InterventionResults from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer
Introduction
Recent evidence suggests that approximately 15% of women aged 30–84 in the United States (US), more than 11.5 million women, may be at high risk of breast cancer [1], based on the National Cancer Institute Breast Cancer Risk Assessment Tool (BCRAT) 5-year absolute risk estimate [2], [3]. For women who meet the high risk threshold of BCRAT 5-year risk ≥1.66% and are between the ages 40 and 74, the American Society of Clinical Oncology and National Comprehensive Cancer Network recommend that patients consider prophylactic treatment with tamoxifen or raloxifene to reduce the risk of invasive breast cancer in the future, although the latter is only recommended for postmenopausal women [4], [5]. However, the decision to use prophylactic chemoprevention can be overwhelming to women, especially since there is not a clear right or wrong decision. The best decision for each woman must take into account the balance of potential risks and benefits, as well as one's own values and preferences. Thus, it is considered a preference-sensitive decision [6].
Decision aids are designed to help individuals make specific and deliberate choices about their care by providing accurate, balanced information on the options and outcomes to prepare individuals for decision making [7]. Ideally, the decision aid should also help individuals clarify their own values and better inform their personal choices [8]. Decision aids have been shown to increase individuals’ knowledge of their options, provide evidence-based information about a health condition and the associated uncertainties, help patients recognize the value-sensitive nature of decisions, guide patients to consider which benefits and harms are most important to them, increase individuals’ comfort with their personal choice, improve patient-provider communication about options, provide guidance in the steps of decision making and communication of their values, and enable patients to be active, informed participants [7], [9].
The purpose of this study was to assess the impact of Guide to Decide (GtD) a web-based, personally tailored decision aid developed to inform women at high risk of breast cancer about the risks and benefits of prophylactic tamoxifen and raloxifene use [10]. The International Patient Decision Aid Standards (IPDAS) Collaboration suggests that the primary measure for evaluating patient decision aids should be decision quality, defined as the extent to which a patient's decision is informed and based on personal values. Furthermore, IPDAS recommended the need to assess patients’ recognition that a decision needs to be made, appreciation of one's goals and values, and the importance of values in the decision [11]. Subsequently, to assess these key concepts of the patient decision making process, we aimed to evaluate the impact of the Guide to Decide on decisional conflict and treatment decision behavior (primary outcomes), and the association between these outcomes with patient satisfaction with the decision aid and preparation for decision making (secondary outcomes).
We hypothesized that the odds of having made a decision about whether or not to take prophylactic tamoxifen or raloxifene, at 3-month follow-up, would be higher among women who received the GtD; additionally, that women who received the GtD would report higher levels of post-test decisional conflict, since it is likely that these women would be unaware of their increased risk of developing breast cancer or the chemopreventive options prior to receiving the GtD. Further, we hypothesized that higher decisional conflict levels would be associated with lower patient satisfaction with the decision aid, and that higher levels of preparation for decision would be associated with higher odds of having made a decision about whether prophylactic tamoxifen or raloxifene, at 3-month follow-up.
Section snippets
Study design and intervention
Information about the study design, recruitment, study population and intervention has been previously described in detail [10]. In brief, upon obtaining IRB approval from the University of Michigan and the two recruiting sites, women at high risk of breast cancer (based on the National Cancer Institute Breast Cancer Risk Assessment Tool (BCRAT) 5-year risk ≥1.66%) were recruited from Group Health Cooperative (Seattle, WA) and the Henry Ford Health System (Detroit, MI) between August 2007 and
Participants’ baseline characteristics and response rates
Participants’ baseline demographic characteristics are described in Table 1. Intervention and control group participants were similar in age, race/ethnicity, educational attainment and BCRAT 5-year risk score at baseline. In general, participants were predominately non-Hispanic White (96.1%) and well-educated (65% with a bachelor's degree or higher), with a mean age of 61.8 years (standard deviation (SD) = 5.2) and mean BCRAT 5-year risk of 2.6% (SD = 1.2).
Overall, 1039 women provided informed
Discussion
We found that women who received the GtD decision aid had greater odds of making a decision or were closer to making a decision about whether to take prophylactic tamoxifen or raloxifene than women who did not receive the decision aid. Furthermore, contrary to our hypotheses, women in the intervention group had significantly lower decisional conflict levels. In fact, mean decisional conflict scores among women receiving the decision aid were less than half that of Time 1 control participants
Competing interests
None declared.
Acknowledgements
Financial support for this study was provided by a grant from the National Institutes for Health (P50 CA101451) and registered as ClinicalTrials.gov Identifier: NCT00967824. M.P. Banegas was supported, in part, by the National Cancer Institute Biobehavioral Cancer Prevention and Control Training Program (R25CA092408) at the University of Washington and the National Cancer Institute Center for Hispanic Health Promotion Training Program (1U54CA153502-01) at the Fred Hutchinson Cancer Research
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2017, Women's Health IssuesCitation Excerpt :Scores less than 25 are associated with implementing a decision and can be considered low conflict; scores greater than 37.5 are associated with decision delay or feeling unsure about implementation (O'Connor, 1993) and can be considered highly conflicted and possibly of clinical concern, that is, needing additional counseling and education to assist them in making a decision (Parayre, Labrecque, Rousseau, Turcotte, & Légaré, 2013). The DCS has been used in studies of decision making regarding prenatal testing (Caleshu, Shiloh, Price, Sapp, & Biesecker, 2010), breast cancer treatment (Banegas et al., 2013; King et al., 2013), vasectomy (Labrecque, Paunescu, Plesu, Stacey, & Legare, 2010), and bariatric surgery (Schauer et al., 2014), among others. In previously published analyses of this dataset, we found the DCS to be appropriate for use in women seeking abortion.