About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
The study population will be 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 examinations) that led to the cancer diagnosis
Trial design
Case-only
Prospective
Treatments tested in this trial
Smoking counseling
Other interventionThe 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)
Treatment groups
Trial outcomes
Primary outcomes
Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation
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.
Sponsors and contacts
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