Reducing Tobacco Related Health Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 639
- 试验地点
- 2
- 主要终点
- Number of Patients with Tobacco Abstinence
研究概览
简要总结
The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.
详细描述
Researchers want to learn if telephone counseling can help smokers change their smoking patterns, when combined with other interventions.
Study Groups:
During the first (baseline) visit, you will be randomly assigned (as in a throw of the dice) to 1 of 4 study groups. The first group will receive free self-help materials, and a referral to the Quitline. The Quitline provides free quit smoking services to eligible callers. The second group will receive free self-help materials, a referral to the Quitline, and 300 pieces of nicotine gum at baseline. The third group will receive free self-help materials, a referral to the Quitline, and 4 telephone counseling sessions over the next month. The fourth group will receive free self-help materials, a referral to the Quitline, 4 telephone counseling sessions over the next month, and 300 pieces of nicotine gum at baseline.
Study Visits:
If you choose to take part in this study, you will visit MD Anderson twice. Your first visit is the "baseline" visit when you enter the study and your final visit is the "follow-up" visit, which is 1 month after baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HCHD Patient or is at or below 200% of the poverty guideline
- •18 years of age or older
- •Current smoker
- •History of at least one cigarette per day for the past year
- •Not ready to quit in the next 30 days
- •Valid home address
- •Functioning telephone number
- •Can speak, read, and understand English
- •Register "5" or more on a carbon monoxide breath test
排除标准
- •Other household members enrolled in this study
- •Enrolled in any other smoking study during the past 90 days
- •Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
- •Regular use of tobacco products other than cigarettes
- •Pregnancy or lactation
- •Active substance dependence (exclusive of nicotine dependence)
- •Use of bupropion or nicotine products
结局指标
主要结局
Number of Patients with Tobacco Abstinence
时间窗: 24 months
Prolonged abstinence refers to abstinence beginning with initiation of the intervention and including a grace period. Prolonged abstinence measure utilizes the Society for Research on Nicotine and Tobacco's recommendation for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). Abstinence at all follow-ups will be biochemically verified using a carbon monoxide level of \<10ppm. Saliva samples collected for cotinine tests at the baseline and 24 month follow-up visits. Saliva samples analyzed for cotinine, a metabolic byproduct of nicotine that provides an estimate of nicotine consumption. A saliva cotinine level of \<20 ng/ml considered as abstinent.
次要结局
未报告次要终点