# Multicenter trial of decision support for breast cancer chemoprevention

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2020 · $690,977

## Abstract

Breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase
inhibitors (AIs) is underutilized, despite several randomized controlled trials demonstrating a 50-65% decrease
in breast cancer incidence among high-risk women. Women with atypical hyperplasia (AH) or lobular carcinoma
in situ (LCIS) have a 4- to 10-fold increased risk of breast cancer and derive up to a 70-80% relative risk reduction
with SERMs or AIs. Reasons for low chemoprevention uptake include inadequate time for counseling, insufficient
knowledge about SERMs and AIs, and concerns about side effects. We hypothesize that standard educational
materials combined with decision support tools will increase chemoprevention informed choice compared to
standard educational materials alone among women with AH or LCIS.
 We have developed web-based decision support tools, RealRisks for high-risk women and BNAV (Breast
cancer risk NAVigation tool) for healthcare providers. Our patient-centered decision aid, RealRisks, is available
in English and Spanish and has been rigorously tested in multi-ethnic high-risk women of varying health literacy,
numeracy, and acculturation. After exposure to these tools, we have demonstrated an improvement in accurate
breast cancer risk perceptions, chemoprevention knowledge and informed choice among multi-ethnic high-risk
women. Our objective is to integrate these tools into clinic workflow via the electronic health record (EHR) and
expand their use in a multicenter trial targeting women with AH or LCIS. To evaluate effectiveness (Aim 1) and
implementation (Aim 2), we will conduct a hybrid cluster-randomized trial at 40 sites of standard educational
materials combined with RealRisks and BNAV or standard educational materials alone among 384 women with
AH or LCIS. We will leverage the clinical trials infrastructure of the NCI Community Oncology Research Program
(NCORP), including minority/underserved sites. Our primary effectiveness endpoint is chemoprevention
informed choice at 6 months after enrollment (Aim 1). Secondarily, we will assess chemoprevention knowledge,
perceived breast cancer risk/worry, and decision conflict at baseline, 6 and 12 months, as well as shared
decision-making and chemoprevention uptake/adherence. For the implementation component of the trial (Aim
2), we will evaluate the impact of portal integration of the decision support tools using surveys and key informant
interviews of healthcare providers, including specialists and primary care providers, and high-risk women with
AH or LCIS to better understand barriers and facilitators to chemoprevention uptake. We will use the RE-AIM
(Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for the implementation evaluation.
 This proposal seeks to overcome important barriers to chemoprevention uptake among diverse women with
AH or LCIS, a population of high-risk women that is more likely to benefit from SERMs and AIs. Providing EHR-
integrated ...

## Key facts

- **NIH application ID:** 9828643
- **Project number:** 5R01CA226060-02
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Katherine D Crew
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $690,977
- **Award type:** 5
- **Project period:** 2018-12-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9828643

## Citation

> US National Institutes of Health, RePORTER application 9828643, Multicenter trial of decision support for breast cancer chemoprevention (5R01CA226060-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9828643. Licensed CC0.

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