Effect of Personalized Breast Cancer Risk Tool on Chemoprevention and Breast Imaging: ENGAGED-2 Trial

Abstract

Background Limited evidence exists about how to communicate breast density-informed breast cancer risk to women at elevated risk to motivate cancer prevention. Methods We conducted a randomized controlled trial evaluating a web-based intervention incorporating personalized breast cancer risk, information on chemoprevention, and values clarification on chemoprevention uptake vs active control. Eligible women aged 40-69 years with normal mammograms and elevated 5-year breast cancer risk were recruited from Kaiser Permanente Washington from February 2017 to May 2018. Chemoprevention uptake was measured as any prescription for raloxifene or tamoxifen within 12 months from baseline in electronic health record pharmacy data. Secondary outcomes included breast magnetic resonance imaging (MRI), mammography use, self-reported distress, and communication with providers. We calculated unadjusted odds ratios (ORs) using logistic regression models and mean differences using analysis of covariance models with 95% confidence intervals (CIs) with generalized estimating equations. Results We randomly assigned 995 women to the intervention arm (n = 492) or control arm (n = 503). The intervention (vs control) had no effect on chemoprevention uptake (OR = 1.04, 95% CI = 0.07 to 16.62). The intervention increased breast MRI use (OR = 5.65, 95% CI = 1.61 to 19.74) while maintaining annual mammography (OR = 0.98, 95% CI = 0.75 to 1.28). Women in the intervention (vs control) arm had 5.67-times higher odds of having discussed chemoprevention or breast MRI with provider by 6 weeks (OR = 5.67, 95% CI = 2.47 to 13.03) and 2.36-times higher odds by 12 months (OR = 2.36, 95% CI = 1.65 to 3.37). No measurable differences in distress were detected. Conclusions A web-based, patient-level intervention activated women at elevated 5-year breast cancer risk to engage in clinical discussions about chemoprevention, but uptake remained low.

Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial

“…One year post-intervention, we found no improvement in uptake of risk-reducing medication due to the intervention. However, among women with ≥ 2.50% 5-year risk for breast cancer, we did observe 4.5-fold increased odds of receipt of breast MRI in the intervention arm compared to the control arm [11]. The null intervention results may be due to the time frame in which outcomes were assessed (1 year following intervention delivery).…”

“…A randomized controlled trial compared the PMTinformed intervention to a control arm that directed participants to relevant online health information [10,11]. One year post-intervention, we found no improvement in uptake of risk-reducing medication due to the intervention.…”

“…The sample was primarily non-Hispanic White (95%), in middle adulthood (M = 62 years, range = 40-69), with a college degree or greater (74%) and an annual household income ≥ $70,001 (56%) (see prior descriptions of this sample [10,11]). The majority of the women were pre-menopausal (93%).…”

“…Our relatively short follow-up time frame (6 weeks) may have limited participants' ability to utilize these strategies. We have previously reported that the proportion of women in the intervention group who had "discussions" with their healthcare providers about risk-reducing medication increased substantially from the 6-week follow-up (5%) to the 12-month follow-up (14%) [11]. Thus, at the 6-week follow-up, participants' selfefficacy for risk-reducing medication may have reflected the educational components of the intervention, which provided detailed information about tamoxifen and raloxifene.…”

“…This two-arm randomized controlled trial (ENGAGED-2, ClinicalTrials.gov identifier: NCT03029286) has been described in detail elsewhere [10,11]. The trial was approved by the Georgetown University Institutional Review Board (IRB #2015-0687).…”