Quality-of-Life Assessment in Cancer Treatment Protocols: Research Issues in Protocol Development

Publication Type
Journal Article
Year of Publication
1992
Authors
Gotay, C C; Korn, E L; McCabe, M S; Moore, T D; Cheson, B D
Secondary
J Natl Cancer Inst
Volume
84
Start Page
575
Pagination
575-579
Date Published
04/1992
Keywords
Clinical Protocols; Humans; Neoplasms; quality of life; Survival Analysis
Abstract

BACKGROUND: Interest in incorporating quality of life as an end point in clinical studies of cancer treatment has intensified in recent years.

PURPOSE: We provide practical suggestions that will assist investigators considering including quality-of-life assessment in phase III therapeutic trials.

METHODS: We discuss issues important in study planning, including quality-of-life definition, priority studies for quality-of-life assessment, eligibility requirements, and design.

CONCLUSIONS: Many of the problems that quality-of-life studies have encountered, from protocol approval to data analysis, could be addressed and alleviated during protocol development. This discussion is intended to assist and stimulate investigators conducting research in this area.