Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy (TABAC STOP ORL)

Centre Oscar Lambret

Status: Enrolling

Conditions: Nicotine Dependence; Nicotine Addiction; Head and Neck Neoplasms; Smoking; Smoking Cessation

Treatments: Procedure: Chemoradiotherapy or radiotherapy alone

Study type: Observational

Funder types: Other

Identifiers

NCT06910566

2020-A02912-37 (Other Identifier)

TABAC STOP ORL POUMON-20-001

Details and patient eligibility

About

The TABAC STOP ORL POUMON study aims to evaluate the factors influencing long-term smoking cessation in patients with head and neck cancer (HNC) or lung cancer undergoing radiotherapy or chemoradiotherapy. This is a single-center observational study, following patients at 1, 6, and 12 months after treatment completion. The primary objective is to determine the proportion of abstinent patients at 6 months, while secondary objectives analyze factors influencing abstinence, smoking trajectories, and reasons for relapse. A total of 100 patients will be included to ensure robust statistical analysis.

Full description

The TABAC STOP ORL POUMON study is a prospective, single-center observational study aiming to understand factors influencing long-term smoking cessation in patients treated for head and neck or lung cancer. Tobacco is a leading cause of death and disease, particularly in areas like Hauts-de-France with high smoking rates.

Eligible patients, undergoing radiotherapy or chemoradiotherapy, are enrolled during the final week of treatment, completing questionnaires assessing nicotine dependence and alcohol use. Follow-ups are scheduled at 1, 6, and 12 months, through clinic visits or phone interviews.

The primary endpoint is the proportion of patients who remain smoke-free at 6 months. Secondary endpoints include factors influencing smoking cessation, reasons for relapse, and changes in nicotine and alcohol dependence. The study will enroll 100 patients, expecting 81 evaluable cases, with data quality ensured through regular checks and source verification.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Patient aged 18 years or older
• Diagnosed with head and neck cancer or lung cancer
• Undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy
• Current or former smoker
• Patient covered by a social security scheme
• Patient informed and having given consent for data collection

Patients with human papillomavirus (HPV) may also be included

Exclusion Criteria :

• Patient receiving palliative treatment
• Patient under guardianship or curatorship

Study Exit Criteria :

- Protocol-defined exit : After the 12-month consultation

Early exit :

• Withdrawal of consent for data collection
• Death of the patient