Lung or Head and Neck CancerSMALLHANNCT05523583
Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer
An observational study of Lung or Head and Neck Cancer, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head \& neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung or Head and Neck Cancer
- What is being tested?
- questionnaire
- How many people
- 165 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Oct 2022to 18 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: .): Patients treated in HCL, newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis
Who may be able to join
- Patients newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34)
- Patients who undergo front-line treatment
- Age 18 years or older
- Benefiting from a Social Security scheme
- Written information about the study provided to the patient before any procedure specific to the study
- Patients who had at least one episode of smoking within the past 30 days before diagnosis
Who cannot join
- History of another lung or head \& neck cancer < 5 years (Note: The presence of a second tumour location, discovered at the same time as the lung or head and neck cancer, does not constitute a non-inclusion criterion)
- History of another cancer (except for curatively treated cervical cancer in situ and non-melanoma skin cancer) < 3 years
- Mesothelioma, thymic malignancies, and cancer of the upper oesophagus
- Inability to complete the study for psychosocial reasons (inability to schedule interview (homeless), no access to phone, psychological disorder leading to inability to answer phone interview, do not speak French and no easy access to translator from surroundings)
- Patient under guardianship
- Patient refusal
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Louis Pradel, Pneumologie
Bron, 69317
Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale
Lyon, 69004
Hôpital de la Croix-Rousse, Pneumologie
Lyon, 69004
Hôpital Lyon Sud, Pneumologie
Pierre-Bénite, 69310
About this study
The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head \& neck cancer.
To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head \& neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head \& neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).
- Conditions
- Lung or Head and Neck Cancer
- Being tested
- questionnaire
- Keywords
- lung cancer, head and neck cancer, tabacco, alcohol
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Also called Tabacco and alcohol questionnaires
A trained interviewer (Clinical Research Associate : CRA) will administer a questionnaire soon after the diagnosis on the phone (within 15 calendar days after diagnosis). The participants are followed up during the first year following the diagnosis through 3 follow-up assessments (at 3, 6, and 12 months after the baseline assessment) and hospital record reviews. At each follow-up, a brief questionnaire will be administered by an interviewer (CRA) via telephone.
| Study group | Role | What they receive |
|---|---|---|
| Patients newly diagnosed with lung cancer or head & neck cancer | Patients newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of socio-professional determinants obtained by questionnaire
specific questionnaires querying demographics, socio-professional status, cessation or reduction attempts, and motivation and barriers to cessation, psychiatric conditions including level of addiction and depression.
Measured: Baseline
Description of accessibility-related determinants obtained by questionnaire
specific questionnaire querying travel time, distance, means of transportation used to access the hospital or cessation services
Measured: Baseline
Change of odds ratios and corresponding 95% confidence intervals for non-use of cessation services evaluated by questionnaire(0=non-use of service, 1=use of service)
Measured: Baseline and 3, 6 and 12 months
Change of odds ratios and corresponding 95% confidence intervals for continuation or relapse of tobacco use or dual use of tobacco and alcohol evaluated by questionnaire (0=abstinent, 1=continuation or relapse)
Measured: Baseline and 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start27 Oct 2022
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung or Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523583
- Sponsor's protocol ID
- 69HCL22_0090
- Acronym
- SMALLHAN
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05523583
- Acronym / sponsor ID
- SMALLHAN / 69HCL22_0090
- Conditions
- Lung or Head and Neck Cancer
- Keywords
- lung cancer, head and neck cancer, tabacco, alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- International Agency for Research on Cancer
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 31 Aug 2022 (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 overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head \& neck cancer.
To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head \& neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head \& neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients newly diagnosed with lung cancer or head & neck cancer | – | Other: questionnairePatients newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- .): Patients treated in HCL, newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis
Key inclusion criteria (6 listed)
- Patients newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34)
- Patients who undergo front-line treatment
- Age 18 years or older
- Benefiting from a Social Security scheme
- Written information about the study provided to the patient before any procedure specific to the study
Key exclusion criteria (6 listed)
- History of another lung or head \& neck cancer < 5 years (Note: The presence of a second tumour location, discovered at the same time as the lung or head and neck cancer, does not constitute a non-inclusion criterion)
- History of another cancer (except for curatively treated cervical cancer in situ and non-melanoma skin cancer) < 3 years
- Mesothelioma, thymic malignancies, and cancer of the upper oesophagus
- Inability to complete the study for psychosocial reasons (inability to schedule interview (homeless), no access to phone, psychological disorder leading to inability to answer phone interview, do not speak French and no easy access to translator from surroundings)
- Patient under guardianship
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 |
|---|---|---|
| questionnaireAlso: Tabacco and alcohol questionnairesA trained interviewer (Clinical Research Associate : CRA) will administer a questionnaire soon after the diagnosis on the phone (within 15 calendar days after diagnosis). The participants are followed up during the first year following the diagnosis through 3 follow-up assessments (at 3, 6, and 12 months after the baseline assessment) and hospital record reviews. At each follow-up, a brief questionnaire will be administered by an interviewer (CRA) via telephone. | Other | Patients newly diagnosed with lung cancer or head & neck cancer |
Primary outcome
Description of socio-professional determinants obtained by questionnaire
Time frame: Baseline
specific questionnaires querying demographics, socio-professional status, cessation or reduction attempts, and motivation and barriers to cessation, psychiatric conditions including level of addiction and depression.
Description of accessibility-related determinants obtained by questionnaire
Time frame: Baseline
specific questionnaire querying travel time, distance, means of transportation used to access the hospital or cessation services
Change of odds ratios and corresponding 95% confidence intervals for non-use of cessation services evaluated by questionnaire(0=non-use of service, 1=use of service)
Time frame: Baseline and 3, 6 and 12 months
Change of odds ratios and corresponding 95% confidence intervals for continuation or relapse of tobacco use or dual use of tobacco and alcohol evaluated by questionnaire (0=abstinent, 1=continuation or relapse)
Time frame: Baseline and 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung or Head and Neck Cancer, run by Hospices Civils de Lyon at 4 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of socio-professional determinants obtained by questionnaire (time frame: Baseline). The study lists 4 primary outcomes in all. 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 1 Oct 2025.