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Prevention of Smoking Related Diseases

NCT ID: NCT06451029

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-11

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Lung Cancer Screening Smoking Cessation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pierluigi Novellis

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Scientific Institute Ospedale San Raffaele

Milan, Italy, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pierluigi Novellis, Medical Doctor

Role: CONTACT

[email protected]
+39 022643 ext. 7202

Facility Contacts

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Pierluigi Novellis, Medical Doctor

Role: primary

[email protected]
+39 022643 ext. 7202

Other Identifiers

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136/INT/2021

Identifier Type: -

Identifier Source: org_study_id