Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Jan 14;5(1):pkaa114.
doi: 10.1093/jncics/pkaa114. eCollection 2021 Feb.

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

Karen J Wernli  1 , Sarah Knerr  2 , Tengfei Li  3 , Kathleen Leppig  4 , Kelly Ehrlich  1 , David Farrell  5 , Hongyuan Gao  1 , Erin J A Bowles  1 , Amanda L Graham  6 , George Luta  3 , Jinani Jayasekera  7 , Jeanne S Mandelblatt  7 , Marc D Schwartz  7 , Suzanne C O'Neill  7
Affiliations
Randomized Controlled Trial

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

Karen J Wernli et al. JNCI Cancer Spectr. .

Abstract

Background: Limited evidence exists about how to communicate breast density-informed breast cancer risk to women at elevated risk to motivate cancer prevention.

Methods: We conducted a randomized controlled trial evaluating a web-based intervention incorporating personalized breast cancer risk, information on chemoprevention, and values clarification on chemoprevention uptake vs active control. Eligible women aged 40-69 years with normal mammograms and elevated 5-year breast cancer risk were recruited from Kaiser Permanente Washington from February 2017 to May 2018. Chemoprevention uptake was measured as any prescription for raloxifene or tamoxifen within 12 months from baseline in electronic health record pharmacy data. Secondary outcomes included breast magnetic resonance imaging (MRI), mammography use, self-reported distress, and communication with providers. We calculated unadjusted odds ratios (ORs) using logistic regression models and mean differences using analysis of covariance models with 95% confidence intervals (CIs) with generalized estimating equations.

Results: We randomly assigned 995 women to the intervention arm (n = 492) or control arm (n = 503). The intervention (vs control) had no effect on chemoprevention uptake (OR = 1.04, 95% CI = 0.07 to 16.62). The intervention increased breast MRI use (OR = 5.65, 95% CI = 1.61 to 19.74) while maintaining annual mammography (OR = 0.98, 95% CI = 0.75 to 1.28). Women in the intervention (vs control) arm had 5.67-times higher odds of having discussed chemoprevention or breast MRI with provider by 6 weeks (OR = 5.67, 95% CI = 2.47 to 13.03) and 2.36-times higher odds by 12 months (OR = 2.36, 95% CI = 1.65 to 3.37). No measurable differences in distress were detected.

Conclusions: A web-based, patient-level intervention activated women at elevated 5-year breast cancer risk to engage in clinical discussions about chemoprevention, but uptake remained low.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
CONSORT diagram
Figure 2.
Figure 2.
Webpage content of ENGAGED-2 intervention displaying participant’s personalized breast cancer risk
Figure 3.
Figure 3.
Webpage content of ENGAGED-2 intervention of values clarification from participants
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Kinsinger LS, Harris R, Woolf SH, Sox HC, Lohr KN.. Chemoprevention of breast cancer: a summary of the evidence for the US Preventive Services Task Force. Ann Intern Med. 2002;137(1):59-69. - PubMed
    1. Nelson HD, Fu R, Humphrey L, Smith B, Griffin JC, Nygren P. Comparative effectiveness of medications to reduce risk of primary breast cancer in women. Ann Intern Med. 2009;151(10):703-15, W-226-35. - PubMed
    1. Nelson HD, Fu R, Zakher B, Pappas M, McDonagh M.. Medication use for the risk reduction of primary breast cancer in women: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;322(9):868-886. - PubMed
    1. Owens DK, Davidson KW, Krist AH, et al.; US Preventive Services Task Force. Medication use to reduce risk of breast cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2019;322(9):857-867. - PubMed
    1. Pinsky PF, Miller E, Heckman-Stoddard B, Minasian L.. Use of raloxifene and tamoxifen by breast cancer risk level in a Medicare-eligible cohort. Am J Obstet Gynecol. 2018;218(6):606.e601-606.e609. - PMC - PubMed

Publication types

MeSH terms