Health-Related Quality-of-Life Findings for the Prostate Cancer Prevention Trial
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2012/09/12
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Details
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Personal Author:Cespedes D ; Darke AK ; Donaldson GW ; Ganz PA ; Johnson CR ; Meyskens FL ; Moinpour CM ; Patrick DL ; Shumaker SA ; Thompson IM Jr ; Ware JE Jr.
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Description: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. [Description provided by NIOSH]
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ISSN:0027-8874
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Place as Subject:California ; Maryland ; Massachusetts ; North Carolina ; OSHA Region 1 ; OSHA Region 10 ; OSHA Region 3 ; OSHA Region 4 ; OSHA Region 6 ; OSHA Region 8 ; OSHA Region 9 ; Texas ; Utah ; Washington
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Volume:104
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Issue:18
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NIOSHTIC Number:nn:20056976
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Citation:J Natl Cancer Inst 2012 Sep; 104(18):1373-1385
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Contact Point Address:Carol M. Moinpour, PhD, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, M3-C102, 1100 Fairview Ave North, PO Box 19024, Seattle, WA 98109-1024
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Email:cmoinpou@fhcrc.org
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Federal Fiscal Year:2012
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Performing Organization:University of Washington
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Peer Reviewed:True
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Start Date:20050701
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Source Full Name:Journal of the National Cancer Institute
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End Date:20250630
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Main Document Checksum:urn:sha-512:1dfe2421adc4f0981677471ed3a602e7736477eda22b980805c9d4addca99fc825eacf6746e0c8d38d330d3de5fa55b529f780306ecb99b58bdcb98b9e111675
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