Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
试验速览
- 阶段
- 不适用
- 入组人数
- 370
- 主要终点
- Participant At-risk drinking status
研究概览
简要总结
RATIONALE: A counseling program that motivates patients to stop smoking and drinking may reduce the risk of oral cancer. It is not yet known whether motivational stop smoking counseling or motivational stop-smoking and stop drinking counseling is more effective in helping patients stop smoking and drinking.
PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and drinking works in preventing oral cancer in smokers in Puerto Rico.
详细描述
OBJECTIVES:
- To evaluate the effects of a motivational and problem-solving smoking cessation (MAPS) and a motivational and problem solving approach on at-risk alcohol use and smoking cessation (MAPS+) among Puerto Rican at-risk drinkers/smokers who call the Puerto Rico Quitline (PRQ).
- To assess effects of MAPS and MAPS+ on treatment mechanisms and the role of those mechanisms in mediating these effects on at-risk drinking and smoking cessation.
- To evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
OUTLINE: Minimization randomization is applied using the following variables: age, gender, cigarettes/day, number of drinks/day, and depression (score on the Center of Epidemiologic Studies Depression Scale). Patients are randomized to 1 of 2 intervention arms.
- Arm I (MAPS): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS approach includes motivational interviewing and cognitive behavioral/problem-solving that focus on smoking cessation.
- Arm II (MAPS+): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS+ approach includes motivational interviewing and cognitive behavioral/problems solving that focus on smoking cessation and the reduction of at-risk alcohol use.
In both arms, patients receive counseling calls over 15-30 minutes the week before quit date (QD), on QD, 3-5 days after QD, 7-10 days after QD, 15-30 days after QD, 45-60 days after QD, and on day 90 after QD. Patients complete questionnaires for alcohol- and smoking-related measures, self efficacy, stress/negative affects/depression, social support, and physical activity at baseline and weeks 12, 26 and 52 after QD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participant At-risk drinking status
时间窗: 52 weeks
Smoking cessation
时间窗: 52 weeks
次要结局
未报告次要终点
