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

NCT ID: NCT06910566

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Chemoradiotherapy or radiotherapy alone

Patients included in the study receive standard treatment with chemoradiotherapy or radiotherapy alone for their head and neck cancer or lung cancer. These treatments are part of their routine care and are not part of the observational study.

Intervention Type: PROCEDURE

Other Intervention Names

chemoradiotherapy; radiotherapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gautier LEFEBVRE, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fanny BEN OUNE

Role: CONTACT

promotion@o-lambret.fr

+33320295896

Facility Contacts

Gautier LEFEBVRE, MD

Role: primary

g-lefebvre@o-lambret.fr

+33320295896

Other Identifiers

2020-A02912-37

Identifier Type: OTHER

Identifier Source: secondary_id

TABAC STOP ORL POUMON-20-001

Identifier Type: -

Identifier Source: org_study_id