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临床试验/NCT06451029
NCT06451029招募中不适用

Integrated Primary and Secondary Prevention of Smoking Related Diseases With Low Dose CT Scan and Circulating Biomarkers, Coupled With Personalised Smoking Cessation Activity

Scientific Institute San Raffaele1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2022年1月11日最近更新:
适应症

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

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

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierluigi Novellis

Medical Doctor

Scientific Institute San Raffaele

研究点 (1)

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