Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention

Abstract

Background Chemoprevention using selective estrogen receptor modulators and aromatase inhibitors has been shown to reduce invasive breast cancer incidence in high-risk women. Despite this evidence, few high-risk women who are eligible for chemoprevention utilize it as a risk-reducing strategy. Reasons for low uptake include inadequate knowledge about chemoprevention among patients and healthcare providers, concerns about side effects, time constraints during the clinical encounter, and competing comorbidities. Methods/design We describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer. The trial is being conducted at a large, urban medical center. A total of 300 patients and 50 healthcare providers will be recruited and randomized to standard educational materials alone or in combination with the decision support tools. Patient reported outcomes will be assessed at baseline, one and six months after randomization, and after their clinic visit with their healthcare provider. Discussion We are conducting this trial to provide evidence on how best to support personalized breast cancer risk assessment and informed and shared decision-making for chemoprevention. We propose to integrate the decision support tools into clinical workflow, which can potentially expand quality decision-making and chemoprevention uptake. Trial registration NCT03069742.

Perceptions of Racially and Ethnically Diverse Women at High Risk of Breast Cancer Regarding the Use of a Web-Based Decision Aid for Chemoprevention: Qualitative Study Nested Within a Randomized Controlled Trial

“…3. Recommendations for improvement: participants wanted more tailoring based on user characteristics. 4. Information needs: participants reported wanting to learn more about mammography screening and breast cancer risk factors, including modifiable lifestyle factors.…”

“…The United States Preventive Services Task Force recommends that clinicians offer chemoprevention as a primary prevention strategy to women at high risk of breast cancer and low risk of adverse effects from these drugs [3]. High-risk criteria for breast cancer are defined as a 5-year invasive breast cancer risk of ≥1.67% or lifetime risk score of ≥20% according to the Gail risk model, which accounts for age, race and ethnicity, benign breast disease, first-degree family history of breast cancer, and reproductive factors [4,5]. Chemopreventive agents such as selective estrogen receptor modulators (tamoxifen and raloxifene) and aromatase inhibitors (exemestane and anastrozole) have been shown to reduce breast cancer risk by 41%-79% among high-risk women [6].…”

“…Chemopreventive agents such as selective estrogen receptor modulators (tamoxifen and raloxifene) and aromatase inhibitors (exemestane and anastrozole) have been shown to reduce breast cancer risk by 41%-79% among high-risk women [6]. Despite the risk-reducing benefits, chemoprevention uptake remains low in the United States, with fewer than 5% of high-risk women deciding to take the medication [4]. Racial and ethnic minority women are less likely to seek breast cancer preventive care [7,8], which contributes to higher rates of late-stage diagnoses, poorer clinical outcomes, and health disparities [9][10][11].…”

“…However, these interventions have been met with limited success, ranging from 0.5% to 5.6% chemoprevention uptake [14,15,[18][19][20]. To address patient-related barriers to chemoprevention among racially and ethnically diverse women, our research team developed a patient-centered, web-based decision aid (DA), RealRisks, which is currently being tested in 3 clinical trials [4,21,22].…”

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

“…Third, our intervention was delivered at the patient level, and we did not target the physician, the clinical delivery system, or known barriers. Some ongoing studies are already evaluating chemoprevention uptake using dual patient- and physician-targeted education interventions with results forthcoming ( 42 ). Finally, our study randomly assigned women prior to informed consent, such that we could expedite participant access to study website at enrollment.…”