RANDOMIZED TRIAL OF BREAST SELF EXAMINATION IN SHANGHAI

这项提案要求在五年内继续资助一项随机的 乳房自我检查(BSE)试验目前正在520家工厂进行 上海市纺织工业局局长(中国)。这项研究的目的 就是确定常规的疯牛病治疗是否会降低死亡率 死于乳腺癌。近30万在职和退休女工 在30岁到之间被工厂随机分配到一个 干预组或对照组。正在收集基线访谈数据 来自所有研究参与者，干预组中的女性是 在当前期间接受初步的BSE指导和增援 资助期。在新的、密集的、反复的指导下 疯牛病将继续存在，并为实践疯牛病提供额外的动力 在定期的基础上是正确的。此外，遵守以下要求 实践BSE和在BSE绩效中的能力将持续 被监视着。所有女性将被跟踪10年，从最初的纳入 在乳腺癌的发生和乳腺癌死亡率的研究中 癌症和所有其他原因使用多种主动和被动报告 系统。初步跟进程序已在以下期间实施 当前资助期；将在#年期间实施其他程序 更新。这项研究具有大约80%的能力来检测 乳腺癌死亡率降低约30%。中期分析将 在本拟议授权期的第五年(平均 随访六年，180万妇女年)，试验将是 如果乳腺癌显著减少，那么在那个时候终止 观察死亡率；否则，将进行最终续签申请 已提交。这项试验是在几乎最理想的条件下进行的 到目前为止的条件和经验表明，成功完成 这项研究极有可能。结果将提供对 可合理预期的有益效果的上限 在大多数情况下，BSE，因此将提供所需的信息 估计疯牛病在降低死亡率方面的潜在影响 在美国罹患乳腺癌。

This proposal requests continued funding for five years for a randomized trial of breast self examination (BSE), currently underway in 520 factories of the Shanghai Textile Industry Bureau (China). The purpose of the study is to determine whether the regular practice of BSE will reduce mortality from breast cancer. Nearly 300,000 current and retired female workers between the ages of 30 and 64 have been randomly allocated by factory to an intervention or control group. Baseline interview data are being collected from all study participants, and women in the intervention group are receiving initial BSE instruction and reinforcement during the current funding period. Under the renewal, intensive and repeated instruction in BSE will be continued, and additional motivation provided to practice BSE correctly on a regular basis. In addition, compliance with requests to practice BSE and competency in BSE performance will be continuously monitored. All women will be followed for 10 years from initial inclusion in the study for the occurrence of breast cancer and mortality from breast cancer and all other causes using multiple active and passive reporting systems. Initial follow-up procedures have been implemented during the current funding period; additional procedures will be implemented during the renewal. This study has a power of approximately 80% to detect a reduction in breast cancer mortality of about 30%. Interim analyses will be performed during the fifth year of this proposed grant period (mean follow-up of six years, 1.8 million women-years), and the trial will be terminated at that time if a significant reduction in breast cancer mortality is observed; otherwise, a final continuation application will be submitted. This trial is being conducted under virtually optimal conditions and experience to date suggests that successful completion of the study is highly likely. The results will provide an estimate of the upper limit of the beneficial effects that can reasonably be expected of BSE in most situations, and will therefore provide information needed to estimate the potential impact that BSE could have in reducing mortality from breast cancer in the United States.