Centre Oscar Lambret
Lille, 59020, France
NCT Number: NCT06910566
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Lille, 59020, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with human papillomavirus (HPV) may also be included
Exclusion criteria
Study Exit Criteria :
Early exit :
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
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.
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).
Time frame: 1 month after the end of treatment
Proportion of tobacco-abstinent patients 1 month after the end of radiotherapy or chemoradiotherapy
Time frame: 6 months after the end of treatment
Proportion of tobacco-abstinent patients 6 months after the end of radiotherapy or chemoradiotherapy
Time frame: 12 months after the end of treatment
Proportion of tobacco-abstinent patients 12 months after the end of radiotherapy or chemoradiotherapy
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.
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.
Centre Oscar Lambret
Other
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
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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