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

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.

Figures

Figure 1
Figure 1
Recruitment flowchart: total (Prevention/DCIS).

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.
    1. Brehaut JC, Saginur R, Elwyn G. Informed consent documentation necessary but not sufficient. Contemp Clin Trials. 2009;30:388–389.
    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.
    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.
    1. Cohen J. A Power Primer. Psychol Bull. 1992;112:155–159.
    1. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21:830–835.
    1. Cuzick J. IBIS II: a breast cancer prevention trial in postmenopausal women using the aromatase inhibitor anastrozole. Expert Rev Anticancer Ther. 2008;8:1377–1385.
    1. Fallowfield LJ, Jenkins V, Brennan C, Sawtell M, Moynihan C, Souhami RL. Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer. 1998;34:1554–1559.
    1. Feldman-Stewart D, Tong C, Siemens R, Alibhai S, Pickles T, Robinson J, Brundage MD. The impact of explicit values clarification exercises in a patient decision aid emerges after the decision is actually made: evidence from a randomized controlled trial. Med Decis Making. 2012;32:616–626.
    1. Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996;16:58–64.
    1. International Patient Decision Aid Standards Collaboration 2005. Criteria for Judging the Quality of Patient Decision Aid Standards. Available at .
    1. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9:485–493.
    1. Jenkins VA, Fallowfield LJ, Souhami A, Sawtell M. How do doctors explain randomised clinical trials to their patients. Eur J Cancer. 1999;35:1187–1193.
    1. Jenkins V, Farewell D, Batt L, Maughan T, Branston L, Langridge C, Parlour L, Farewell V, Fallowfield L. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103:1801–1807.
    1. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772–1777.
    1. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of Informed Consent: a New Measure of Understanding Among Research Subjects. J Natl Cancer Inst. 2001;93:139–147.
    1. Juraskova I, Bonner C. Decision aids for breast cancer chemoprevention. Breast Cancer Res. 2013;15:106.
    1. Juraskova I, Butow P, Lopez AL, Seccombe M, Boyle F, McCarthy N, Forbes JF. Improving informed consent in clinical trials: Successful piloting of a decision aid. J Clin Oncol. 2007;25:1443–1444.
    1. Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS) Health Expectations. 2008;11:252–262.
    1. King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11:171–184.
    1. Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG.2013Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures Cochrane Database Syst Rev 7doi:10.1002/14651858.CD009445.pub2
    1. Loh WY, Butow PN, Brown RF, Boyle F. Ethical communication in clinical trials - Issues faced by data managers in obtaining informed consent. Cancer. 2002;95:2414–2421.
    1. Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) Br J Clin Psychol. 1992;31:301–306.
    1. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001;4:99–108.
    1. O'Brien MA, Whelan TJ, Villasis-Keever M, Gafni A, Charles C, Roberts R, Schiff S, Cai W. Are cancer-related decision aids effective? A systematic review and meta-analysis. J Clin OncolO. 2009;27:974–985.
    1. O'Connor A. Validation of a decisional conflict scale. Med Decis Making. 1995;15:25–30.
    1. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: What it is and what it isn't—It's about integrating individual clinical expertise and the best external evidence. Br Med J. 1996;312:71–72.
    1. Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13:S12.
    1. Sharp M. Consent documents for oncology trials: does anybody read these things. Am J Clin Oncol. 2004;27:570–575.
    1. Stacey D, Légaré F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;1:CD001431.
    1. Stepan KA, Gonzalez AP, Dorsey VS, Frye DK, Pyle ND, Smith RF, Throckmorton TA, Villejo LA, Cantor SB. Recommendations for enhancing clinical trials education: a review of the literature. J Cancer Educ. 2011;26:64–71.
    1. Sundaresan P, Turner S, Kneebone A, Pearse M, Butow P. Evaluating the utility of a patient decision aid for potential participants of a prostate cancer trial (RAVES-TROG 08.03) Radiother Oncol. 2011;101:521–524.
    1. Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials. 2004;1:368.

Source: PubMed

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