RANDOMIZED TRIAL OF BREAST SELF EXAMINATION IN SHANGHAI

上海地区乳房自检随机试验

• 批准号: 2092318
• 负责人: David D Thomas
• 金额: $ 93.02万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-05-18 至 1997-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2092318
• 关键词: China; breast neoplasm /cancer diagnosis; cancer information system; cancer prevention; cancer risk; human mortality; human subject; interview; longitudinal human study; mass screening; neoplasm /cancer education; neoplasm /cancer epidemiology; questionnaires; self care; self help

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.

该提案要求继续资助五年， 乳房自我检查（BSE）试验，目前正在520家工厂进行 中国上海纺织工业局。 研究的目的 是为了确定是否有规律地进行疯牛病治疗会降低死亡率， 从乳腺癌。 近30万名在职和退休女工 年龄在30岁到64岁之间的人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 所有研究参与者中，干预组中的女性 在当前期间接收初始BSE指令和加强 融资期。 在更新，密集和重复的指导下， 将继续进行BSE，并为实践BSE提供额外的动力 正确地定期。 此外，遵守要求， 实践BSE和BSE性能的能力将持续 监控。 所有女性将从最初入选开始随访10年 在研究乳腺癌的发生率和乳腺癌的死亡率时， 癌症和所有其他原因使用多种主动和被动报告 系统. 初步后续程序已在2004年12月21日至2005年12月31日期间执行。 当前供资期;将在本供资期内实施额外程序 更新。 这项研究有大约80%的能力来检测 乳腺癌死亡率降低约30%。 中期分析将 在本拟议补助期的第五年进行（平均 随访6年，180万女性年），试验将 如果乳腺癌的显著减少， 观察到死亡率;否则，将提交最终的延续申请。 提交的。 这项试验是在几乎最佳的 迄今为止的条件和经验表明， 这项研究的可能性很大。 结果将提供一个估计， 可以合理预期的有益效果的上限 BSE在大多数情况下，因此将提供所需的信息， 估计BSE在降低死亡率方面的潜在影响 乳腺癌的发病率。