Women who learn that they carry a BRCA1/2
mutation are faced with a complex and emotion-laden decision about how to manage their risk for breast cancer (Schwartz, Peshkin, Tercyak, Taylor, & Valdimarsdottir, 2005
). Given the lack of definitive guidance, the decision about whether or not to obtain RRM must be made based on individual values. In this study, we tested a computer-based interactive DA designed to help BRCA1/2
mutation carriers make this decision. We found that the DA did not benefit the 48% of mutation carriers who had reached a management decision prior to randomization (i.e., within one month of receiving their test result). In contrast, the DA was highly effective among women who were undecided about how to manage their risk. For these women, the DA led to significant increases in the odds of reaching a management decision, increased satisfaction and decreased decisional conflict. These effects were consistent across the 12-month follow-up period, suggesting that the DA improved both short- and long-term decision making within this group.
The fact that about half of the study participants had already decided how to manage their risk within a month of testing was unexpected. Because the decision about whether or not to obtain a RRM is not typically time sensitive, we anticipated that most carriers would still be considering their options at the time of randomization. However, our finding that the DA was most effective among those who were undecided is consistent with previous research (O’Connor et al., 1999
; O’Connor et al., 2003
). For example, a decision aid for newly diagnosed breast cancer patients led to reduced decisional conflict only among undecided patients (Goel et al., 2001
). Thus, our results along with previous studies strongly suggest that decision aids have their greatest impact among those individuals who are having the greatest difficulty reaching a decision.
Importantly, by 12-months post-randomization DA participants who were initially undecided fared about as well as participants who had quickly reached a decision. The only group that fared significantly worse was the UC participants who were undecided at randomization. For this group, decisional conflict remained high and decision satisfaction low. Further, only about half of this group had reached a management decision by the 12-month follow-up. Given their high degree of decisional conflict and uncertainty, this group could be at risk for adverse psychosocial and behavioral outcomes (Gattellari & Ward, 2005
; O’Connor, 1995
). Interestingly, women who quickly reached a decision did not benefit at all from added decision support. This raises the possibility that the decisions quickly reached by these women were effective and of high quality despite the apparent lack of deliberation. Of course it is also possible that these women simply modified their attitudes in order to reflect the decision that they had already made.
The low overall rate of RRM in this study is consistent with previous reports documenting low uptake of RRM following testing (Peshkin et al., 2002
; Botkin et al., 2003
). The DA did not impact on the rate of RRM across the two groups, nor was the impact of the DA on RRM modified by initial management decision status. However, the DA did impact the timing of RRM. Women randomized to UC were more likely to have a RRM prior to the 1-month follow-up assessment. In contrast, women in the DA group were more likely to obtain a RRM between 6 and 12 months post-disclosure. Although only speculation, this could indicate that the DA led to more deliberation prior to obtaining a RRM. This would be consistent with a central goal of decision aids to foster deliberative decision making. Importantly, since the RRM decision is not time sensitive, deliberative decision making may be particularly beneficial in this context. Future research should examine whether decision aids do in fact lead to increased deliberation and whether extra deliberation leads to improved outcomes.
The results of this trial contrast to the earlier randomized trial evaluating a post-disclosure decision aid for mutation carriers. The prior report focused on an in-person, multi-session shared decision making intervention that was delivered approximately two months following testing (van Roosmalen et al., 2004a
). Similar to the present study, the DA did not impact on rates of RRM, but did lead to stronger overall treatment preferences. This is comparable to our finding that the DA led to an increased likelihood of reaching a final decision. It is not clear from the prior report whether the DA had a differential effect among carriers who were undecided about management at the time of the intervention.
The results described here strongly suggest that BRCA1/2
mutation carriers can benefit from additional decision support following the receipt of test results. This is consistent with previous studies that have demonstrated benefits for decision aids delivered before (Green et al., 2004
; Wakefield et al., 2007
), during (van Roosmalen et al., 2004b
), and after genetic counseling (van Roosmalen et al., 2004a
). However, our study suggests that such decision aids may be of most benefit to those women who are having difficulty reaching a decision. Unlike prior trials among BRCA1/2
carriers (van Roosmalen et al., 2004a
), our results demonstrate the potential benefits of a DA used at home rather than in the clinic. This is consistent with studies of women considering BRCA1/2
testing in which a decision aid delivered at home was found to be effective (Wakefield et al., 2007
). Advantages to home use include greater disseminability and the possibility of patients using the DA on their own schedule and as many times as they wish. At home decision aids may be most beneficial for decisions that are less time sensitive. Finally, these data indicate that a substantial proportion of BRCA1/2
mutation carriers have ongoing difficulty making management decisions despite extensive genetic counseling. For many, these difficulties extend out to more than a year following the receipt of genetic test results. Although the long-term implications of these difficulties remain to be seen, it is clear from the data reported here that these difficulties can largely be ameliorated through effective adjunct decision support interventions.
This study has several limitations. Although the overall sample size of the trial was adequate, only 33 participants opted for RRM. Thus, the study was underpowered to detect effects on overall rates of RRM. Another limitation of the study was our inability to ensure that all participants in the DA group actually viewed the CD. In fact, about one-third of participants reported that they did not view the CD. When this variable was considered in multivariate models, the results did not change substantively (data not shown). Still, given this rate of noncompliance, our use of an intent to treat approach likely underestimated the impact of the DA among those who used it. A related concern was the fact that we did not track usage patterns of the CD. Thus, we do not know whether certain sections of the DA were particularly beneficial. In future studies we will use internet-based approaches to monitor DA usage patterns. Finally, the lack of diversity of the study sample limits the generalizability of these results. In particular, the vast majority of study participants had access to a home computer on which they could view the DA. Although laptop computers were available for loaning to participants who did not have computer access, only one participant required such a loan. Thus, whether these results could be replicated among lower SES participants with less universal computer access remains a question.
Despite these limitations, the present report demonstrates that BRCA1/2 mutation carriers who are having difficulty deciding upon a breast cancer risk management approach can benefit from adjunct decision support in the form of an interactive decision aid. Future research should determine the optimal timing of this decision aid relative to the receipt of test results and evaluate the possibility of more widespread dissemination of this or other decision aids for BRCA1/2 mutation carriers.