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Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.
Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F.
Afiliación
  • Juraskova I; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
  • Butow P; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
  • Bonner C; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
  • Bell ML; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
  • Smith AB; Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
  • Seccombe M; Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
  • Boyle F; 1] Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia [2] Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia [3] Pam McLean Centre, The University of Sydney, Sydne
  • Reaby L; Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
  • Cuzick J; Cancer Research UK, Department of Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary College, University of London, London E1 4NS, UK.
  • Forbes JF; Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
Br J Cancer ; 111(1): 1-7, 2014 Jul 08.
Article en En | MEDLINE | ID: mdl-24892447
BACKGROUND: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. METHODS: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). RESULTS: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. CONCLUSIONS: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Participación del Paciente / Neoplasias de la Mama / Ensayos Clínicos Controlados Aleatorios como Asunto / Técnicas de Apoyo para la Decisión / Toma de Decisiones Tipo de estudio: Clinical_trials / Prognostic_studies / Qualitative_research Aspecto: Patient_preference Límite: Female / Humans / Middle aged Idioma: En Revista: Br J Cancer Año: 2014 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Participación del Paciente / Neoplasias de la Mama / Ensayos Clínicos Controlados Aleatorios como Asunto / Técnicas de Apoyo para la Decisión / Toma de Decisiones Tipo de estudio: Clinical_trials / Prognostic_studies / Qualitative_research Aspecto: Patient_preference Límite: Female / Humans / Middle aged Idioma: En Revista: Br J Cancer Año: 2014 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido