L Wyld1, M W R Reed2, K Collins3, M Burton3, K Lifford4, A Edwards4, S Ward5, G Holmes5, J Morgan1, M Bradburn6, S J Walters6, A Ring7, T G Robinson8, C Martin1, T Chater6, K Pemberton6, A Shrestha1, A Nettleship9, C Murray9, M Brown9, P Richards5, K L Cheung10, A Todd1, H Harder2, K Brain4, R A Audisio11, J Wright2, R Simcock2, F Armitage12, M Bursnall6, T Green13, D Revell13, J Gath13, K Horgan14, C Holcombe15, M Winter12, J Naik16, R Parmeshwar17, M Gosney18, M Hatton12, A M Thompson19. 1. Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK. 2. Brighton and Sussex Medical School, Falmer, Brighton, UK. 3. College of Health, Wellbeing and Life Sciences, Department of Allied Health Professions, Sheffield Hallam University, Sheffield, UK. 4. Division of Population Medicine, Cardiff University, Cardiff, UK. 5. Department of Health Economics and Decision Science, School for Health and Related Research, ScHARR, University of Sheffield, Sheffield, UK. 6. Clinical Trials Research Unit, School for Health and Related Research, University of Sheffield, Sheffield, UK. 7. Royal Marsden Hospital NHS Foundation Trust, London, UK. 8. Department of Cardiovascular Sciences and NIHR Biomedical Research Centre, University of Leicester, Cardiovascular Research Centre, Glenfield General Hospital, Leicester, UK. 9. EpiGenesys, University of Sheffield, Sheffield, UK. 10. University of Nottingham, Royal Derby Hospital, Derby, UK. 11. University of Gothenberg, Sahlgrenska Universitetssjukhuset, Gothenberg, Sweden. 12. Weston Park Hospital, Sheffield, UK. 13. Yorkshire and Humber Consumer Research Panel (yhcrp.org.uk), Leeds, UK. 14. Department of Breast Surgery, Bexley Cancer Centre, St James's University Hospital, Leeds, UK. 15. Liverpool University Hospitals Foundation Trust, Liverpool, UK. 16. Pinderfields Hospital, Mid Yorkshire NHS Foundation Trust, Wakefield, UK. 17. University Hospitals of Morecambe Bay, Lancaster, UK. 18. Royal Berkshire NHS Foundation Trust, Reading, UK. 19. Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Abstract
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).
RCT Entities:
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).
Authors: Felipe Andrés Cordero da Luz; Eduarda da Costa Marinho; Camila Piqui Nascimento; Lara de Andrade Marques; Patrícia Ferreira Ribeiro Delfino; Rafael Mathias Antonioli; Rogério Agenor de Araújo; Marcelo José Barbosa Silva Journal: Ecancermedicalscience Date: 2022-03-03
Authors: Felipe Andrés Cordero da Luz; Eduarda da Costa Marinho; Camila Piqui Nascimento; Lara de Andrade Marques; Patrícia Ferreira Ribeiro Delfino; Rafael Mathias Antonioli; Marcelo José Barbosa Silva; Rogério Agenor de Araújo Journal: Ecancermedicalscience Date: 2022-01-20
Authors: Willeke G van der Plas-Krijgsman; Jenna L Morgan; Nienke A de Glas; Anna Z de Boer; Charlene L Martin; Geoffrey R Holmes; Susan E Ward; Tim Chater; Malcolm W Reed; Jos W S Merkus; Thijs van Dalen; Annelie J E Vulink; Leander van Gerven; Onno R Guicherit; Eugenie Linthorst-Niers; Titia E Lans; Esther Bastiaannet; Johanneke E A Portielje; Gerrit Jan Liefers; Lynda Wyld Journal: Eur J Cancer Date: 2022-01-23 Impact factor: 9.162
Authors: Felipe Andrés Cordero da Luz; Eduarda da Costa Marinho; Camila Piqui Nascimento; Lara de Andrade Marques; Patrícia Ferreira Ribeiro Delfino; Rafael Mathias Antonioli; Rogério Agenor de Araújo; Marcelo José Barbosa Silva Journal: Ecancermedicalscience Date: 2022-05-04
Authors: Maria Burton; Kate J Lifford; Lynda Wyld; Fiona Armitage; Alistair Ring; Anthony Nettleship; Karen Collins; Jenna Morgan; Malcolm W R Reed; Geoffrey R Holmes; Mike Bradburn; Jacqui Gath; Tracy Green; Deirdre Revell; Kate Brain; Adrian Edwards Journal: Trials Date: 2021-07-13 Impact factor: 2.279
Authors: Neil Carleton; Azadeh Nasrazadani; Kristine Gade; Sushil Beriwal; Parul N Barry; Adam M Brufsky; Rohit Bhargava; Wendie A Berg; Margarita L Zuley; G J van Londen; Oscar C Marroquin; Darcy L Thull; Phuong L Mai; Emilia J Diego; Michael T Lotze; Steffi Oesterreich; Priscilla F McAuliffe; Adrian V Lee Journal: Lancet Healthy Longev Date: 2022-01-05