Grant Number:	1R01CA293927-01 Interpret this number
Primary Investigator:	Kukafka, Rita
Organization:	Columbia University Health Sciences
Project Title:	Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Racially/Ethnically Diverse Women at High Risk for Breast Cancer
Fiscal Year:	2024

Women with high-risk breast lesions, such as atypical hyperplasia (AH) and lobular carcinoma in situ (LCIS), have up to a 4- to 10-fold increased risk of invasive breast cancer (BC) compared to women with non-proliferative breast disease. Chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) have been shown in randomized controlled trials (RCTs) to reduce BC incidence by up to 50-65% among high-risk women, with a 70-80% relative risk reduction among women with AH or LCIS. However, chemoprevention uptake remains low at <15%. Cardiovascular disease (CVD) is also common in women, and HMG CoA reductase inhibitors, or “statins,” are used for primary prevention, with a relative risk reduction of ~25% for major vascular events. About half of eligible U.S. patients are currently on a statin for primary prevention of CVD. This contrasts with less than 15% of eligible high-risk women taking chemoprevention. While numerous studies have been conducted to elucidate the complexities in BC chemoprevention decision-making, no studies have been conducted within the context of preventive therapy for CVD. In this project, we will investigate where and why, on the patient's journey from understanding their risk to discussing risk-reducing medications with their provider, there is a divergence resulting in lower uptake of BC chemoprevention relative to the use of statins for CVD. Using iterative equity-focused human-centered design, we will uncover differences in the decision-making process (SERMs/AIs vs. statins), compare why a woman may opt out of SERMS/AIs as a preventive measure but opt-in for statins, and explore if women can benefit from calibrating the chemoprevention decision-making process in the context of more familiar statin preventive therapy for CVD. We developed and rigorously evaluated decision support tools, RealRisks for patients and BNAV for primary care providers (PCPs), in RCTs, to increase chemoprevention and genetic testing among high-risk women. In this proposal, we will refine these decision- support tools based on a deeper understanding of chemoprevention uptake in the context of preventive therapy for CVD. Our hypothesis is that the equity-focused human-centered design process, which is designed to enhance understanding of low adoption of chemoprevention by contrasting decision-making with that of individuals at risk of CVD, can clarify barriers and improve chemoprevention uptake. Specific aims are to 1) apply human-centered design to refine RealRisks and BNAV for BC and CVD; 2) conduct a cluster randomized trial with randomization of 60 PCPs to standard educational materials alone or combined with patient and provider decision support to improve chemoprevention uptake among 200 racially/ethnically high-risk women, age 40-74 years; and 3) conduct an equity-focused evaluation of intervention implementation. This proposal addresses a significant public health problem given the burden of BC and CVD mortality, particularly among racial/ethnic minorities. It has the potential to illuminate previously unaddressed barriers to chemoprevention decision-making in the context of interventions used to treat or prevent other chronic conditions, such as statins for CVD.





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