Health-related quality-of-life findings for the prostate cancer prevention trial

Carol M. Moinpour, Amy K. Darke, Gary W. Donaldson, Duane Cespedes, Christine R. Johnson, Patricia A. Ganz, Donald L. Patrick, John E. Ware, Sally A. Shumaker, Frank L. Meyskens, Ian M. Thompson

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background The Prostate Cancer Prevention Trial (PCPT)a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate canceroffered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. MethodsWe assessed three health-related quality-of-life domains (measured with the Health Survey Short Form36: 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. ResultsFor 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. ConclusionFinasteride did not negatively affect SF36 Physical Functioning, Mental Health, or Vitality scores.

Original languageEnglish (US)
Pages (from-to)1373-1385
Number of pages13
JournalJournal of the National Cancer Institute
Volume104
Issue number18
DOIs
StatePublished - Sep 19 2012

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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