Time, Symptom Burden, Androgen Deprivation, and Self-Assessed Quality of Life after Radical Prostatectomy or Watchful Waiting: The Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) Clinical Trial

Department of Urology, Uppsala University Hospital, Uppsala, Sweden.
European Urology (Impact Factor: 13.94). 10/2008; 55(2):422-30. DOI: 10.1016/j.eururo.2008.08.054
Source: PubMed


Quality-of-life outcomes are important in the choice of treatment strategy for men with localized prostate cancer.
To evaluate how follow-up time, number of physical symptoms, and presence of androgen deprivation affected quality of life among men randomized to radical prostatectomy or watchful waiting.
The study group was composed of all 376 living men included in the Swedish part of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) between January 1, 1989, and February 29, 1996. Quality-of-life data were collected after a mean follow-up time of 4.1 yr.
All patients were randomly assigned to radical prostatectomy or watchful waiting. Forty-five men were androgen deprived.
Data of specific symptoms, symptom-induced stress, sense of well-being, and self-assessed quality of life were obtained by means of a questionnaire. Psychological symptoms were assessed using seven-point visual digital scales.
In analyses stratified on the basis of the numbers of physical symptoms, anxiety and depressed mood were less common, and sense of well-being and self-assessed quality of life were better throughout in the radical prostatectomy group than in the watchful waiting group. As the number of physical symptoms increased, all psychological variables became worse and more prominent in the watchful waiting group. After a follow-up time of 6-8 yr, a significant decrease in quality of life (p=0.03) was seen in the watchful waiting group. Twenty-four percent of androgen-deprived patients assigned to watchful waiting reported high self-assessed quality of life compared with 60% in the radical prostatectomy group. Eighty-eight percent of patients had clinically detected tumors.
Androgen deprivation negatively affected self-assessed quality of life in men assigned to watchful waiting. The number of physical symptoms was associated with the level of quality of life. Quality of life was lower with longer follow-up time in both groups and was statistically significant in the watchful waiting group (p=0.03).

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Available from: Eva Johansson, Mar 13, 2014
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    • "We modified the clinometric questionnaire previously used in a randomized trial evaluating the effects of radical prostatectomy, SPCG-4, to collect information on possible confounding factors, mediating factors, and effect-modifying factors [31] [32]. Most questions have been used in one or several of the 25 data collections previously carried out at the Division of Clinical Cancer Epidemiology [33] [34] [35]. Nevertheless, to make sure the questions and answer categories were understood correctly by men with a recent diagnosis of prostate cancer, the questionnaires underwent face-to-face validation. "
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    ABSTRACT: Many elderly or impotent men with prostate cancer may not receive a bundle-preserving radical prostatectomy as a result of uncertainty regarding the effect on urinary incontinence. We searched for predictors of urinary incontinence 1 yr after surgery among surgical steps during radical prostatectomy. More than 100 surgeons in 14 centers prospectively collected data on surgical steps during an open or robot-assisted laparoscopic radical prostatectomy. At 1 yr after surgery, a neutral third-party secretariat collected patient-reported information on urinary incontinence. After excluding men with preoperative urinary incontinence or postoperative irradiation, data were available for 3379 men. Surgical steps during radical prostatectomy, including dissection plane as a measure of the degree of preservation of the two neurovascular bundles. Urinary incontinence 1 yr after surgery was measured as patient-reported use of pads. In different categories of surgical steps, we calculated the percentage of men changing pads "about once per 24 h" or more often. Relative risks were calculated as percentage ratios between categories. A strong association was found between the degree of bundle preservation and urinary incontinence 1 yr after surgery. We set the highest degree of bundle preservation (bilateral intrafascial dissection) as the reference category (relative risk = 1.0). For the men in the remaining six groups, ordered according to the degree of preservation, we obtained the following relative risks (95% confidence interval [CI]): 1.07 (0.63-1.83), 1.19 (0.77-1.85), 1.56 (0.99-2.45), 1.78 (1.13-2.81), 2.27 (1.45-3.53), and 2.37 (1.52-3.69). In the latter group, no preservation of any of the bundles was performed. The pattern was similar for preoperatively impotent men and for elderly men. Limitations of this analysis include the fact that noise influences the relative risks, due to variations between surgeons in the use of undocumented surgical steps of the procedure, variations in surgical experience and in how the surgical steps are reported, as well as variations in the metrics of patient-reported use of pads. We found that the degree of preservation of the two neurovascular bundles during radical prostatectomy predicts the rate of urinary incontinence 1 yr after the operation. According to our findings, preservation of both neurovascular bundles to avoid urinary incontinence is also meaningful for elderly and impotent men. We studied the degree of preservation of the two neurovascular bundles during radical prostatectomy and found that the risk of incontinence decreases if the surgeon preserves two bundles instead of one, and if the surgeon preserves some part of a bundle rather than not doing so. Copyright © 2014. Published by Elsevier B.V.
    Full-text · Article · Oct 2014 · European Urology
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    • "Patients' anxiety and depression levels were relatively unaffected at the time of diagnosis, as mean scores were within the normal range of the HADS questionnaire. These scores might have been expected to deteriorate over time, as other studies have shown a high incidence of anxiety, depression, and distress [7, 15]. However, depression remained largely unchanged while anxiety actually lessened after treatment. "
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    ABSTRACT: Objective. To assess the impact of low-to-moderate risk prostate cancer on patients' quality of life (QoL) at diagnosis and within the first year of treatment. Subjects and Methods. Men (n = 672) aged 50-75 years with prostate cancer (Gleason score ≤7, PSA ≤20 ng/mL and clinical staging T1c-T2b) were enrolled in five European countries. Patients completed five questionnaires, including EORTC Quality of Life Questionnaire-Prostate Cancer 25 (QLQ-PR25) and EORTC Quality of Life Questionnaire-Cancer 30 (QLQ-C30). Questionnaires were completed at baseline, at 3 months and 12 months after starting treatment. The primary endpoint was the change in QLQ-PR25 urinary symptoms subscale score from baseline to the assessment at 3 months. Results. Mean (SD) age was 65.0 (5.7) years and 400 (66%) men had Gleason score ≤6 prostate cancer. The most frequently used initial treatment was radical prostatectomy (71% of patients). QLQ-PR25 urinary symptoms subscale score was significantly increased at 3 months (P < 0.001), indicating that urinary symptoms worsened after treatment. The score was lower at 12 months than at 3 months, but it was still significantly higher than at baseline (P < 0.001). Hormonal treatment-related symptoms, sexual functioning, and sexual activity scores significantly worsened at 3 and 12 months (all P < 0.001). For the QLQ-C30 questionnaire, global health status/QoL score significantly decreased at month 3 but was not different from baseline by month 12. Scales for physical, role, and social functioning, and fatigue, showed significant deterioration at 3 and 12 months. Conclusions. Low-to-moderate risk prostate cancer may have a substantial effect on patients' QoL within one year following treatment.
    Full-text · Article · Mar 2014
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    • "Before the study start, the study variables were defined, developed and validated by a mixed-methods approach. The study-specific questionnaires were based on in-depth interviews with prostate cancer patients, on measures used in research on post-traumatic stress disorder [1] as well as on previous questionnaires developed within our research group [12,19,20]. Firstly, transcriptions of the in-depth interviews were analyzed hierarchically and emerging themes were turned into questions. "
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    ABSTRACT: Sudden, unwelcome and repetitive thoughts about a traumatic event -- intrusive thoughts -- could relate to how men assess their quality of life after prostate-cancer diagnosis. We aimed to study the prevalence of intrusive thoughts about prostate cancer and their association with quality-of-life outcomes before and after radical prostatectomy. During the first year of the LAPPRO-trial, 971 men scheduled for radical prostatectomy were prospectively included from 14 urological centers in Sweden. Of those, 833 men responded to two consecutive study-specific questionnaires before and three months after surgery (participation rate 86%). The association of intrusive thoughts with three quality-of-life outcomes, i.e. self-assessed quality of life, depressive mood and waking up with anxiety was estimated by prevalence ratios that were calculated, together with a 95% confidence interval, at the same time-point as well as over time. Fisher's exact-test was used to analyze differences between respondents and non-respondents. Wilcoxon signed-ranks and Cochran-Armitage trend tests were used for analysis of change over time. To validate new questions on intrusive thoughts, written answers to open-ended questions were read and analyzed by qualitative content analysis. Before surgery, 603 men (73%) reported negative intrusive thoughts about their cancer at some time in the past month and 593 men (59%) reported such thoughts three months after surgery. Comparing those reporting intrusive thoughts at least weakly before surgery with those who did not, the prevalence ratio (95% confidence interval), three months after surgery, for waking up in the middle of the night with anxiety was 3.9 (2.7 to 5.5), for depressed mood 1.8 (1.6 to 2.1) and for impaired self-assessed quality of life 1.3 (1.2 to 1.5). The prevalence of negative intrusive thoughts about prostate cancer at the time of surgery associates with studied quality-of-life outcomes three months later.Trial registrationCurrent Controlled Trials ISRCTN06393679.
    Full-text · Article · Sep 2013 · Health and Quality of Life Outcomes
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