Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer

Lung Cancer Clinical Trial

— ALTAK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647425
• Other study ID #: ALTAK - 1109
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: January 23, 2018
• Start date: April 2012
• Est. completion date: September 2014

Study information

• Verified date: August 2014
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• physician assessment
Socio-economic conditions and general features: educational level, professional status... Assessment of current and past use of tobacco: current smoking status reported by the patient; in lifelong non-smokers: previous history of passive smoking reported by the patient; breath carbon monoxide level; in past smokers: age of first cigarette, total reported duration of active smoking, breath carbon monoxide level... in current smokers: age of first tobacco use, total reported duration of active smoking; Fagerström Nicotine Dependence Test... Assessment of the current and past uses of alcohol: previous-year assessment using the CAGE questionnaire and the AUDIT Test; average weekly alcohol consumption over the last 12 months... Assessment of current use of cannabis using the Cannabis Abuse Screening Test Psychiatric assessment using the MINI 5.0

Locations

Country	Name	City	State
France	Centre Hospitalier Régional et Universitaire - Hopital CALMETTE	Lille
France	Centre Hospitalier Régional et Universitaire - Hopital HURIEZ	Lille
France	Oscar Lambret Center	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Centre Régional de Référence en Cancérologie, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tobacco consumption	reported tobacco smoking	at 12 months
Secondary	tobacco smoking	frequency tobacco consumption	at baseline, 3 and 6 months
Secondary	alcohol drinking	frequency of alcohol consumption	at baseline, 3, 6 and 12 months
Secondary	progression free survival	median time between date of inclusion and date of first progression	at 12 months
Secondary	overall survival	median time between date of inclusion and date of death	at 12 months
Secondary	sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics		at baseline