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      The ProCaSP study: quality of life outcomes of prostate cancer patients after radiotherapy or radical prostatectomy in a cohort study

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          Abstract

          Background

          This study describes and compares health-related quality of life (HRQOL) of prostate cancer patients who received either radical prostatectomy (nerve-sparing, nsRP, or non-nerve-sparing, nnsRP) or radiotherapy (external RT, brachytherapy, or both combined) for treatment of localised prostate cancer.

          Methods

          The prospective, multicenter cohort study included 529 patients. Questionnaires included the IIEF, QLQ-C30, and PORPUS-P. Data were collected before (baseline), three, six, twelve, and twenty-four months after treatment. Differences between groups’ baseline characteristics were assessed; changes over time were analysed with generalised estimating equations (GEE). Missing values were treated with multiple imputation. Further, scores at baseline and end of follow-up were compared to German reference data.

          Results

          The typical time trend was a decrease of average HRQOL three months after treatment followed by (partial) recovery. RP patients experienced considerable impairment in sexual functioning. The covariate-adjusted GEE identified a significant - but not clinically relevant - treatment effect for diarrhoea (b = 7.0 for RT, p = 0.006) and PORPUS-P (b = 2.3 for nsRP, b = 2.2 for RT, p = 0.045) compared to the reference nnsRP. Most of the HRQOL scores were comparable to German norm values.

          Conclusions

          Findings from previous research were reproduced in a specific setting of a patient cohort in the German health care system. According to the principle of evidence-based medicine, this strengthens the messages regarding treatment in prostate cancer and its impacts on patients’ health-related quality of life. After adjustment for baseline HRQOL and other covariates, RT patients reported increased symptoms of diarrhoea, and nnsRP patients decreased prostate-specific HRQOL. RP patients experienced considerable impairment in sexual functioning. These differences should be taken into account by physicians when choosing the best therapy for a patient.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12894-015-0025-6) contains supplementary material, which is available to authorized users.

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          Most cited references33

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          R: A Language and Environment for Statistical Computing.

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            Mortality results from a randomized prostate-cancer screening trial.

            The effect of screening with prostate-specific-antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality. From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of all cancers and deaths and causes of death were ascertained. In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval [CI], 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consistent with these overall findings. After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540.) 2009 Massachusetts Medical Society
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              Interpreting the significance of changes in health-related quality-of-life scores.

              To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.
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                Author and article information

                Contributors
                nora.eisemann@uksh.de
                Sandra.Nolte@charite.de
                maike.schnoor@uksh.de
                alexander.katalinic@uksh.de
                vrohde@gmx.de
                annika.waldmann@uksh.de
                Journal
                BMC Urol
                BMC Urol
                BMC Urology
                BioMed Central (London )
                1471-2490
                10 April 2015
                10 April 2015
                2015
                : 15
                : 28
                Affiliations
                [ ]Institute of Cancer Epidemiology, University of Luebeck, Ratzeburger Allee 160, 23562 Luebeck, Germany
                [ ]Medical Clinic, Department of Psychosomatic Medicine, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany
                [ ]Deakin University, 221 Burwood Highway, Burwood, VIC 3125 Australia
                [ ]Institute of Social Medicine and Epidemiology, University Hospital Schleswig-Holstein, Campus Luebeck, Ratzeburger Allee 160, 23562 Luebeck, Germany
                [ ]Medical Practice of Urology, Auguststr. 4, 23611 Bad Schwartau, Germany
                [ ]Department of Urology, Pediatric Urology and Andrology, Justus Liebig University of Giessen, Rudolf-Buchheim-Str. 7, 35392 Giessen, Germany
                Article
                25
                10.1186/s12894-015-0025-6
                4404598
                25885890
                b0e6a509-8d17-49f3-a717-7755503ced1b
                © Eisemann et al.; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 27 October 2014
                : 25 March 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Urology
                prostatic neoplasms,radiotherapy,prostatectomy,quality of life,cohort study
                Urology
                prostatic neoplasms, radiotherapy, prostatectomy, quality of life, cohort study

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