- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647425
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer (ALTAK)
Prevalence and Risk Factors for Persistent Tobacco or Alcohol Use Over the First Year of a First Lung or Head and Neck Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59020
- Oscar Lambret Center
-
Lille, France, 59 037
- Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
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Lille, France, 59 037
- Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
head and neck or lung cancer
patient with a first head and neck cancer or first lung cancer
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tobacco consumption
Time Frame: at 12 months
|
reported tobacco smoking
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at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tobacco smoking
Time Frame: at baseline, 3 and 6 months
|
frequency tobacco consumption
|
at baseline, 3 and 6 months
|
|
alcohol drinking
Time Frame: at baseline, 3, 6 and 12 months
|
frequency of alcohol consumption
|
at baseline, 3, 6 and 12 months
|
|
progression free survival
Time Frame: at 12 months
|
median time between date of inclusion and date of first progression
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at 12 months
|
|
overall survival
Time Frame: at 12 months
|
median time between date of inclusion and date of death
|
at 12 months
|
|
sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics
Time Frame: at baseline
|
at baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Corinne VANNIMENUS, MD, Centre Hospitalier Régional et Universitaire LILLE
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTAK - 1109
- 2011-A01659-32 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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