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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06995417
Acronym
STOP-HNC
Enrollment
200
Registered
2025-05-29
Start date
2025-06-30
Completion date
2030-05-31
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Head and Neck

Keywords

Cancer Head&Neck, Smoker

Brief summary

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.

Interventions

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)

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation6+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.

Countries

Italy

Contacts

Primary ContactPIERLUIGI PB BONOMO, MEDICAL DOCTOR
bonomopierlu@gmail.com+390557947010
Backup ContactLUCIA PAOLINI
rt.datamanager@sbsc.unifi.it+393393830695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026