Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer

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).

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Key information

Conditions

Lung or Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Pradel, Pneumologie, Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Questionnaire

Other

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.

Other names: Tabacco and alcohol questionnaires

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

International Agency for Research on Cancer

Registry information

Acronym: SMALLHAN

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Aug 31, 2022
Registry last updated: Oct 1, 2025

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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