Assessment and Analysis of QOL Outcomes in Cancer Clinical Trials: The NSABP Experience

• Activity Number: 59
• Type: Invited
• Date/Time: Monday, August 12, 2002 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Stephanie Land*+ and Jacek Kopec and Greg Yothers and Stewart Anderson and Gong Tang and Patricia Ganz and Bernard Fisher and Norman Wolmark
• Affiliation(s): University of Pittsburgh and University of British Columbia and University of Pittsburgh and University of Pittsburgh and University of Pittsburgh and University of California, Los Angeles and National Surgical Adjuvant Breast and Bowel Project and National Surgical Adjuvant Breast and Bowel Project
• Keywords: clinical trial ; compliance ; chemotherapy

Abstract

This presentation will focus on some of the issues that arise with quality of life (QOL) assessment in large multi-center cancer clinical trials. The context will be a QOL study that was a component of a breast cancer chemotherapy trial (Protocol B-23) performed by the National Surgical Adjuvant Breast and Bowel Project (NSABP). One difficulty with the analysis in this trial is that the timing and duration of therapy was different in the two treatment arms, so that the timing of the quality of life assessments was also different in the two treatment arms. Analytic approaches to allow for these differences will be presented. A second major difficulty with assessment and analysis was a large proportion of missing data. The NSABP effort to develop a suite of statistical methods for the analysis of missing QOL data will be briefly described. More emphasis will be given to methods to improve compliance in ongoing clinical trials.