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; P. Butow; C. Bonner; M. L. Bell; A. B. Smith; M. Seccombe; F. Boyle; L. Reaby; J. Cuzick; J. F. Forbes

doi:10.1038/bjc.2014.144

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
, P. Butow
, C. Bonner
, M. L. Bell
, A. B. Smith
, M. Seccombe
, F. Boyle
, L. Reaby
, J. Cuzick
, J. F. Forbes

Research output: Contribution to journal › Article › peer-review

48 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1-7
Number of pages	7
Journal	British journal of cancer
Volume	111
Issue number	1
DOIs	https://doi.org/10.1038/bjc.2014.144
State	Published - Jul 2014
Externally published	Yes

Keywords

International Breast Cancer Intervention Study-II (IBIS-II)
clinical trial recruitment
decision aids
decisional conflict
informed consent
randomised controlled trial

ASJC Scopus subject areas

Oncology
Cancer Research

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10.1038/bjc.2014.144

Cite this

Juraskova, I., Butow, P., Bonner, C., Bell, M. L., Smith, A. B., Seccombe, M., Boyle, F., Reaby, L., Cuzick, J., & Forbes, J. F. (2014). 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. British journal of cancer, 111(1), 1-7. https://doi.org/10.1038/bjc.2014.144

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. et al.
In: British journal of cancer, Vol. 111, No. 1, 07.2014, p. 1-7.

Research output: Contribution to journal › Article › peer-review

Juraskova, I, Butow, P, Bonner, C, Bell, ML, Smith, AB, Seccombe, M, Boyle, F, Reaby, L, Cuzick, J & Forbes, JF 2014, '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', British journal of cancer, vol. 111, no. 1, pp. 1-7. https://doi.org/10.1038/bjc.2014.144

@article{855d6c32f365498c821d123359ac804b,

title = "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",

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.",

keywords = "International Breast Cancer Intervention Study-II (IBIS-II), clinical trial recruitment, decision aids, decisional conflict, informed consent, randomised controlled trial",

author = "I. Juraskova and P. Butow and C. Bonner and Bell, \{M. L.\} and Smith, \{A. B.\} and M. Seccombe and F. Boyle and L. Reaby and J. Cuzick and Forbes, \{J. F.\}",

note = "Funding Information: We thank all the participants, staff at the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) operations centre in Newcastle, Australia, and the principal investigators and trial coordinators at Armidale Base Hospital (Nick Pavlakis, Pamela Witten), Coffs Harbour Health Campus (Karen Briscoe, Joanne Smith), Newcastle Calvary Mater Hospital (John Forbes, Vicki Sproule), Royal Melbourne Hospital (A/Prof John Collins, Gillian Hoogeveen), Sir Charles Gairdner Hospital (Christobel Saunders, Suzanne Wegecsanyi), St Vincent{\textquoteright}s Hospital Melbourne (Raymond Snyder, Sarah Vickery), St Vincent{\textquoteright}s Hospital Sydney (Robyn Ward, Lynne Jolly), Tamworth Hospital (Elizabeth Hovey, Rebecca Hemmings, Margaret Chamen), The Breast Centre (David Clark, Judith Silcock), Waikato Hospital (Ian Campbell, Shelley Cavanagh), Liverpool Hospital (Chris Holcombe, Laura Francis), and Southampton Hospital (Ramsey Cutress, Kim Stevens, Julie Gwilt). We thank Joseph Coll and Daniel Costa for assistance with analyses.This study was supported by Susan G. Komen for the Cure (grant number BCTR0503961) and discretionary funding from the Breast Cancer Institute of Australia, which is the fundraising and education department of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG; no grant number). The funding bodies had no role in the writing of the manuscript or decision to submit it for publication. The authors were not paid by a pharmaceutical company or other agency to write this article. Dr Ilona Juraskova had full access to all the data in the study and had final responsibility for the decision to submit for publication. Australian New Zealand Clinical Trials Registry (ANZCTR) numbers are as follows: IBIS-II DA study: ACTRN126050005 06695, IBIS-II Prevention: ACTRN12605000216617 and IBIS-II DCIS: ACTRN12605000282684.",

year = "2014",

month = jul,

doi = "10.1038/bjc.2014.144",

language = "English (US)",

volume = "111",

pages = "1--7",

journal = "British journal of cancer",

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T1 - 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

AU - Juraskova, I.

AU - Butow, P.

AU - Bonner, C.

AU - Bell, M. L.

AU - Smith, A. B.

AU - Seccombe, M.

AU - Boyle, F.

AU - Reaby, L.

AU - Cuzick, J.

AU - Forbes, J. F.

N1 - Funding Information: We thank all the participants, staff at the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) operations centre in Newcastle, Australia, and the principal investigators and trial coordinators at Armidale Base Hospital (Nick Pavlakis, Pamela Witten), Coffs Harbour Health Campus (Karen Briscoe, Joanne Smith), Newcastle Calvary Mater Hospital (John Forbes, Vicki Sproule), Royal Melbourne Hospital (A/Prof John Collins, Gillian Hoogeveen), Sir Charles Gairdner Hospital (Christobel Saunders, Suzanne Wegecsanyi), St Vincent’s Hospital Melbourne (Raymond Snyder, Sarah Vickery), St Vincent’s Hospital Sydney (Robyn Ward, Lynne Jolly), Tamworth Hospital (Elizabeth Hovey, Rebecca Hemmings, Margaret Chamen), The Breast Centre (David Clark, Judith Silcock), Waikato Hospital (Ian Campbell, Shelley Cavanagh), Liverpool Hospital (Chris Holcombe, Laura Francis), and Southampton Hospital (Ramsey Cutress, Kim Stevens, Julie Gwilt). We thank Joseph Coll and Daniel Costa for assistance with analyses.This study was supported by Susan G. Komen for the Cure (grant number BCTR0503961) and discretionary funding from the Breast Cancer Institute of Australia, which is the fundraising and education department of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG; no grant number). The funding bodies had no role in the writing of the manuscript or decision to submit it for publication. The authors were not paid by a pharmaceutical company or other agency to write this article. Dr Ilona Juraskova had full access to all the data in the study and had final responsibility for the decision to submit for publication. Australian New Zealand Clinical Trials Registry (ANZCTR) numbers are as follows: IBIS-II DA study: ACTRN126050005 06695, IBIS-II Prevention: ACTRN12605000216617 and IBIS-II DCIS: ACTRN12605000282684.

PY - 2014/7

Y1 - 2014/7

N2 - 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.

AB - 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.

KW - International Breast Cancer Intervention Study-II (IBIS-II)

KW - clinical trial recruitment

KW - decision aids

KW - decisional conflict

KW - informed consent

KW - randomised controlled trial

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DO - 10.1038/bjc.2014.144

M3 - Article

C2 - 24892447

AN - SCOPUS:84904104089

SN - 0007-0920

VL - 111

SP - 1

EP - 7

JO - British journal of cancer

JF - British journal of cancer

IS - 1

ER -

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

Abstract

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