PURPOSE: The main purpose of this paper is to present the results of a randomized trial comparing the effects of two chemotherapy regimens on the Quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC). Trials in advanced stage disease represent an important treatment context for QOL assessment. A second purpose of this paper is to examine methods for handling the level of missing data commonly observed in the advanced stage disease context. METHODS: Patients were randomized to receive cisplatin plus vinorelbine or carboplatin plus paclitaxel. The QOL of 222 patients was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) prior to randomization; follow-up assessments occurred at 13 and 25 weeks. Three methods were used to analyze the QOL data: (1) cross-sectional analysis of four patient categories (improved, stable, missing, and declined) based on changes in the FACT-L score, (2) a mixed linear model, and (3) a pattern mixture model. The longitudinal analyses addressed two potential data biases. RESULTS:Questionnaire submission rates were 91% at baseline, 68% at 13 weeks, and 47% at 25 weeks. The cross-sectional and mixed linear model analyses did not show significant differences by treatment arm in patient-reported QOL. The pattern mixture model analysis, more appropriate given non-ignorable missing data, also found no statistically significant effect of treatment on patient QOL. CONCLUSION: We present a sensitivity analysis approach with multiple methods for analyzing treatment effects on patient QOL in the presence of substantial, non-ignorable missing data in an advanced stage disease clinical trial. We conclude that the two treatment arms did not differ statistically in their effects on patient QOL over a 25-week treatment period.
RCT Entities:
PURPOSE: The main purpose of this paper is to present the results of a randomized trial comparing the effects of two chemotherapy regimens on the Quality of life (QOL) of patients with advanced non-small-cell lung cancer (NSCLC). Trials in advanced stage disease represent an important treatment context for QOL assessment. A second purpose of this paper is to examine methods for handling the level of missing data commonly observed in the advanced stage disease context. METHODS:Patients were randomized to receive cisplatin plus vinorelbine or carboplatin plus paclitaxel. The QOL of 222 patients was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) prior to randomization; follow-up assessments occurred at 13 and 25 weeks. Three methods were used to analyze the QOL data: (1) cross-sectional analysis of four patient categories (improved, stable, missing, and declined) based on changes in the FACT-L score, (2) a mixed linear model, and (3) a pattern mixture model. The longitudinal analyses addressed two potential data biases. RESULTS: Questionnaire submission rates were 91% at baseline, 68% at 13 weeks, and 47% at 25 weeks. The cross-sectional and mixed linear model analyses did not show significant differences by treatment arm in patient-reported QOL. The pattern mixture model analysis, more appropriate given non-ignorable missing data, also found no statistically significant effect of treatment on patient QOL. CONCLUSION: We present a sensitivity analysis approach with multiple methods for analyzing treatment effects on patient QOL in the presence of substantial, non-ignorable missing data in an advanced stage disease clinical trial. We conclude that the two treatment arms did not differ statistically in their effects on patient QOL over a 25-week treatment period.
Authors: K Kelly; J Crowley; P A Bunn; C A Presant; P K Grevstad; C M Moinpour; S D Ramsey; A J Wozniak; G R Weiss; D F Moore; V K Israel; R B Livingston; D R Gandara Journal: J Clin Oncol Date: 2001-07-01 Impact factor: 44.544
Authors: M P Kosty; S B Fleishman; J E Herndon; K Coughlin; A B Kornblith; A Scalzo; J C Morris; J Mortimer; M R Green Journal: J Clin Oncol Date: 1994-06 Impact factor: 44.544
Authors: A J Wozniak; J J Crowley; S P Balcerzak; G R Weiss; C H Spiridonidis; L H Baker; K S Albain; K Kelly; S A Taylor; D R Gandara; R B Livingston Journal: J Clin Oncol Date: 1998-07 Impact factor: 44.544
Authors: Jeff A Sloan; Marlene H Frost; Rick Berzon; Amylou Dueck; Gordon Guyatt; Carol Moinpour; Mirjam Sprangers; Carol Ferrans; David Cella Journal: Support Care Cancer Date: 2006-06-23 Impact factor: 3.603
Authors: Pamela J Atherton; Deborah W Watkins-Bruner; Carolyn Gotay; Carol M Moinpour; Daniel V Satele; Kathryn A Winter; Paul L Schaefer; Benjamin Movsas; Jeff A Sloan Journal: J Pain Symptom Manage Date: 2015-05-30 Impact factor: 3.612