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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:PurposeTo identify supportive care interventions for men with urological cancers.MethodsExperimental studies conducted among men with any urological cancer were eligible for inclusion. Academic Search Complete, CINAHL Plus with Full Text, MEDLINE, APA PsycArticles, APA PsycInfo, Social Sciences Full Text (H.W. Wilson), SocINDEX with Full Text, ERIC, Google Scholar and ClinicalTrials.gov were searched on 6 December 2022. No database limits were applied. The included studies were methodologically appraised. A narrative synthesis of the results was conducted.ResultsThirty studies were included with 10 categories of interventions identified. Over 300 outcomes were measured, and more than 100 instruments were used. Multicomponent interventions generally led to positive changes in physiological outcomes like body mass index, as well as exercise tolerance and quality of life. This change, however, was not sustained in the long term. Cognitive-behavioural interventions significantly improved psychological symptoms but seldom physical symptoms. Telephone and web-based interventions showed great promise in improving outcomes like depression, positive affect, negative affect, perceived stress, spiritual wellbeing and fatigue. Findings from physical activity/exercise-based interventions were promising for both, physical and psychological outcomes. Rehabilitative interventions were associated with significant improvements in quality of life, urinary symptoms and psychological symptoms, albeit in the short term. Mixed results were reported for nurse-led interventions, family-based interventions and nutritional interventions.ConclusionAll but one study focused exclusively on prostate cancer. The included studies were significantly heterogeneous. Multicomponent, cognitive-behavioural, telephone and web-based, physical activity/exercise-based and rehabilitative interventions showed great promise in improving various outcomes. This improvement, however, was often short-lived.

Project description:PurposeEvolving 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.MethodsAn 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.ResultsPCWG3 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.ConclusionPCWG3 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:Simple Summary Early-onset cancers, defined as cancers in adults aged 18 to 49 years, are increasing in a number of cancer sites in developed countries. Cancers commonly seen in older people are now being diagnosed in younger adults, for example bowel, breast, stomach and pancreatic cancers. In this review, we report statistics about early-onset cancers using exemplar data from a UK region and discuss issues unique to this age group. Topics covered include the long-term consequences of cancer treatment, how cancer treatment affects fertility and the use of social media by patients, healthcare professionals and researchers. We also outline important future research priorities for early-onset cancers. Abstract Rising incidence of specific types of early-age onset cancers in adults aged 18–49 years has been reported in high-income countries. In this review, we summarise the epidemiology of early-onset cancers using exemplar data from a high-income UK region, discuss supportive care needs for young patients and outline future research directions. The incidence rate of early-onset cancers increased by 20.5% from 1993 to 2019 in Northern Ireland. Differences in types of cancer were observed between sexes and across age groups of 18–29, 30–39 and 40–49 years. One and five-year net survival was mostly better in 18–29-year-olds for all cancers combined compared to older age groups for both sexes, but there were variations in specific cancer types. Poorer survival was observed for patients with brain/central nervous system, connective and soft tissue or lung cancers. Patients with early-onset cancers face unique supportive care needs and require holistic care. The impact of cancer treatment on fertility and fertility preservation treatments is an important consideration. Social media can be used for patient support, information, fundraising, advocacy work and recruitment to research studies. We also outline suggested future research priorities for early-onset cancers, spanning prevention, diagnosis, treatment and supportive care needs.

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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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