Kaiser Permanente Washington Health Research Institute, Seattle, WA.
University of Washington, Seattle, WA.
Perm J. 2020 Dec;24:1-4. doi: 10.7812/TPP/19.205.
We evaluated demographic and clinical characteristics associated with participation in a clinical trial testing the efficacy of an online tool to support breast cancer risk communication and decision support for risk mitigation to determine the generalizability of trial results.
Eligible women were members of Kaiser Permanente Washington aged 40-69 years with a recent normal screening mammogram, heterogeneously or extremely dense breasts and a calculated risk of > 1.67% based on the Breast Cancer Surveillance Consortium 5-year breast cancer risk model. Trial outcomes were chemoprevention and breast magnetic resonance imaging by 12-months post-baseline. Women were recruited via mail with phone follow-up using plain language materials notifying them of their density status and higher than average breast cancer risk. Multivariable logistic regression calculated independent odds ratios (ORs) for associations between demographic and clinical characteristics with trial participation.
Of 2,569 eligible women contacted, 995 (38.7%) participated. Women with some college (OR = 1.99, 95% confidence interval [CI] 1.34-2.96) or college degree (OR = 3.35, 95% CI 2.29-4.90) were more likely to participate than high school-educated women. Race/ethnicity also was associated with participation (African-American OR = 0.50, 95% CI 0.29-0.87; Asian OR = 0.22, 95% CI 0.12-0.41). Multivariate adjusted ORs for family history of breast/ovarian cancer were not associated with trial participation.
Use of plain language and potential access to a website providing personal breast cancer risk information and education were insufficient in achieving representative participation in a breast cancer prevention trial. Additional methods of targeting and tailoring, potentially facilitated by clinical and community outreach, are needed to facilitate equitable engagement for all women.
我们评估了与参加一项临床试验的参与相关的人口统计学和临床特征，该试验测试了一种在线工具的功效，以支持乳腺癌风险沟通和降低风险的决策支持，以确定试验结果的普遍性。
符合条件的女性是 Kaiser Permanente Washington 的成员，年龄在 40-69 岁之间，最近的筛查乳房 X 光检查正常，乳房异质性或极度致密，并且根据乳腺癌监测联盟 5 年乳腺癌风险模型计算的风险> 1.67%。试验结果是基线后 12 个月的化学预防和乳腺磁共振成像。通过邮件招募女性，并通过使用通俗易懂的材料进行电话随访，通知她们的密度状况和高于平均水平的乳腺癌风险。多变量逻辑回归计算了人口统计学和临床特征与试验参与之间的独立优势比（OR）。
在接触的 2569 名合格女性中，有 995 名（38.7%）参与了试验。具有一些大学学历（OR=1.99，95%置信区间[CI]1.34-2.96）或大学学历（OR=3.35，95%CI 2.29-4.90）的女性比具有高中学历的女性更有可能参与。种族/民族也与参与有关（非裔美国人 OR=0.50，95%CI 0.29-0.87；亚洲人 OR=0.22，95%CI 0.12-0.41）。多变量调整后的乳腺癌/卵巢癌家族史的 OR 与试验参与无关。
使用通俗易懂的语言和潜在访问提供个人乳腺癌风险信息和教育的网站不足以实现乳腺癌预防试验的代表性参与。需要额外的靶向和定制方法，可能通过临床和社区外展来促进，以促进所有女性的公平参与。
