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Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

ABSTRACT: Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented.

SUBMITTER: Moore TH

PROVIDER: S-EPMC4559035 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

Moore Theresa Helen Mazzarello TH King Anna Jyoti Louise AJ Evans Maggie M Sharp Debbie D Persad Raj R Huntley Alyson Louise AL

Cancer medicine 20150401 8

Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two author ...[more]

PMID: 25828811

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Project description:Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Prostate Cancer Clinical Trials Working Groups.An international expert committee of prostate cancer clinical investigators (the Prostate Cancer Clinical Trials Working Group 3 [PCWG3]) was reconvened and expanded and met in 2012-2015 to formulate updated criteria on the basis of emerging trial data and validation studies of the Prostate Cancer Clinical Trials Working Group 2 recommendations.PCWG3 recommends that baseline patient assessment include tumor histology, detailed records of prior systemic treatments and responses, and a detailed reporting of disease subtypes based on an anatomic pattern of metastatic spread. New recommendations for trial outcome measures include the time to event end point of symptomatic skeletal events, as well as time to first metastasis and time to progression for trials in the nonmetastatic CRPC state. PCWG3 introduces the concept of no longer clinically benefiting to underscore the distinction between first evidence of progression and the clinical need to terminate or change treatment, and the importance of documenting progression in existing lesions as distinct from the development of new lesions. Serial biologic profiling using tumor samples from biopsies, blood-based diagnostics, and/or imaging is also recommended to gain insight into mechanisms of resistance and to identify predictive biomarkers of sensitivity for use in prospective trials.PCWG3 moves drug development closer to unmet needs in clinical practice by focusing on disease manifestations most likely to affect prognosis adversely for therapeutics tested in both nonmetastatic and metastatic CRPC populations. Consultation with regulatory authorities is recommended if a trial is intended to seek support for drug approval.

Project description:BackgroundAlthough relatively new, digital health interventions are demonstrating rapid growth because of their ability to facilitate access and overcome issues of location, time, health status, and most recently, the impact of a major pandemic. With the increased uptake of digital technologies, digital health has the potential to improve the provision of supportive cancer care.ObjectiveThis systematic review aims to evaluate digital health interventions for supportive cancer care.MethodsPublished literature between 2000 and 2020 was systematically searched in MEDLINE, PubMed, Embase, PsycINFO, Cochrane Central Register of Controlled Trials, and Scopus. Eligible publications were randomized controlled trials of clinician-led digital health interventions to support adult cancer patients. The interventions included were determined by applying a digital health conceptual model. Studies were appraised for quality using the revised Cochrane risk of bias tool.ResultsTwenty randomized controlled trials met the inclusion criteria for the analysis. Interventions varied by duration, frequency, degree of technology use, and applied outcome measures. Interventions targeting a single tumor stream, predominantly breast cancer, and studies involving the implementation of remote symptom monitoring have dominated the results. In most studies, digital intervention resulted in significant positive outcomes in patient-reported symptoms, levels of fatigue and pain, health-related quality of life, functional capacity, and depression levels compared with the control.ConclusionsDigital health interventions are helpful and effective for supportive care of patients with cancer. There is a need for high-quality research. Future endeavors could focus on the use of valid, standardized outcome measures, maintenance of methodological rigor, and strategies to improve patient and health professional engagement in the design and delivery of supportive digital health interventions.Trial registrationPROSPERO CRD42020149730; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=149730.

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Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

Publications

Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.

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