Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy

N/AActive Not RecruitingNCT06910566

Centre Oscar Lambret100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Smoking Cessation Nicotine Addiction Nicotine Dependence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Abstinence at 1 month and 6 months after the end of treatment

The primary outcome measure will be abstinence at 1 month (physical consultation or telephone follow-up) and at 6 months after the end of treatment.

Time frame: 1 and 6 months after the end of treatment.

Secondary Outcomes

Proportion of patients willing to attend a smoking cessation consultation

Evaluation of patients willing to attend a smoking cessation consultation (assessed among active smokers at the phone follow-up consultation).

Time frame: At the 1-month telephone follow-up after the end of treatment.

Abstinence at 1 month after the end of treatment

Proportion of tobacco-abstinent patients 1 month after the end of radiotherapy or chemoradiotherapy

Time frame: 1 month after the end of treatment

Abstinence at 6 months after the end of treatment

Proportion of tobacco-abstinent patients 6 months after the end of radiotherapy or chemoradiotherapy

Time frame: 6 months after the end of treatment

Abstinence at 12 months after the end of treatment

Proportion of tobacco-abstinent patients 12 months after the end of radiotherapy or chemoradiotherapy

Time frame: 12 months after the end of treatment

Cigarette dependence (Cigarette Dependence Scale, CDS)

Level of nicotine dependence assessed using the Cigarette Dependence Scale (CDS). The CDS is a validated 12-item scale with scores ranging from 0 to 60, where higher scores indicate dependence.

Time frame: Baseline

Alcohol use and dependence (Alcohol Use Disorders Identification Test, AUDIT)

Alcohol consumption and dependence assessed using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a 10-item scale with scores ranging from 0 to 40, where higher scores indicate higher risk of alcohol-related harm.