title: Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.
abstract: BACKGROUND
  Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.
  
  
  METHODS
  We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.
  
  
  RESULTS
  Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.
  
  
  CONCLUSIONS
  The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00967824
authors.forename: Ida J
authors.initials: IJ
authors.lastname: Korfage
authors.forename: Andrea
authors.initials: A
authors.lastname: Fuhrel-Forbis
authors.forename: Peter A
authors.initials: PA
authors.lastname: Ubel
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Zikmund-Fisher
authors.forename: Sarah M
authors.initials: SM
authors.lastname: Greene
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: McClure
authors.forename: Dylan M
authors.initials: DM
authors.lastname: Smith
authors.forename: Sharon Hensley
authors.initials: SH
authors.lastname: Alford
authors.forename: Angela
authors.initials: A
authors.lastname: Fagerlin
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000517:prevention & control*; D018890:Chemoprevention; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D005500:Follow-Up Studies; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D020407:Internet; D008875:Middle Aged; D011292:Premedication; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D013629:Tamoxifen / Q000008:administration & dosage
chemical_list: D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; D020849:Raloxifene Hydrochloride