COMMUNITY CLINICAL TRIAL FOR HEAVY SMOKERS

针对重度吸烟者的社区临床试验

• 批准号: 3621083
• 负责人: K MICHAEL CUMMINGS
• 金额: $ 62万
• 依托单位: ROSWELL PARK CANCER INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-09-30 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3621083
• 关键词: cancer information system; cancer prevention; cancer risk; clinical trials; community health services; human subject; longitudinal human study; tobacco abuse prevention

The Smoking, Tobacco, and Cancer Program (STCP), Division Cancer Prevention and Control (DCPC), of the National Cancer Institute (NCI) is establishing the multi-cneter Community Clinical Trial for Heavy Smokers as cooperative research program to test strategies for heavy smokers (smoking 25 of more cigarettes per day) that: (1) are effective in obtaining long term cessation; (2) are practical to implement on a large scale basis; and (3) employ a community intervention approach, working through major organizations and social institutions capable of influencing smoking behavior in large groups of people. The trial will involve eight Community Intervention Centers, (CIC) each contributing a matched pair of communities, with communities within each pair randomized to either the interventnion or the control condition. The trial will be conducted in three pahses: Phase I, a 12-month planning and protocol development phase; Phase II, a 60-month intervention and evaluation phase; and Phase III, a 18-month analysis phase. Following the approval of the Phase I defined protocol by the STCP, DCPC, NCI, and its Board of Scientific counselors, Phases II and III will be initiated. Only those CIC who are able to fully implement the Phase II protocol will be continued into Phases II and III. These additional three alternate sites will be included in Phase I only as a technical safeguard against the loss of one of the 8 primary CICs on statistical reconsiderations that could require the expansion of the trial to more than 8 CICs.

吸烟，烟草和癌症计划（STCP），癌症预防部门 国家癌症研究所（NCI）的DCPC正在建立 多中心协作的重度吸烟者社区临床试验 一项针对重度吸烟者（吸烟超过25%）的研究计划， （1）有效地获得长期 （2）在大规模实施时切实可行;（3） 采用社区干预方法，通过主要的 能够影响吸烟的组织和社会机构 在大群体中的行为。 该试验将涉及8个社区 干预中心（CIC），每个中心提供一对匹配的 社区，每对中的社区随机分配到 干预或控制条件。 试验将在 三个阶段：第一阶段，为期12个月的规划和方案制定阶段; 第二阶段，为期60个月的干预和评价阶段;第三阶段，a 18-月分析阶段。 在第一阶段获得批准后， STCP、DCPC、NCI及其科学顾问委员会的协议， 第二和第三阶段将开始。 只有那些能够完全 第二阶段方案的实施将持续到第二阶段和第三阶段。 这三个额外的备用研究中心将仅包括在第一阶段， 一个技术保障，防止8个主要CIC中的一个丢失， 可能需要扩大试验的统计学重新考虑 超过8个CIC。