Prevention of Smoking Related Diseases

Lung Cancer Clinical Trial

— LSP-3  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451029
• Other study ID #: 136/INT/2021
• Status: Recruiting
• Start date: January 11, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Scientific Institute San Raffaele
• Contact: Pierluigi Novellis, Medical Doctor
• Phone: +39 022643
• Email: novellis.pierluigi[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Strong smokers (pack years > 20)
• Over > the age of 50
• Able to sign specific informed consent for the study

Exclusion Criteria:

• Not having plans to quit smoking

Related Conditions & MeSH terms

• Lung Cancer
• Lung Cancer Screening
• Lung Neoplasms
• Smoking Cessation

Locations

Country	Name	City	State
Italy	Scientific Institute Ospedale San Raffaele	Milan	Italy, Milan

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create an innovative smoking cessation program with personalized and tailored primary prevention support within screening programs.	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.	from enrollment to the end treatment at 1 year