Integrated Primary and Secondary Prevention of Smoking Related Diseases With Low Dose CT Scan and Circulating Biomarkers, Coupled With Personalised Smoking Cessation Activity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Create an innovative smoking cessation program with personalized and tailored primary prevention support within screening programs.
研究概览
简要总结
This is a prospective, observational, monocentric study. This study wants to test if among a smoking cessation intervention, behavioural counselling by video session is related to higher compliance and higher success rate than standard smoking cessation activity (face to face counselling).
详细描述
This intervention was structured on Sitab guidelines (Società Italiana Tabaccologia - Italian Tobacco Society), who suggest to use long-term counseling for at least six months and preferably for 12, in order to strengthen abstinence and cover the period with the highest risk of relapse. Clinicians who follow these guidelines must provide a path greater than or equal to 4 meetings and they will have a greater degree of success if the time that will be devoted to meetings is consistent. The group that will carry out the psychological counselling in the presence will have 6 meetings (spread over 6 months) with a psychologist at the anti-smoking center of the San Raffaele Hospital and a final phone call 12 months after the first meeting to verify the maintenance of abstinence. The meetings at the anti-smoking center are aimed at monitoring the progress of the smoking cessation process, thanks also to tests (fagestrom test, motivational questionnaire, smoker's diary) and prevent any drop outs. The group that will be followed in remote mode will carry out the same number of interviews as the group described above and a 12-months call will also be made to them to check the state of abstinence. The difference between the two groups is in the way interviews were conducted.
Both face-to-face interviews and those through videocall allow smokers, in addition to learning strategies to limit the consumption of the substance, to share the path towards de-exhaustion with a professional and be supported by it.
The subdivision into the two groups will be carried out through voluntary choice of participants.
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Strong smokers (pack years >= 20)
- •Over or equal the age of 50
- •Able to sign specific informed consent for the study
排除标准
- •Not having plans to quit smoking
结局指标
主要结局
Create an innovative smoking cessation program with personalized and tailored primary prevention support within screening programs.
时间窗: from enrollment to the end treatment at 1 year
The study aims to evaluate the difference in success between standard anti-smoking psychological counselling, conducted through face-to-face interviews, and anti-smoking psychological counselling conducted through remote video interviews.
次要结局
未报告次要终点
研究者
Pierluigi Novellis
Medical Doctor
Scientific Institute San Raffaele
