Curran D, Aaronson N, Standaert B et al. Summary measures and statistics in the analysis of quality of life data: an example from an EORTCNCIC-SAKK locally advanced breast cancer study. Eur J Cancer 2000; 36: 834-844.