ClinicalTrials.gg
RecruitingNCT06451029LSP-3Updated Nov 29, 2024

Prevention of Smoking Related Diseases

An observational study in Lung Cancer, Lung Cancer Screening and Smoking Cessation, sponsored by Scientific Institute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Scientific Institute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
189
Ages
50 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Lung Cancer Screening
  • Smoking Cessation

Keywords

  • lung cancer screening
  • smoking cessation
  • counseling
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 189 is close to the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Strong smokers enrolled in the lung cancer screening program.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not having plans to quit smoking
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
189 participants (estimated)
Patient registry
No

Groups and cohorts

  • face-to-face interviews

    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 in the hospital and a final phone call 12 months after the first meeting to verify the maintenance of abstinence.

  • video interviews

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from enrollment to the end treatment at 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06451029
Lead sponsor
Scientific Institute San Raffaele
Responsible party
Pierluigi Novellis (Medical Doctor, Scientific Institute San Raffaele) — Principal investigator
First posted
Jun 10, 2024
Start date
Jan 11, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Pierluigi Novellis, Medical Doctor
Contact
novellis.pierluigi@hsr.it
+39 022643 ext. 7202

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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