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Randomized Controlled Trial
. 2021 Nov;30(11):1529-1537.
doi: 10.1089/jwh.2021.0053. Epub 2021 Sep 28.

Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density

Affiliations
Randomized Controlled Trial

Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density

Erin J Aiello Bowles et al. J Womens Health (Larchmt). 2021 Nov.

Abstract

Background: Breast density increases breast cancer risk and decreases mammographic detection. We evaluated a personalized web-based intervention designed to improve breast cancer risk communication between women and their providers. Materials and Methods: This was a secondary outcome analysis of an online randomized trial. Women aged 40-69 years were randomized, February 2017-May 2018, to a control (n = 503) versus intervention website (n = 492). The intervention website included information about breast density, personalized breast cancer risk, chemoprevention, and magnetic resonance imaging. Participants self-reported communication about density with providers (yes/no) at 6 weeks and 12 months. We used logistic regression with generalized estimating equations to evaluate the association of study arm with density communication. In secondary analyses, we tested if the intervention was associated with indicators of patient activation (breast cancer worry, perceived risk, or health care use). Results: Women (mean age 62 years) in the intervention versus control arm were 2.39 times (95% confidence interval [CI] = 1.37-4.18) more likely to report density communication at 6 weeks; this effect persisted at 12 months (odds ratio [OR] = 1.71, 95% CI = 1.25-2.35). At 6 weeks, this effect was only significant among women who reported (OR = 3.23, 95% CI = 1.24-8.40) versus did not report any previous density discussions (OR = 1.64, 95% CI = 0.83-3.26). A quarter of women in each arm never had a density conversation at any time during the study. Conclusions: Despite providing personalized density and risk information, the intervention did not promote density discussions between women and their providers who had not had them previously. This intervention is unlikely to be used clinically to motivate density conversations in women who have not had them before. Clinical trial registration number NCT03029286.

Keywords: breast cancer risk; breast density; communication; randomized trial; web-based.

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Conflict of interest statement

No competing financial interests exist.

Figures

FIG. 1.
FIG. 1.
CONSORT diagram for the ENGAGED-2 study showing the number of women invited for participation, then randomized to intervention and control, eligible and ineligible and reasons for nonparticipation, and finally, number participating in each baseline, 6-week, and 12-month survey. The primary 12-month clinical outcomes for this study were MRI and chemoprevention uptake. CONSORT, Consolidated Standards of Reporting Trials; MRI, magnetic resonance imaging.
FIG. 2.
FIG. 2.
This figure shows the number of study participants who discussed their breast density with a health care provider at each time point. Numbers are shown separately for intervention and control arms. The total numbers for each time point by study arm (6 weeks and 12 months) do not match the numbers in Table 2 because Figure 2 required women to answer the survey at each time point. Table 2 included women who answered a survey at any time point (e.g., at 12 months, but not at 6 weeks). C, control; I, intervention.

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