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

Recruiting

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

• Registration Number: NCT06910566
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abstinence at 1 month and 6 months after the end of treatment	1 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.

Secondary Outcome Measures

Name	Time	Method
Cigarette dependence (Cigarette Dependence Scale, CDS)	Baseline	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.
Alcohol use and dependence (Alcohol Use Disorders Identification Test, AUDIT)	Baseline	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.
Proportion of patients willing to attend a smoking cessation consultation	At the 1-month telephone follow-up after the end of treatment.	Evaluation of patients willing to attend a smoking cessation consultation (assessed among active smokers at the phone follow-up consultation).
Abstinence at 1 month after the end of treatment	1 month after the end of treatment	Proportion of tobacco-abstinent patients 1 month after the end of radiotherapy or chemoradiotherapy
Abstinence at 6 months after the end of treatment	6 months after the end of treatment	Proportion of tobacco-abstinent patients 6 months after the end of radiotherapy or chemoradiotherapy
Abstinence at 12 months after the end of treatment	12 months after the end of treatment	Proportion of tobacco-abstinent patients 12 months after the end of radiotherapy or chemoradiotherapy

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France