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

NCT06995417 | Not Yet Recruiting

• 1 other identifier: STOP-HNC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Keywords

Cancer Head&Neck; Smoker

Outcome Measures

Primary Outcomes (1)

• 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.

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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Azienda Ospedaliera Careggi

Florence, Firenze, 51134, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• LORENZO LL LIVI, MEDICAL DOCTOR

  Aou Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIERLUIGI PB BONOMO, MEDICAL DOCTOR

CONTACT

+390557947010; bonomopierlu@gmail.com

LUCIA PAOLINI

CONTACT

+393393830695; rt.datamanager@sbsc.unifi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

IT (1)