Dataset Information

Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.

ABSTRACT:

Background

Despite widespread implementation of mammographic breast density (MBD) notification laws, the impact of these laws on knowledge of MBD and knowledge of breast cancer risk is limited by the lack of tools to promote informed decision-making in practice.

Objective

To develop and evaluate whether brief, personalized informational videos following a normal mammogram in addition to a legislatively required letter about MBD result can improve knowledge of MBD and breast cancer risk compared to standard care (i.e., legislatively required letter about MBD included with the mammogram result).

Design/participants

Prospective randomized controlled trial of English-speaking women, age 40-74 years, without prior history of breast cancer, receiving a screening mammogram with a normal or benign finding (intervention group n = 235, control group n = 224).

Intervention

brief (3-5 min) video, personalized to a woman's MBD result and breast cancer risk.

Main measures

Primary outcomes were a woman's knowledge of her MBD and risk of breast cancer. Secondary outcomes included whether a woman reported that she discussed the results of her mammogram with her primary care provider (PCP).

Key results

Relative to women in the control arm, women in the intervention arm had greater improvement in their knowledge of both their personal MBD (intervention pre/post 39.2%/ 77.5%; control pre/post 36.2%/ 37.5%; odds ratio (OR) 5.34 for change for intervention vs. control, 95% confidence interval (CI) 3.87-7.36; p < 0.001) and risk of breast cancer (intervention pre/post: 66.8%/74.0%; control pre/post 67.9%/ 65.2%; OR 1.42, 95% confidence interval (CI) 1.09-1.84; p = 0.01). Women in the intervention group were more likely than those in the control group to report discussing the results of their mammogram with their PCP (p = 0.05).

Conclusions

Brief, personalized videos following mammography can improve knowledge of MBD and personal risk of breast cancer compared to a legislatively mandated informational letter. Trial Registration Clinicaltrials.gov (NCT02986360).

SUBMITTER: Haas JS

PROVIDER: S-EPMC6445917 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Publications

Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.

Haas Jennifer S JS Giess Catherine S CS Harris Kimberly A KA Ansolabehere Julia J Kaplan Celia P CP

Journal of general internal medicine 20180808 4

<h4>Background</h4>Despite widespread implementation of mammographic breast density (MBD) notification laws, the impact of these laws on knowledge of MBD and knowledge of breast cancer risk is limited by the lack of tools to promote informed decision-making in practice.<h4>Objective</h4>To develop and evaluate whether brief, personalized informational videos following a normal mammogram in addition to a legislatively required letter about MBD result can improve knowledge of MBD and breast cancer ...[more]

PMID: 30091121

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Project description:BackgroundDense breast notification (DBN) legislation aims to increase a woman's awareness of her personal breast density and the implications of having dense breasts for breast cancer detection and risk. This information may adversely affect women's breast cancer worry, perceptions of risk, and uncertainty about screening, which may persist over time or vary by sociodemographic factors. We examined short- and long-term psychological responses to DBN and awareness of breast density (BD).MethodsIn a predominantly Hispanic New York City screening cohort (63% Spanish-speaking), ages 40-60 years, we assessed breast cancer worry, perceived breast cancer risk, and uncertainties about breast cancer risk and screening choices, in short (1-3 months)- and long-term (9-18 months) surveys following the enrollment screening mammogram (between 2016 and 2018). We compared psychological responses by women's dense breast status (as a proxy for DBN receipt) and BD awareness and examined multiplicative interaction by education, health literacy, nativity, and preferred interview language.ResultsIn multivariable models using short-term surveys, BD awareness was associated with increased perceived risk (odds ratio (OR) 2.27, 95% confidence interval (CI) 0.99, 5.20 for high, OR 2.19, 95% CI 1.34, 3.58 for moderate, vs. low risk) in the overall sample, and with increased uncertainty about risk (OR 1.97 per 1-unit increase, 95% CI 1.15, 3.39) and uncertainty about screening choices (OR 1.73 per 1-unit increase, 95% CI 1.01, 2.9) in Spanish-speaking women. DBN was associated with decreased perceived risk among women with at least some college education (OR 0.32, 95% CI 0.11, 0.89, for high, OR 0.50, 95% CI 0.29, 0.89, for moderate vs. low risk), while those with a high school education or less experienced an increase (OR 3.01, 95% CI 1.05, 8.67 high vs. low risk). There were no associations observed between DBN or BD awareness and short-term breast cancer worry, nor with any psychological outcomes at long-term surveys.ConclusionsAssociations of BD awareness and notification with breast cancer-related psychological outcomes were limited to short-term increases in perceived breast cancer risk dependent on educational attainment, and increases in uncertainty around breast cancer risk and screening choices among Spanish-speaking women.

Project description:ImportanceWhether the benefits of notifying women about breast density outweigh the potential harms to inform current and future mammogram screening practice remains unknown.ObjectiveTo assess the effect of mammographic breast density notification and information provision on women's intention to seek supplemental screening and psychological outcomes.Design, setting, and participantsA 3-arm online randomized clinical trial was conducted from August 10 to 31, 2021. Data analysis was conducted from September 1 to October 20, 2021. Participants included Australian residents identifying as female, aged between 40 and 74 years, with no history of breast cancer who were residing in jurisdictions without existing breast density notification with screening mammograms.InterventionsWomen were randomized to receive 1 of the following hypothetical breast screening test result letters: screening mammogram result letter without breast density messaging (control), screening mammogram result letter with breast density messaging and an existing density information letter taken from a screening service in Australia (intervention 1), and screening mammogram result letter with breast density messaging and a health literacy-sensitive version of the letter adapted for people with lower health literacy (intervention 2).Main outcomes and measuresPrimary outcomes were intention to seek supplemental screening; feeling anxious (uneasy, worried, or nervous), informed, or confused; and having breast cancer worry.ResultsA total of 1420 Australian women were randomized and included in the final analysis. The largest group consisted of 603 women aged 60 to 74 years (42.5%). Compared with the control cohort (n = 480), women who received density notification via intervention 1 (n = 470) and intervention 2 (n = 470) reported a significantly higher intention to seek supplemental screening (0.8% vs 15.6% and 14.2%; P < .001) and feeling anxious (14.2% vs 49.4% and 48.5%; P < .001), confusion (7.8% vs 24.0% and 23.6%; P < .001), and worry about breast cancer (quite/very worried: 6.9% vs 17.2% and 15.5%; P < .001). There were no statistically significant differences in these outcomes between the 2 intervention groups.Conclusions and relevanceIn this randomized clinical trial, breast density notification and information integrated with screening mammogram results increased women's intention to seek supplemental screening and made women feel anxious, confused, or worried about breast cancer. These findings have relevance and implications for mammogram screening services and policy makers considering whether and, if so, how best to implement widespread notification of breast density as part of mammography screening.Trial registrationACTRN12621000253808.

Project description:BackgroundTwenty-eight states have passed breast density notification laws, which require physicians to inform women of a finding of dense breasts on mammography.ObjectiveTo evaluate changes in breast cancer stage at diagnosis after enactment of breast density notification legislation.DesignUsing a difference-in-differences analysis, we examined changes in stage at diagnosis among women with breast cancer in Connecticut, the first state to enact legislation, compared to changes among women in control states. We used data from the Surveillance, Epidemiology, and End Results Program (SEER) registry, 2005-2013.ParticipantsWomen ages 40-74 with breast cancer.InterventionBreast density notification legislation, enacted in Connecticut in October of 2009.Main measureBreast cancer stage at diagnosis.Key resultsOur study included 466,930 women, 25,592 of whom lived in Connecticut. Legislation was associated with a 1.38-percentage-point (95 % CI 0.12 to 2.63) increase in the proportion of women in Connecticut versus control states who had localized invasive cancer at the time of diagnosis, and a 1.12-percentage-point (95 % CI -2.21 to -0.08) decline in the proportion of women with ductal carcinoma in situ at diagnosis. Breast density notification legislation was not associated with a change in the proportion of women in Connecticut versus control states with regional-stage (-0.09 percentage points, 95 % CI -1.01 to 1.02) or metastatic disease (-0.24, 95 % CI -0.75 to 0.28). County-level analyses and analyses limited to women younger than 50 found no statistically significant associations.LimitationsSingle intervention state, limited follow-up, potential confounding from unobserved trends.ConclusionsBreast density notification legislation in Connecticut was associated with a small increase in the proportion of women diagnosed with localized invasive breast cancer in individual-level but not county-level analyses. Whether this finding reflects potentially beneficial early detection or potentially harmful overdiagnosis is not known. Legislation was not associated with changes in regional or metastatic disease.

Dataset Information

Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.

Background

Objective

Design/participants

Intervention

Main measures

Key results

Conclusions

Publications

Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.

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