Clinical trial NCT05523583: Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer
Official title: Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung or Head and Neck Cancer
Keywords: lung cancer
head and neck cancer
tabacco
alcohol
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: International Agency for Research on Cancer
First posted: 2022-08-31
Enrollment: 165
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: .): 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

Brief 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Description of socio-professional determinants obtained by questionnaire
timeFrame: Baseline
measure: Description of accessibility-related determinants obtained by questionnaire
timeFrame: Baseline
measure: 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)
timeFrame: Baseline and 3, 6 and 12 months
measure: 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)
timeFrame: Baseline and 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel, Pneumologie
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse, Pneumologie
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud, Pneumologie
Study officials:
References: