Abstract | 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.
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Authors | I Juraskova, P Butow, C Bonner, M L Bell, A B Smith, M Seccombe, F Boyle, L Reaby, J Cuzick, J F Forbes |
Journal | British journal of cancer
(Br J Cancer)
Vol. 111
Issue 1
Pg. 1-7
(Jul 08 2014)
ISSN: 1532-1827 [Electronic] England |
PMID | 24892447
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Breast Neoplasms
(prevention & control)
- Decision Making
- Decision Support Techniques
- Female
- Humans
- Middle Aged
- Patient Participation
(psychology)
- Patient Satisfaction
- Randomized Controlled Trials as Topic
(methods, psychology)
- Surveys and Questionnaires
- Treatment Outcome
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