TY - JOUR
T1 - Health-related quality-of-life findings for the prostate cancer prevention trial
AU - Moinpour, Carol M.
AU - Darke, Amy K.
AU - Donaldson, Gary W.
AU - Cespedes, Duane
AU - Johnson, Christine R.
AU - Ganz, Patricia A.
AU - Patrick, Donald L.
AU - Ware, John E.
AU - Shumaker, Sally A.
AU - Meyskens, Frank L.
AU - Thompson, Ian M.
N1 - Funding Information:
This research was supported by Public Health Service grants no. 5 U10 CA37429 and 2 U10 CA37429-09 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD (to IMT, principal investigator).
Funding Information:
The study agents (finasteride and placebo) were provided by Merck, Inc. Merck, Inc, and the National Cancer Institute (NCI), Division of Cancer Prevention (DCP), also provided small grants to produce videos and to support projects to enhance trial recruitment and adherence. The study sponsor, DCP/NCI, provided input regarding study design but had no role in the following study activities: collection, analysis, or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication. The authors extend appreciation to PCPT participants who provided health behaviors information at study entry and faithfully completed the health-related quality-of-life and health behaviors forms over the course of the trial. Study clinical research associates and nurses were also instrumental in our ability to achieve such impressive submission rates for the participant-completed forms.
PY - 2012/9/19
Y1 - 2012/9/19
N2 - 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.
AB - 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.
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U2 - 10.1093/jnci/djs359
DO - 10.1093/jnci/djs359
M3 - Article
C2 - 22972968
AN - SCOPUS:84866677422
VL - 104
SP - 1373
EP - 1385
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
SN - 0027-8874
IS - 18
ER -