This project entails multi-phased experimental process to explore methods of communicating risk regarding tamoxifen prophylaxis to women at high risk for breast cancer.

breast cancer, cancer prevention, tamoxifen, raloxifene, prophylaxis, decision aid, risk communication, tailoring, Internet, web

Phase I:

1. Develop and test a tamoxifen prophylaxis decision aid by screening three risk messages and three graphical formats using fractional factorial designs.
2. Screen for individual characteristics (e.g., ability to think numerically) that will point the way towards methods of improving decision aids by tailoring risk messages.
3. Test two novel methods of evaluating whether decision aids improve decisions.

Phase II:

1. Refine our understanding of the factors that increase the effectiveness of the decision aid in Phase I, by isolating specific components of those factors.
2. Refine and further explore promising interactions between risk messages/graphical formats and specific individual characteristics.
3. Determine whether improved knowledge of the risks and benefits of tamoxifen translates into behavioral outcomes such as consulting with a physician.

1,184 women in two Cancer Research Network HMOs.

Phase I
In Phase I, we designed a web-based decision aid for women at an increased risk of developing breast cancer that discussed the risks and benefits of taking tamoxifen to prevent a first breast cancer. A screening experiment was conducted, using a fractional factorial design, to test the effect of various risk messages and graphical formats on women's risk perceptions and decisions regarding tamoxifen prophylaxis. All risk information was tailored to the individual women based on their personal risk of breast cancer according to the Gail model.

Phase I tested the following factors:

1. Pictographs to display risk information (present versus absent)
2. Statistics: Simple (out of 100 women, no relative risk) versus elaborate (out of 1000 women, presence of relative risk)
3. Risk presentation (additional risk [incremental increase/decrease in risk] versus total risk)
4. Order (risk information first versus benefit information first)
5. Risk context (information about other health risks-present versus absent)

We recruited a total of 644 subjects from two HMOs - Henry Ford Health System in Detroit and Group Health in Seattle.

Phase II
As Phase I recruited its last subjects, the National Cancer Institute released the findings of the clinical trial called the Study of Tamoxifen and Raloxifene (STAR). The results of the STAR trial indicated that tamoxifen and a newer drug, raloxifene, are equally effective in preventing a first occurrence of breast cancer in postmenopausal women at increased risk of developing it. As most experts now contended that both drugs would be viable alternatives for the primary prevention of breast cancer, we felt compelled to include both tamoxifen and raloxifene in our Phase II decision aid. The other major change from our Phase II protocol was the addition of control groups, which will allow us to test the impact of not receiving a Decision Aid on knowledge, risk perception, and behavior at baseline and after 3 months. We are concerned, however, that even limited exposure to mention of tamoxifen and raloxifene (which is included in our survey) will prompt some women to independently research these medications. Thus, we have split the control condition into 2 groups - one of which will not be asked any questions about tamoxifen and raloxifene during the baseline survey and one which will.

In Phase II, approximately 640 women (roughly 2/3 of total enrolled) will be randomly assigned to the Intervention group, and will receive the Decision Aid, an individually-tailored program based on combinations of five tailoring factors (described below) at baseline. Results from Phase I and new clinical research results from the STAR trial have helped us to identify new factors to guide our research in Phase II.

1. Order - whether participants receive information on risks of chemoprevention first or information on benefits of chemoprevention first.
2. Describing decision as having 2 vs. 3 treatment options - whether participants receive an assessment of benefits and risk in terms of no medications vs. medications, or no medications vs. tamoxifen vs. raloxifene.
3. All About You (AAY) - Personalization and Testimonials - whether participants receive testimonials written from the viewpoint of individuals who have or have not used chemoprevention, as well as testing using 2nd person vs. 3rd person voice. The testimonials will describe how the woman in the testimonial (who will be age and race matched to the subject) used the decision aid to help her make her decision.
4. Comparative risk information - whether participants receive information on the average woman's risk of breast cancer in addition to their own personal risk.
5. Summary table - whether participants receive all the information on risks and benefits in table form after receiving the same information as text and pictographs.

Phase I Findings

• Women have very little interest in looking for more information about tamoxifen, talking with their doctor about tamoxifen, or taking tamoxifen to prevent a first diagnosis of breast cancer.
• Women's lack of interest in tamoxifen is largely due to their perception of the risks of tamoxifen, particularly in that they do not view the benefits of tamoxifen are worth the risks associated with taking it.
• Women's comparative risk perceptions were more important than their objective risk in predicting responses to a decision aid about tamoxifen (e.g., their anxiety, knowledge, and behavior).
• Higher comparative risk perceptions were associated with more anxiety about breast cancer, more knowledge about the risks and benefits of tamoxifen, greater intentions to take action, and three months later, engaging in behaviors consistent with an interest in taking tamoxifen.
  
• The order in which the risks and benefits of a medication are presented has a significant impact on people’s risk perceptions, knowledge, and behavior. When risks are presented last, people are more worried about the side effects of the medication and perceive them as more likely. The information presented last is remembered better. When risks are presented last, people are less interested in the medication.
• Pictographs make risk statistics easier to interpret, eliminating biases caused by other design factors.
• When using pictographs to present risk and benefit information, it is best to present information using an incremental risk format.
• A measure of subjective numeracy is a good predictor of health communication predictor and has similar predictive ability as an objective numeracy measure.

Phase II Findings
Study still in progress.

Phase I Conclusion
How you present information to patients has a significant impact on their decision making. When designing decision aids, it is extremely important to consider how to present the risks and benefits of treatment options. Our findings have led us to recommend using pictographs and incremental risk format to communicate the additional risk a patient is exposed to due to a medical intervention. Furthermore, the order in which individuals discuss the risks and benefits of treatment has a substantial impact on knowledge and treatment preferences.

Women have very low interest in taking tamoxifen to prevent a first diagnosis of breast cancer. This is primarily due to their concerns regarding the side effects of tamoxifen. Furthermore, women do not view the benefits of tamoxifen worth the risks of taking tamoxifen.

Phase II Conclusion
Study still in progress.

All studies below were used to design Phase I or Phase II (pilot studies) or are the result of Phase I.<br><br>

Fagerlin A, Zikmund-Fisher BJ, Ubel PA. How making a risk estimate can change the feel of that risk: Shifting attitudes toward breast cancer risk in a general public survey. Patient Education and Counseling 2005 Jun;57(3):294-299. <br><br>

Zikmund-Fisher BJ, Fagerlin A, Ubel PA. What's time got to do with it? Inattention to duration in interpretation of survival graphs. Risk Analysis 2005;25(3):589-595. DOI: 10.1111/j.1539-6924.2005.00626.x <br><br>

Fagerlin A, Zikmund-Fisher BJ, Ubel PA. “If I'm better than average, then I'm ok"?: Comparative information influences beliefs about risk and benefits. Patient Education and Counseling 2007;69:140-144. DOI:10.1016/j.pec.2007.08.008<br><br>

Amsterlaw J, Zikmund-Fisher BJ, Fagerlin A, & Ubel PA. Can fear of complications lead to bad decisions? Evidence of a persistent new bias in healthcare decision-making. Judgment and Decision Making, 1 (1):64-75, 2006.<br><br>

Zikmund-Fisher BJ, Sarr B, Fagerlin A, Ubel PA. A matter of perspective: choosing for others differs from choosing for yourself in making treatment decisions. Journal of General Internal Medicine, 21(6):618-22, 2006.<br><br>

Fagerlin, A., Zikmund-Fisher, B.J., Ubel, P.A., Jankovic, A., Derry, H.A., & Smith, D.M. Measuring numeracy without a math test: Development of the Subjective Numeracy Scale (SNS). Medical Decision Making, 2007: 27: 672-680.<br><br>

Zikmund-Fisher, B.J., Smith, D.M., Ubel, P.A., Fagerlin, A. Validation of the subjective numeracy scale (SNS): Effects of low numeracy on comprehension of risk communications and utility elicitations. Medical Decision Making, 2007: 27: 663-671.<br><br>

Fagerlin, A., Ubel, P.A., Smith. D.M., Zikmund-Fisher, B.J. Making numbers matter: Present and future research in risk communication. American Journal of Health Behavior. 2007: 31 (Suppl 1): S47-56.<br><br>

Zikmund-Fisher BJ, Fagerlin A, Roberts TR, Derry HA, Ubel PA. Alternate methods of framing information about medication side effects: Incremental risk versus total risk of occurrence. Journal of Health Communication. (In Press)<br><br>

Nair, V., Strecher, J., Fagerlin A., Ubel, P.A. Resnicow, K., Murphy, S., Little, R., Chakraborty, B., & Zhang, A. Screening experiments and fractional factorial designs in behavioral intervention research. In Press.<br><br>

Fagerlin, A., Zikmund-Fisher, B.J., Smith, D.M., Nair, V., Derry, H.A., McClure, J.B., Greene, S., Stark, A. Hensely Alford, S., Lantz, P., Hayes, D.F., Wiese, C., Claud Zweig, S., Pitsch, R.K., Janovic, A., Ubel, P.A. Patients’ decisions regarding tamoxifen for breast cancer prevention: Responses to a tailored decision aid. In submission.<br><br>

Zikmund-Fisher, B.J., Ubel, P.A., Smith, D.M., Derry, H.A., McClure, J.B., Stark, A., Pitsch, R.K., Fagerlin, A. Communicating side effect risks in a tamoxifen prophylaxis decision aid: The debiasing influence of pictographs. In submission.