PMID- 33760077 OWN - NLM STAT- MEDLINE DCOM- 20211004 LR - 20230801 IS - 1365-2168 (Electronic) IS - 0007-1323 (Print) IS - 0007-1323 (Linking) VI - 108 IP - 5 DP - 2021 May 27 TI - Bridging the age gap in breast cancer: cluster randomized trial of two decision support interventions for older women with operable breast cancer on quality of life, survival, decision quality, and treatment choices. PG - 499-510 LID - 10.1093/bjs/znab005 [doi] AB - 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). CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. FAU - Wyld, L AU - Wyld L AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. FAU - Reed, M W R AU - Reed MWR AUID- ORCID: 0000-0001-7442-2132 AD - Brighton and Sussex Medical School, Falmer, Brighton, UK. FAU - Collins, K AU - Collins K AD - College of Health, Wellbeing and Life Sciences, Department of Allied Health Professions, Sheffield Hallam University, Sheffield, UK. FAU - Burton, M AU - Burton M AD - College of Health, Wellbeing and Life Sciences, Department of Allied Health Professions, Sheffield Hallam University, Sheffield, UK. FAU - Lifford, K AU - Lifford K AD - Division of Population Medicine, Cardiff University, Cardiff, UK. FAU - Edwards, A AU - Edwards A AD - Division of Population Medicine, Cardiff University, Cardiff, UK. FAU - Ward, S AU - Ward S AUID- ORCID: 0000-0002-3344-0913 AD - Department of Health Economics and Decision Science, School for Health and Related Research, ScHARR, University of Sheffield, Sheffield, UK. FAU - Holmes, G AU - Holmes G AUID- ORCID: 0000-0002-8861-9638 AD - Department of Health Economics and Decision Science, School for Health and Related Research, ScHARR, University of Sheffield, Sheffield, UK. FAU - Morgan, J AU - Morgan J AUID- ORCID: 0000-0002-5337-5581 AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. FAU - Bradburn, M AU - Bradburn M AD - Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Walters, S J AU - Walters SJ AD - Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Ring, A AU - Ring A AD - Royal Marsden Hospital NHS Foundation Trust, London, UK. FAU - Robinson, T G AU - Robinson TG AD - Department of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, Cardiovascular Research Centre, Glenfield General Hospital, Leicester, UK. FAU - Martin, C AU - Martin C AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. FAU - Chater, T AU - Chater T AD - Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Pemberton, K AU - Pemberton K AD - Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Shrestha, A AU - Shrestha A AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. FAU - Nettleship, A AU - Nettleship A AD - EpiGenesys, University of Sheffield, Sheffield, UK. FAU - Murray, C AU - Murray C AUID- ORCID: 0000-0001-6939-4384 AD - EpiGenesys, University of Sheffield, Sheffield, UK. FAU - Brown, M AU - Brown M AD - EpiGenesys, University of Sheffield, Sheffield, UK. FAU - Richards, P AU - Richards P AD - Department of Health Economics and Decision Science, School for Health and Related Research, ScHARR, University of Sheffield, Sheffield, UK. FAU - Cheung, K L AU - Cheung KL AD - University of Nottingham, Royal Derby Hospital, Derby, UK. FAU - Todd, A AU - Todd A AD - Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. FAU - Harder, H AU - Harder H AD - Brighton and Sussex Medical School, Falmer, Brighton, UK. FAU - Brain, K AU - Brain K AD - Division of Population Medicine, Cardiff University, Cardiff, UK. FAU - Audisio, R A AU - Audisio RA AUID- ORCID: 0000-0002-7538-4809 AD - University of Gothenberg, Sahlgrenska Universitetssjukhuset, Gothenberg, Sweden. FAU - Wright, J AU - Wright J AD - Brighton and Sussex Medical School, Falmer, Brighton, UK. FAU - Simcock, R AU - Simcock R AD - Brighton and Sussex Medical School, Falmer, Brighton, UK. FAU - Armitage, F AU - Armitage F AD - Weston Park Hospital, Sheffield, UK. FAU - Bursnall, M AU - Bursnall M AD - Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. FAU - Green, T AU - Green T AD - Yorkshire and Humber Consumer Research Panel (yhcrp.org.uk), Leeds, UK. FAU - Revell, D AU - Revell D AD - Yorkshire and Humber Consumer Research Panel (yhcrp.org.uk), Leeds, UK. FAU - Gath, J AU - Gath J AD - Yorkshire and Humber Consumer Research Panel (yhcrp.org.uk), Leeds, UK. FAU - Horgan, K AU - Horgan K AD - Department of Breast Surgery, Bexley Cancer Centre, St James's University Hospital, Leeds, UK. FAU - Holcombe, C AU - Holcombe C AD - Liverpool University Hospitals Foundation Trust, Liverpool, UK. FAU - Winter, M AU - Winter M AD - Weston Park Hospital, Sheffield, UK. FAU - Naik, J AU - Naik J AD - Pinderfields Hospital, Mid Yorkshire NHS Foundation Trust, Wakefield, UK. FAU - Parmeshwar, R AU - Parmeshwar R AD - University Hospitals of Morecambe Bay, Lancaster, UK. FAU - Gosney, M AU - Gosney M AD - Royal Berkshire NHS Foundation Trust, Reading, UK. FAU - Hatton, M AU - Hatton M AD - Weston Park Hospital, Sheffield, UK. FAU - Thompson, A M AU - Thompson AM AD - Department of Surgery, Baylor College of Medicine, Houston, Texas, USA. LA - eng PT - Journal Article PT - Multicenter Study PT - Pragmatic Clinical Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Br J Surg JT - The British journal of surgery JID - 0372553 RN - 0 (Antineoplastic Agents, Hormonal) SB - IM MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents, Hormonal/therapeutic use MH - Breast Neoplasms/mortality/*therapy MH - Chemotherapy, Adjuvant MH - *Decision Making MH - *Decision Support Techniques MH - Female MH - Health Knowledge, Attitudes, Practice MH - Humans MH - Quality of Life PMC - PMC10364907 EDAT- 2021/03/25 06:00 MHDA- 2021/10/05 06:00 PMCR- 2021/03/23 CRDT- 2021/03/24 12:55 PHST- 2020/06/08 00:00 [received] PHST- 2020/10/04 00:00 [revised] PHST- 2020/12/28 00:00 [accepted] PHST- 2021/03/25 06:00 [pubmed] PHST- 2021/10/05 06:00 [medline] PHST- 2021/03/24 12:55 [entrez] PHST- 2021/03/23 00:00 [pmc-release] AID - 6182547 [pii] AID - znab005 [pii] AID - 10.1093/bjs/znab005 [doi] PST - ppublish SO - Br J Surg. 2021 May 27;108(5):499-510. doi: 10.1093/bjs/znab005.