BACKGROUND: Studies enumerating the dynamics of physical and emotional symptoms following prostate cancer (PCa) treatment are needed to guide therapeutic strategy. Yet, overcoming patient selection forces is a formidable challenge for observational studies comparing treatment groups. OBJECTIVE: To compare patterns of symptom burden and distress in men with localized PCa randomized toradical prostatectomy (RP) or watchful waiting (WW) and followed up longitudinally. DESIGN, SETTING, AND PARTICIPANTS: The three largest, Swedish, randomization centers for the Scandinavian Prostate Cancer Group-4 trial conducted a longitudinal study to assess symptoms and distress from several psychological and physical domains by mailed questionnaire every 6 mo for 2 yr and then yearly through 8 yr of follow-up. INTERVENTION: RP compared with WW. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A questionnaire was mailed at baseline and then repeatedly during follow-up with questions concerning physical and mental symptoms. Each analysis of quality of life was based on a dichotomization of the outcome (yes vs no) studied in a binomial response, generalized linear mixed model. RESULTS AND LIMITATIONS: Of 347 randomized men, 272 completed at least five questionnaires during an 8-yr follow-up period. Almost all men reported that PCa negatively influenced daily activities and relationships. Health-related distress, worry, feeling low, and insomnia were consistently reported by approximately 30-40% in both groups. Men in the RP group consistently reported more leakage, impaired erection and libido, and fewer obstructive voiding symptoms. For men in the WW group, distress related to erectile symptoms increased gradually over time. Symptom burden and distress at baseline was predictive of long-term outlook. CONCLUSIONS: Cancer negatively influenced daily activities among almost all men in both treatment groups; health-related distress was common. Trade-offs exist between physiologic symptoms, highlighting the importance of tailored treatment decision-making. Men who are likely to experience profound long-term distress can be identified early in disease management.
RCT Entities:
BACKGROUND: Studies enumerating the dynamics of physical and emotional symptoms following prostate cancer (PCa) treatment are needed to guide therapeutic strategy. Yet, overcoming patient selection forces is a formidable challenge for observational studies comparing treatment groups. OBJECTIVE: To compare patterns of symptom burden and distress in men with localized PCa randomized to radical prostatectomy (RP) or watchful waiting (WW) and followed up longitudinally. DESIGN, SETTING, AND PARTICIPANTS: The three largest, Swedish, randomization centers for the Scandinavian Prostate Cancer Group-4 trial conducted a longitudinal study to assess symptoms and distress from several psychological and physical domains by mailed questionnaire every 6 mo for 2 yr and then yearly through 8 yr of follow-up. INTERVENTION: RP compared with WW. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A questionnaire was mailed at baseline and then repeatedly during follow-up with questions concerning physical and mental symptoms. Each analysis of quality of life was based on a dichotomization of the outcome (yes vs no) studied in a binomial response, generalized linear mixed model. RESULTS AND LIMITATIONS: Of 347 randomized men, 272 completed at least five questionnaires during an 8-yr follow-up period. Almost all men reported that PCa negatively influenced daily activities and relationships. Health-related distress, worry, feeling low, and insomnia were consistently reported by approximately 30-40% in both groups. Men in the RP group consistently reported more leakage, impaired erection and libido, and fewer obstructive voiding symptoms. For men in the WW group, distress related to erectile symptoms increased gradually over time. Symptom burden and distress at baseline was predictive of long-term outlook. CONCLUSIONS: Cancer negatively influenced daily activities among almost all men in both treatment groups; health-related distress was common. Trade-offs exist between physiologic symptoms, highlighting the importance of tailored treatment decision-making. Men who are likely to experience profound long-term distress can be identified early in disease management.
Authors: Robin Wm Vernooij; Michelle Lancee; Anne Cleves; Philipp Dahm; Chris H Bangma; Katja Kh Aben Journal: Cochrane Database Syst Rev Date: 2020-06-04
Authors: J L Donovan; F C Hamdy; J A Lane; D E Neal; M Mason; C Metcalfe; E Walsh; J M Blazeby; T J Peters; P Holding; S Bonnington; T Lennon; L Bradshaw; D Cooper; P Herbert; J Howson; A Jones; N Lyons; E Salter; P Thompson; S Tidball; J Blaikie; C Gray; P Bollina; J Catto; A Doble; A Doherty; D Gillatt; R Kockelbergh; H Kynaston; A Paul; P Powell; S Prescott; D J Rosario; E Rowe; M Davis; E L Turner; R M Martin Journal: N Engl J Med Date: 2016-09-14 Impact factor: 91.245
Authors: Anna Bill-Axelson; Lars Holmberg; Hans Garmo; Jennifer R Rider; Kimmo Taari; Christer Busch; Stig Nordling; Michael Häggman; Swen-Olof Andersson; Anders Spångberg; Ove Andrén; Juni Palmgren; Gunnar Steineck; Hans-Olov Adami; Jan-Erik Johansson Journal: N Engl J Med Date: 2014-03-06 Impact factor: 91.245