Clinical trial NCT06910566: Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smoking Cessation
Nicotine Addiction
Nicotine Dependence
Smoking
Head and Neck Neoplasms
Keywords: Tobacco abstinence
Head and neck cancer
Smoking cessation
Nicotine dependence
Cancer treatment
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Abstinence at 1 month and 6 months after the end of treatment
timeFrame: 1 and 6 months after the end of treatment.
Secondary outcomes:
measure: Proportion of patients willing to attend a smoking cessation consultation
timeFrame: At the 1-month telephone follow-up after the end of treatment.
measure: Abstinence at 1 month after the end of treatment
timeFrame: 1 month after the end of treatment
measure: Abstinence at 6 months after the end of treatment
timeFrame: 6 months after the end of treatment
measure: Abstinence at 12 months after the end of treatment
timeFrame: 12 months after the end of treatment
measure: Cigarette dependence (Cigarette Dependence Scale, CDS)
timeFrame: Baseline
measure: Alcohol use and dependence (Alcohol Use Disorders Identification Test, AUDIT)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Gautier LEFEBVRE, MD
role: STUDY_DIRECTOR
References: