RANDOMIZED TRIAL OF BREAST SELF EXAMINATION IN SHANGHAI

提出了一个为期四年的项目，以制定和实施 随机试验，以确定是否常规做法 乳房自我检查(BSE)将降低乳房死亡率 癌症。在为期一年的规划期之后，大约 300,000名现任或前任上海市女员工 年30岁至之间的纺织工业局 455家工厂将被随机分配给一家 干预组或对照组。女性将接受采访，以 获取有关乳腺癌和乳腺癌风险因素的信息 筛查和自我检查的经验。那些生活在 干预组将对BSE进行强化指导，使用 一种技术的结合。一年后，该指令将 得到加强，并对BSE的能力和合规性进行评估 干预组所有女性。练习疯牛病的注意事项 将在过渡期间提供，并在随后提供。在第四节期间 在学习之年，两组的所有女性都将积极 对乳腺癌的发展进行随访，并确定 生命状态；每组将选出一名样本 确定乳腺癌筛查水平(如果有的话) 控制组，以及合规性和能力级别 干预组实施BSE。所有数据都将发送到 西雅图用于处理、编辑、监控和分析。在.期间 第四年，将编写一份申请，以资助后续行动 以及监控其他客户的合规性和能力 八年(从最初干预算起十年)。这项研究有一个 检测乳房缩小的能力约为80% 10年内癌症死亡率约为30%。中期分析将 如果出现以下情况，试验将提前终止 乳腺癌死亡率显著降低。 在审判计划结束之前，或者如果估计的差异 两组之间的筛查水平降至80%以下 而随后的调查表明，情况不可能 要有所改进。STIB为此提供了几乎最优的条件 试验和成功的可能性很高。结果将提供一个 估计可能产生的有益影响的上限 在大多数情况下合理地符合疯牛病的预期，并将 因此提供所需的信息来估计潜在的 疯牛病在降低癌症死亡率方面可能产生的影响 美国。这项研究可以归类为第四阶段 在确定的人群中进行癌症控制研究。

A four-year project is proposed to develop and implement a randomized trial to determine whether the regular practice of breast self-examination (BSE) will reduce mortality from breast cancer. Following a one-year planning period, approximately 300,000 current or former female employees of the Shanghai Textile Industry Bureau (STIB) between the ages of 30 and 64 in 455 factories will be randomly allocated factory to an intervention or control group. Women will be interviewed to obtain information on risk factors for breast cancer and breast screening and self-examination experience. Those in the intervention group will be given intensive instruction in BSE using a combination of techniques. One year later, the instruction will be reinforced, and competency and compliance in BSE assessed in all women in the intervention group. Reminders to practice BSE will be given in the interim, and subsequently. During the fourth year of the study, all women in both groups will be actively followed up for development of breast cancer and to ascertain vital status; and a sample in each group will be selected to ascertain the level of screening for breast cancer (if any) in the control group, and the level of compliance and competency in practicing BSE in the intervention group. All data will be sent to Seattle for processing, editing, monitoring, and analysis. During the fourth year, an application will be written to fund follow-up and monitoring for compliance and competency for an additional eight years (10 years from initial intervention). This study has a power of approximately 80% to detect a reduction in breast cancer mortality of about 30% in 10 years. Interim analyses will be performed and the trial will be terminated early if either a significant reduction in breast cancer mortality is demonstrated before the trial is scheduled to end, or if the estimated difference in the level of screening between the two groups falls below 80% and subsequent investigation indicates that the situation cannot be improved. The STIB offers virtually optimal conditions for this trial and success is highly likely. The results will provide an estimate of the upper limits of the beneficial effect that can reasonably to 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 cancer in the United States. This study could be classified as Phase 4 cancer control research in a defined population.