Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial.

Autor: Collins K; Centre for Health and Social Care Research, Sheffield Hallam University, Sheffield, UK., Reed M; Brighton and Sussex Medical School, University of Sussex, Brighton, UK., Lifford K; Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK., Burton M; Centre for Health and Social Care Research, Sheffield Hallam University, Sheffield, UK., Edwards A; Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK., Ring A; Royal Marsden Hospital, London, UK., Brain K; Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK., Harder H; SHORE-C, University of Sussex, Falmer, Brighton, UK., Robinson T; Department of Cardiovascular Sciences, Leicester Royal Infirmary, Infirmary Square, Leicester, UK., Cheung KL; School of Medicine, University of Nottingham, Royal Derby Hospital Centre, Nottingham, UK., Morgan J; Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK., Audisio R; Department of Surgery, University of Liverpool, Liverpool, UK., Ward S; Department of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK., Richards P; Department of Health Economics and Decision Science, School for Health and Related Research, University of Sheffield, Sheffield, UK., Martin C; Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.; University of Sheffield, Sheffield, UK., Chater T; Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK., Pemberton K; Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK., Nettleship A; Department of Epigenesys, School for Health and Related Research, University of Sheffield, Sheffield, UK., Murray C; Department of Epigenesys, School for Health and Related Research, University of Sheffield, Sheffield, UK., Walters S; Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK., Bortolami O; Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK., Armitage F; University of Sheffield, Sheffield, UK., Leonard R; Imperial College Healthcare NHS Trust, London, UK., Gath J; Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel, Sheffield, UK., Revell D; Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel, Sheffield, UK., Green T; Yorkshire and Humberside (formerly North Trent Cancer Network) Consumer Research Panel, Sheffield, UK., Wyld L; Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.; University of Sheffield, Sheffield, UK.
Jazyk: angličtina
Zdroj: BMJ open [BMJ Open] 2017 Jul 31; Vol. 7 (7), pp. e015133. Date of Electronic Publication: 2017 Jul 31.
DOI: 10.1136/bmjopen-2016-015133
Abstrakt: Introduction: While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease.
Methods and Analysis: This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing 'Age Gap Cohort Study' (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians.
Ethics and Dissemination: National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals.
Iras Reference: 115550.
Trial Registration Number: European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*.
Competing Interests: Competing interests: None declared.
(© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Databáze: MEDLINE