Quitting smoking after head and neck squamous cell carcinoma diagnosis: a prospective study protocol

Quitting smoking after a diagnosis of squamous cell carcinoma of the head and neck (SCCHN) is associated with improved survival. However, the evidence supporting the systematic adoption of standardised counselling interventions is drawn primarily from limited retrospective data. To address this information gap, this prospective, multicentre study will assess whether standardised counselling increases the percentage of patients with long-term smoking cessation. The study will enrol adult patients with SCCHN who are active smokers or who quit within 30 days before diagnosis. Participants will receive counselling and will then be referred to dedicated smoking cessation centres. Follow-up assessments will be performed at regular intervals over three years and detect smoking status, adherence to cancer treatment, treatment-related toxicity, disease progression, survival outcomes (overall survival, progression-free survival, and cancer-specific survival), and quality of life. The primary outcome is the percentage of participants achieving sustained smoking cessation at 6 ± 1 months after enrolment. Targeted enrolment is 200 patients in 16 Italian centres, with enrolment planned to start in June 2025. Each recruiter will undergo specific training to ensure consistent delivery of counselling. The study results may guide clinical guidelines towards the integration of effective smoking cessation strategies into routine oncology practice.