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.

COLLINS, Karen, REED, Malcolm, LIFFORD, Kate, BURTON, Maria, EDWARDS, Adrian, RING, Alistair, BRAIN, Katherine, HARDER, Helena, ROBINSON, Thompson, CHEUNG, Kwok Leung, MORGAN, Jenna, AUDISIO, Riccardo, WARD, Susan, RICHARDS, Paul, MARTIN, Charlene, CHATER, Tim, PEMBERTON, Kirsty, NETTLESHIP, Anthony, MURRAY, Christopher, WALTERS, Stephen, BORTOLAMI, Oscar, ARMITAGE, Fiona, LEONARD, Robert, GATH, Jacqui, REVELL, Deirdre, GREEN, Tracy and WYLD, Lynda (2017). 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. BMJ open, 7 (7), e015133.

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Official URL: http://bmjopen.bmj.com/content/7/7/e015133
Link to published version:: 10.1136/bmjopen-2016-015133

Abstract

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. 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. 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. 115550. 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*. [Abstract copyright: © 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.]

Item Type: Article
Additional Information: ** From PubMed via Jisc Publications Router.
Uncontrolled Keywords: Breast cancer, chemotherapy, decision aid, elderly, primary endocrine therapy, surgery
Research Institute, Centre or Group: Centre for Health and Social Care Research
Identification Number: 10.1136/bmjopen-2016-015133
SWORD Depositor: Jill Hazard
Depositing User: Jill Hazard
Date Deposited: 14 Aug 2017 10:18
Last Modified: 23 Nov 2017 21:51
URI: http://shura.shu.ac.uk/id/eprint/16510

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