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NCT Number: NCT06995417

Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study

The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.

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Key information

Conditions

Cancer of Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Careggi

Florence, Firenze, 51134, Italy

Location contact

LORENZO LIVI

CONTACT

[email protected]

+390557947019

Pierluigi Bonomo, MEDICAL DOCTOR

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with SCCHN tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses.
Patients older than 18 years of age with SCCHN of these sites who are candidates for surgical/radiotherapy (RT)/radiochemotherapy (RTCT) treatment with curative intent (primary treatment).
Patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer

Exclusion criteria

Patients with SCCHN cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process.
Patients using only e-cigarettes at the time of initiation of the treatment process.
Patients with non-SCCHN cancer in recurrent metastatic stage and not eligible for curative purpose therapy.

Treatment and study plan

Smoking counseling

Other

The investigator, upon enrollment, will initiate a standardized strategy from clinical practice: the investigator will conduct brief counseling ("minimal advice") using the administration of of a questionnaire that will include, in addition to questions about current and past, the administration of the Fagerstrom test to measure physical dependence on nicotine and questions to investigate intention to quit smoking (Mondor test)

Primary outcomes

Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation

Time frame: 6+1 months from enrollment, i.e., initiation of anti-smoking counseling.

The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.

Study contacts

Contact information is provided by the study sponsor or research team.

LUCIA PAOLINI

CONTACT

[email protected]

+393393830695

PIERLUIGI PB BONOMO, MEDICAL DOCTOR

CONTACT

[email protected]

+390557947010

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Acronym: STOP-HNC

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2030
First posted: May 29, 2025
Registry last updated: May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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