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临床试验/NCT00139516
NCT00139516已完成不适用

Chinese Community Smoking Cessation Project

University of California, San Francisco0 个研究点开始时间: 2001年9月最近更新:
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试验速览

阶段
不适用
状态
已完成

研究概览

简要总结

The study has two objectives/aims:

Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese adults with and without diseases); and

Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking process) that are associated with smoking cessation at 6 and 12 months

详细描述

BACKGROUND:

Studies of smoking cessation intervention among hospitalized patients with CVD and pulmonary disease produced varying cessation rates, ranging from 20 to 51% among patients with pulmonary disease, from 22 to 71% among survivors of coronary disease and as much as 80% among lung cancer patients (3-8). Recently published Treating Tobacco Use and Dependence Clinical Practice Guideline (1) provides detailed evaluation and synthesis of evidence-based components of effective smoking cessation interventions and summary results for selected treatment modalities are presented in Table 1. Face-to-face counsel, strong advice from physician or nurse, the number of reinforcing sessions and duration of these sessions were related to success (9). Compared to no treatment, estimated abstinence rates for treatment modalities ranged from 10.2% to 26.5%. Thus, use of combination treatment modalities in smoking cessation intervention is expected to result in higher abstinence rate.

The proposed four-year prospective, randomized clinical trial with 12 months follow-up, will test the efficacy of a culturally and linguistically tailored physician directed, nurse managed, smoking cessation and relapse prevention intervention among Chinese smokers. The study has two aims: 1) To test the efficacy of the intervention among smokers; and 2) To examine a set of measures (background, general health, psychosocial, and smoking process) that are associated with smoking cessation at 6 and 12 months. Subjects who smoked in the 3 months prior to admission at 6 San Francisco Bay Area hospitals (1 university, 4 private and 1 county) will be screened, recruited and randomized to one of two interventions: a) Intensive [n=190] (physician advice, bedside counseling with a family member, 5 telephone contacts within 90 days, with nicotine replacement therapy and one repeat relapse counseling with 1 more telephone contact for relapsers). b) Minimal [n=190] (physician advice and a self-help manual). Random assignment will be stratified by recruitment site, gender and disease category. Primary outcomes include biochemically confirmed abstinence and quit attempts at 6 and 12 months. Power calculation is based on 15% difference in abstinence rates between the two intervention groups. The findings from this propose study will yield significant knowledge for effectively treating Chinese smokers and will provide insight into treatment for smokers of other racial and ethnic minorities that is likely to have significant public health impact by reducing health disparities among US sub-populations.

DESIGN NARRATIVE:

A prospective, randomized clinical trial with 12-month follow-up linguistically tailored, nurse-managed smoking cessation and relapse prevention trial. It involves several stages in the study:

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Prevention

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having smoked a cigarette, cigar, or tobacco pipe during the 3 months preceding the baseline interview
  • reside in the San Francisco Bay Area at baseline
  • must be fluent in either English or Chinese (Mandarin or Cantonese)
  • be 18 and over in age and
  • not currently engaging in assisted smoking cessation efforts
  • Exclusion criteria
  • unable to speak English or Chinese
  • too ill to participate, or not willing to participate in smoking cessation effort
  • pregnancy
  • major psychiatric illness not under control/treatment

排除标准

  • 未提供

研究者

申办方类型
Other

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