RANDOMIZED TRIAL OF BREAST SELF EXAMINATION IN SHANGHAI

上海地区乳房自检随机试验

• 批准号: 3190255
• 负责人: David D Thomas
• 金额: $ 31.01万
• 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 1992-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3190255
• 关键词: China; breast neoplasm /cancer diagnosis; cancer information system; cancer prevention; cancer risk; human mortality; human subject; longitudinal human study; mass screening; neoplasm /cancer education; self care

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.

提出了一个为期四年的项目来开发和实施一个 随机试验，以确定是否定期实践的 乳房自我检查（BSE）将降低乳腺癌的死亡率 癌经过一年的规划， 30万名现任或前任上海女性员工 纺织工业局（STIB）30岁至64岁之间， 455家工厂将被随机分配到一个 干预组或对照组。 妇女将接受采访， 获得有关乳腺癌和乳腺癌风险因素的信息 筛选和自我检查经验。 那些在 干预组将接受有关疯牛病强化指导， 技术的结合。 一年后，该指令将 加强，并评估BSE的能力和合规性， 干预组的所有女性。 提醒练习BSE 将在此期间和之后进行。 第四 在研究的一年中，两组中的所有女性都将积极参与 跟踪乳腺癌的发展，并确定 生命状态;并将在每组中选择一个样本， 确定乳腺癌筛查水平（如有）， 控制组，以及遵守和能力的水平， 在干预组中进行疯牛病治疗。 所有数据将被发送到 西雅图进行处理、编辑、监控和分析。 期间 第四年，将提出申请，以资助后续行动 和监测的合规性和能力， 8年（从初始干预开始10年）。 这项研究有一个 检测乳房缩小的把握度约为80% 十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 在审判预定结束之前，或者如果估计的差异 两组之间的筛查水平福尔斯降至80%以下 随后的调查表明，这种情况不能 完善 STIB为此提供了几乎最佳的条件 试验和成功的可能性很大。 结果将提供一个 对有益效果上限的估计， 在大多数情况下，BSE的合理预期， 因此，提供所需的信息，以估计潜在的 BSE对降低癌症死亡率的影响 美国的 本研究可归类为4期 在特定人群中进行癌症控制研究。