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Contemp Clin Trials Commun. 2019 Aug 22;16:100433. doi: 10.1016/j.conctc.2019.100433. eCollection 2019 Dec.

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

Author information

1
Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
2
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
3
Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY, USA.
4
Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
5
Sassafras Tech Collective, Ann Arbor, MI, USA.
6
Christine E Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL, USA.
7
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
8
Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.

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.

KEYWORDS:

Breast cancer risk; Chemoprevention; Decision support

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