Smoking CessationTABAC STOP ORLNCT06910566
Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy
An observational study of Smoking Cessation and Nicotine Addiction, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Nicotine Addiction, Nicotine Dependence
- What is being tested?
- Chemoradiotherapy or radiotherapy alone
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2022to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Smoking Cessation, Nicotine Addiction, Nicotine Dependence, Smoking, Head and Neck Neoplasms
- Being tested
- Chemoradiotherapy or radiotherapy alone
- Keywords
- Tobacco abstinence, Head and neck cancer, Smoking cessation, Nicotine dependence, Cancer treatment
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Smoking, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoradiotherapy or radiotherapy aloneProcedure or surgery
Also called chemoradiotherapy, radiotherapy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 and 6 months after the end of treatment.
Secondary outcomes (6)
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start28 Mar 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gautier LEFEBVRE, MD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910566
- Sponsor's protocol ID
- TABAC STOP ORL POUMON-20-001
- Other IDs
- 2020-A02912-37
- Acronym
- TABAC STOP ORL
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06910566
- Acronym / sponsor ID
- TABAC STOP ORL / TABAC STOP ORL POUMON-20-001
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Patient receiving palliative treatment
- Patient under guardianship or curatorship
- Protocol-defined exit : After the 12-month consultation
- Withdrawal of consent for data collection
- Death of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemoradiotherapy or radiotherapy aloneAlso: chemoradiotherapy, radiotherapyPatients 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. | Procedure or surgery | – |
Primary outcome
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.
6 secondary outcomes
Proportion of patients willing to attend a smoking cessation consultation
Time frame: At the 1-month telephone follow-up after the end of treatment.
Abstinence at 1 month after the end of treatment
Time frame: 1 month after the end of treatment
Abstinence at 6 months after the end of treatment
Time frame: 6 months after the end of treatment
Abstinence at 12 months after the end of treatment
Time frame: 12 months after the end of treatment
Cigarette dependence (Cigarette Dependence Scale, CDS)
Time frame: Baseline
Alcohol use and dependence (Alcohol Use Disorders Identification Test, AUDIT)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gautier LEFEBVRE, MD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Nicotine Addiction, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence at 1 month and 6 months after the end of treatment (time frame: 1 and 6 months after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.