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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Abstinence at 1 month and 6 months after the end of treatment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Cigarette dependence (Cigarette Dependence Scale, CDS)(Baseline)
- Alcohol use and dependence (Alcohol Use Disorders Identification Test, AUDIT)(Baseline)
- Proportion of patients willing to attend a smoking cessation consultation(At the 1-month telephone follow-up after the end of treatment.)
- Abstinence at 1 month after the end of treatment(1 month after the end of treatment)
- Abstinence at 6 months after the end of treatment(6 months after the end of treatment)
- Abstinence at 12 months after the end of treatment(12 months after the end of treatment)