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NCT Number: NCT06910566

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemoradiotherapy or radiotherapy alone

Procedure

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.

Other names: chemoradiotherapy, radiotherapy

Primary outcomes

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

    Time frame: 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 outcomes

  1. Proportion of patients willing to attend a smoking cessation consultation

    Time frame: 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).

  2. Abstinence at 1 month after the end of treatment

    Time frame: 1 month after the end of treatment

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

  3. Abstinence at 6 months after the end of treatment

    Time frame: 6 months after the end of treatment

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

  4. Abstinence at 12 months after the end of treatment

    Time frame: 12 months after the end of treatment

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

  5. Cigarette dependence (Cigarette Dependence Scale, CDS)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: TABAC STOP ORL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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