Clinical trial NCT01647425: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer
Official title: Prevalence and Risk Factors for Persistent Tobacco or Alcohol Use Over the First Year of a First Lung or Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lung Cancer
Keywords: head and neck cancer
lung cancer
tobacco use disorder
alcoholism
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Centre Régional de Référence en Cancérologie
name: National Cancer Institute, France
First posted: 2012-07-23
Enrollment: 385
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: patient with a first head and neck cancer or first lung cancer

Brief summary: This is an multicenter study for preventive and therapeutic strategies for patients with head and neck cancer

Detailed description: Continuing the chronic intoxication by either tobacco or alcohol after the initial diagnosis of a first lung or head and neck cancer significantly improves the risk of experiencing a second cancer, and largely affects the long term survival. Addiction intervention programs should be personalized according to the patient's profile, with the aim to develop more sustained intervention and monitoring in patients identified at higher risk of not spontaneously stopping harmful substance use. As of today, the trajectories of smoking and drinking habits and the risk factors for persisting smoking or drinking habits have been insufficiently explored among patients with a first lung or head and neck cancer.

The ALTAK study aims to depict the rate of tobacco smokers 12 months after the initial diagnosis of a first lung or head and neck cancer. The secondary objectives of the study are:

* to depict the rate of alcohol users 12 months after the initial diagnosis of a H\&N cancer
* to depict the rate of tobacco smokers at cancer diagnosis
* to depict the rate of alcohol users at cancer diagnosis
* to determine the social, motivational, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping tobacco in the year following the diagnosis of a first TARC.
* to determine the social, psychiatric, tobacco-related, alcohol-related, and cannabis-related features associated with stopping alcohol drinking in the year following the diagnosis of a first H\&N cancer

Eligibility criteria: Inclusion Criteria:

* first head and neck or lung cancer
* first support
* age ≥ 18
* patient covered by health insurance
* signed informed consent

Exclusion Criteria:

* prior lung or head and neck cancer
* History of another cancer \<5 years, not evolutive and untreated at baseline (carcinoma of the cervix, or basal cell carcinoma of the skin properly treated are allowed). The presence of a second discovery tumor location at the same time as the lung or head and neck cancer, is not a criteria for non-inclusion
* mesothelioma and oesophageal cancer
* unable to undergo trail medical follow up (geographical, social and psychological reasons)
* pregnant or nursing women
* patient under guardianship

Primary outcomes:
measure: tobacco consumption
timeFrame: at 12 months
Secondary outcomes:
measure: tobacco smoking
timeFrame: at baseline, 3 and 6 months
measure: alcohol drinking
timeFrame: at baseline, 3, 6 and 12 months
measure: progression free survival
timeFrame: at 12 months
measure: overall survival
timeFrame: at 12 months
measure: sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics
timeFrame: at baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
city: Lille
country: France
facility: Oscar Lambret Center
Study officials:
affiliation: Centre Hospitalier Régional et Universitaire LILLE
name: Corinne VANNIMENUS, MD
role: STUDY_DIRECTOR
References:
citation: Vannimenus C, Bricout H, Le Rouzic O, Mouawad F, Chevalier D, Dansin E, Rotsaert L, Lefebvre G, Cottencin O, Porte H, Scherpereel A, El Fahsi A, Richard F, Rolland B; ALTAK Study Group. Compared characteristics of current vs. past smokers at the time of diagnosis of a first-time lung or head and neck cancer: a cross-sectional study. BMC Cancer. 2018 Apr 3;18(1):372. doi: 10.1186/s12885-018-4253-5.