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

• Main Authors: Katherine D. Crew, Thomas B. Silverman, Alejandro Vanegas, Meghna S. Trivedi, Jill Dimond, Jennie Mata, Margaret Sin, Tarsha Jones, Mary Beth Terry, Wei-Yann Tsai, Rita Kukafka
• Format: Article
• Language: English
• Published: Elsevier 2019-12-01
• Series: Contemporary Clinical Trials Communications
• Online Access: http://www.sciencedirect.com/science/article/pii/S2451865419301954

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. Keywords: Breast cancer risk, Chemoprevention, Decision support