COMMUNITY CLINICAL TRIAL FOR HEAVY SMOKERS

吸烟、烟草和癌症项目(STCP)，癌症预防司 和控制(DCPC)，国家癌症研究所(NCI)正在建立 重度吸烟者的多中心社区合作临床试验 研究计划测试重度吸烟者的策略(吸烟25人或更多 每天抽一支)：(1)有效地获得长期的 停止；(2)在大规模基础上实施是可行的；和(3) 采用社区干预方法，通过主要 有能力影响吸烟的组织和社会机构 在大群人中的行为。这项试验将涉及八个社区 干预中心(CIC)，每个中心提供一对匹配的 社区，每对社区中的社区被随机分配到 间歇或控制条件。审判将在#年进行 三个阶段：第一阶段，为期12个月的规划和议定书制定阶段； 第二阶段，为期60个月的干预和评估阶段；第三阶段，a 18个月的分析阶段。在批准了定义的第一阶段之后 STCP、DCPC、NCI及其科学顾问委员会的协议， 第二阶段和第三阶段将启动。只有那些能够完全 执行第二阶段议定书将继续进入第二阶段和第三阶段。 这另外三个备用地点将仅包括在第一阶段 8个主要CIC中的一个丢失的技术保障 可能需要扩大试验范围的统计重新考虑 给8个以上的CIC。

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.