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Randomized Controlled Trial
. 2014 Jul 8;111(1):1-7.
doi: 10.1038/bjc.2014.144. Epub 2014 Jun 3.

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

I Juraskova  1 , P Butow  1 , C Bonner  1 , M L Bell  1 , A B Smith  1 , M Seccombe  2 , F Boyle  3 , L Reaby  2 , J Cuzick  4 , J F Forbes  2
Affiliations
Randomized Controlled Trial

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

I Juraskova et al. Br J Cancer. .

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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Figures

Figure 1
Figure 1
Recruitment flowchart: total (Prevention/DCIS).
See this image and copyright information in PMC

References

    1. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003;23:281–292. - PubMed
    1. Brehaut JC, Saginur R, Elwyn G. Informed consent documentation necessary but not sufficient. Contemp Clin Trials. 2009;30:388–389. - PubMed
    1. Brehaut JC, Fergusson DA, Kimmelman J, Shojania K, Saginur R, Elwyn G. Using decision aids may improve informed consent for research. Contemp Clin Trials. 2010;31:218–220. - PubMed
    1. Brown RF, Butow PN, Ellis P, Boyle F, Tattersall MHN. Seeking informed consent to cancer clinical trials: describing current practice. Soc Sci Med. 2004;58:2445–2457. - PubMed
    1. Cohen J. A Power Primer. Psychol Bull. 1992;112:155–159. - PubMed

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