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Bridging the age gap in breast cancer: cluster randomized trial of the effects of two decision support interventions for older women with operable breast cancer on quality of life, survival, decision quality, and treatment choices.

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posted on 07.05.2021, 15:33 by L Wyld, MWR Reed, K Collins, M Burton, K Lifford, A Edwards, S Ward, G Holmes, J Morgan, M Bradburn, SJ Walters, A Ring, TG Robinson, C Martin, T Chater, K Pemberton, A Shrestha, A Nettleship, C Murray, M Brown, P Richards, KL Cheung, A Todd, H Harder, K Brain, RA Audisio, J Wright, R Simcock, F Armitage, M Bursnall, T Green, D Revell, J Gath, K Horgan, C Holcombe, M Winter, J Naik, R Parmeshwar, M Gosney, M Hatton, AM Thompson

Background

Rates of surgery and adjuvant therapy for breast cancer vary widely between breast units. This may contribute to differences in survival. This cluster RCT evaluated the impact of decision support interventions (DESIs) for older women with breast cancer, to ascertain whether DESIs influenced quality of life, survival, decision quality, and treatment choice.

Methods

A multicentre cluster RCT compared the use of two DESIs against usual care in treatment decision-making in older women (aged at least ≥70 years) with breast cancer. Each DESI comprised an online algorithm, booklet, and brief decision aid to inform choices between surgery plus adjuvant endocrine therapy versus primary endocrine therapy, and adjuvant chemotherapy versus no chemotherapy. The primary outcome was quality of life. Secondary outcomes included decision quality measures, survival, and treatment choice.

Results

A total of 46 breast units were randomized (21 intervention, 25 usual care), recruiting 1339 women (670 intervention, 669 usual care). There was no significant difference in global quality of life at 6 months after the baseline assessment on intention-to-treat analysis (difference -0.20, 95 per cent confidence interval (C.I.) -2.69 to 2.29; P = 0.900). In women offered a choice of primary endocrine therapy versus surgery plus endocrine therapy, knowledge about treatments was greater in the intervention arm (94 versus 74 per cent; P = 0.003). Treatment choice was altered, with a primary endocrine therapy rate among women with oestrogen receptor-positive disease of 21.0 per cent in the intervention versus 15.4 per cent in usual-care sites (difference 5.5 (95 per cent C.I. 1.1 to 10.0) per cent; P = 0.029). The chemotherapy rate was 10.3 per cent at intervention versus 14.8 per cent at usual-care sites (difference -4.5 (C.I. -8.0 to 0) per cent; P = 0.013). Survival was similar in both arms.

Conclusion

The use of DESIs in older women increases knowledge of breast cancer treatment options, facilitates shared decision-making, and alters treatment selection.Trial registration numbers: EudraCT 2015-004220-61 (https://eudract.ema.europa.eu/), ISRCTN46099296 (http://www.controlled-trials.com).

History

Citation

British Journal of Surgery, znab005, https://doi.org/10.1093/bjs/znab005

Author affiliation

Department of Cardiovascular Sciences

Version

VoR (Version of Record)

Published in

British Journal of Surgery

Publisher

Oxford University Press (OUP) for British Journal of Surgery Society

issn

0007-117X

eissn

1365-2168

Acceptance date

28/12/2020

Copyright date

2021

Available date

07/05/2021

Spatial coverage

England

Language

eng