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Health-related quality-of-life findings for the prostate cancer prevention trial
Quantitative Health Sciences Publications and Presentations
  • Carol M. Moinpour, Fred Hutchinson Cancer Research Center
  • Amy K. Darke, Fred Hutchinson Cancer Research Center
  • Gary W. Donaldson, University of Utah
  • Duane Cespedes, Shore Comprehensive Urology
  • Christine R. Johnson, Brooke Army Medical Center
  • Patricia A. Ganz, University of California
  • Donald L. Patrick, University of Washington
  • John E. Ware, Jr., University of Massachusetts Medical School
  • Sally A. Shumaker, Wake Forest University School of Medicine
  • Frank L. Meyskens, University of California
  • Ian M. Thompson, Jr., University of Texas Health Sciences Center
UMMS Affiliation
Department of Quantitative Health Sciences
Publication Date
9-19-2012
Document Type
Article
Subjects
Quality of Life; Health Status; Prostatic Neoplasms
Abstract
BACKGROUND: The Prostate Cancer Prevention Trial (PCPT)-a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer-offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. METHODS: We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form-36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided. RESULTS: For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = -0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = -5.64, 95% CI = -7.96 to -3.32, P < .001), leg pain (estimate = -2.57, 95% CI = -3.04 to -2.10, P < .001), and diabetes (estimate = -1.31, 95% CI = -2.04 to -0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = -2.34, 95% CI = -2.97 to -1.71, P < .001) and time on study (estimate = -1.20, 95% CI = -1.36 to -1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points. CONCLUSION: Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.
DOI of Published Version
10.1093/jnci/djs359
Source
J Natl Cancer Inst. 2012 Sep 19;104(18):1373-85. Epub 2012 Sep 12. Link to article on publisher's site
PubMed ID
22972968
Related Resources
Link to Article in PubMed
Citation Information
Carol M. Moinpour, Amy K. Darke, Gary W. Donaldson, Duane Cespedes, et al.. "Health-related quality-of-life findings for the prostate cancer prevention trial" Vol. 104 Iss. 18 (2012) ISSN: 0027-8874 (Linking)
Available at: http://works.bepress.com/john_ware/207/