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

A Prospective Study on the Factors Sustaining Tobacco Abstinence in Patients Treated With Radio-chemotherapy or Radiotherapy Alone for Head and Neck or Lung Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking; Smoking Cessation; Head and Neck Neoplasms; Nicotine Dependence; Nicotine Addiction
• Intervention / Treatment: Procedure: Chemoradiotherapy or radiotherapy alone

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with head and neck cancer (HNC) or lung cancer, who are undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy at the Centre Oscar Lambret in Lille, France. Participants are current or former smokers and are recruited during the last week of their radiotherapy treatment. The study aims to evaluate factors associated with maintaining tobacco abstinence in this specific patient population, focusing on their smoking cessation journey following cancer treatment

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 and 6 months after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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	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	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Study Director: Gautier LEFEBVRE, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer treatment; Smoking cessation; Head and neck cancer; Nicotine dependence; Tobacco abstinence
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Use Disorder; Head and Neck Neoplasms; Smoking; Smoking Cessation; Therapeutics; Drug Therapy; Combined Modality Therapy; Radiotherapy; Chemoradiotherapy
• Other Study ID Numbers: TABAC STOP ORL POUMON-20-001; 2020-A02912-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No