Prevention of Smoking Related Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Lung Cancer Screening, Smoking Cessation. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrated Primary and Secondary Prevention of Smoking Related Diseases With Low Dose CT Scan and Circulating Biomarkers, Coupled With Personalised Smoking Cessation Activity
Overview
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).
Detailed description
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.
Primary outcome measures
- Create an innovative smoking cessation program with personalized and tailored primary prevention support within screening programs. [Time frame: from enrollment to the end treatment at 1 year]
Eligibility criteria
Inclusion criteria
- Strong smokers (pack years >= 20)
- Over or equal the age of 50
- Able to sign specific informed consent for the study
Exclusion criteria
- Not having plans to quit smoking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Scientific Institute Ospedale San Raffaele — Milan
Identifiers
NCT: NCT06451029 · 136/INT/2021