Trial Information

Developing and Testing a Tamoxifen Prophylaxis Decision Aid

OBJECTIVES:

- To develop and test a decision aid for describing the risks and benefits of taking
tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast
cancer.

OUTLINE:

- Phase I: Patients are randomized to view 1 of 16 decision aids that vary in terms of
how the information is presented based on 5 dimensions: 1) statistical information in
pictographs vs plain text, 2) risk information presented with denominators of 100 vs
1000, 3) risk information presented in terms of total vs additional risk, 4) whether
the risks of tamoxifen citrate are presented before or after the benefits are
presented, and 5) contextual information about other risks the patient faces (all cause
mortality, colon cancer, heart attack).

Patients complete baseline and post-test questionnaires.

- Phase II: Patients are randomized to 1 of 3 arms.

- Arm I (control): Patients do not view the decision aid, but complete baseline and
post-test questionnaires.

- Arm II (control): Patients complete a baseline questionnaire only. They do not
view the decision aid or complete the post-test questionnaire.

- Arm III (intervention): Patients view 1 of 16 decision aids that vary based on 5
factors: 1) providing (or not) comparative information about the average woman's
breast cancer risk, 2) sequencing presentation of risks and benefits (risks first
vs benefits first), 3) including (or not) a summary table following presentation
of risks and benefits, 4) using second vs third person language ("your risk" vs "a
person like you"), and 5) presenting the decision as having 2 vs 3 options
(taking/not taking a breast cancer prevention drug vs taking tamoxifen
citrate/raloxifene, or no drug). Patients also complete baseline and post-test
questionnaires.

Patients in both phases complete an online follow-up survey at 3 months. Patients in arms I
or II (of phase II) receive a decision aid after completion of the follow-up survey.