Health-related quality-of-life studies of the National Cancer Institute of Canada Clinical Trials Group. 1996

D Osoba, and J Dancey, and B Zee, and J Myles, and J Pater
British Columbia Cancer Agency, Vancouver, Canada.

Since 1989, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) has been successful in implementing and completing health-related quality-of-life (HQL) assessments as part of phase III clinical trials. Compliance rates for completing HQL instruments remain high, with a minimal amount of missing data. It is believed that this success is attributable not only to the high degree of commitment to measuring HQL by clinical trials investigators, nurses, data managers, and central office administrative staff, but also to the educational process that was instituted after the development of a CTG policy for measuring HQL. From inception to May 1995, a total of 27 clinical trials with HQL assessment have been initiated or completed. In the majority of trials, the core HQL instrument is the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). In addition to answering specific questions about HQL in these clinical trials, the trials provide the opportunity to do research into the measurement of HQL. Thus, current clinical trials include research questions about the appropriate timing of assessments, the reliability and validity of the QLQ-C30 and other instruments, the role of HQL data in assessing toxicity, and the significance of the results of HQL assessments. It is anticipated that this activity not only will be a rich source of information about the effects of cancer and its treatment on HQL but also will lead to improvements in measuring HQL in oncology.

UI MeSH Term Description Entries
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D002170 Canada The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D017326 Clinical Trials, Phase III as Topic Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries. Clinical Trials, Phase 3 as Topic,Drug Evaluation, FDA Phase 3 as Topic,Drug Evaluation, FDA Phase III as Topic,Evaluation Studies, FDA Phase 3 as Topic,Evaluation Studies, FDA Phase III as Topic

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