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Collins, Karen and Reed, Malcolm and Lifford, Kate and Burton, Maria and Edwards, Adrian and Ring, Alistair and Brain, Katherine and Harder, Helena and Robinson, Thompson and Cheung, Kwok-Leung and Morgan, Jenna and Audisio, Riccardo and Ward, Susan and Richards, Paul and Martin, Charlene and Chater, Tim and Pemberton, Kirsty and Nettleship, Anthony and Murray, Christopher and Walters, Stephen and Bortolami, Oscar and Armitage, Fiona and Leonard, Robert and Gath, Jacqui and Revell, Deirdre and 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). e015133/1-e015133/8. ISSN 2044-6055

Abstract

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.

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