NCT06451029

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

May 30, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

lung cancer screeningsmoking cessationcounseling

Outcome Measures

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.

    from enrollment to the end treatment at 1 year

Study Arms (2)

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.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Strong smokers enrolled in the lung cancer screening program.

You may qualify if:

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

You may not qualify if:

  • Not having plans to quit smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute Ospedale San Raffaele

Milan, Italy, Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Central Study Contacts

Pierluigi Novellis, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 10, 2024

Study Start

January 11, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations