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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Centre de Référence Régional en Cancérologie (C2RC)
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647425
First received: July 19, 2012
Last updated: September 23, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Head and Neck Cancer
Lung Cancer
Behavioral: physician assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • tobacco consumption [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    reported tobacco smoking


Secondary Outcome Measures:
  • tobacco smoking [ Time Frame: at baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    frequency tobacco consumption

  • alcohol drinking [ Time Frame: at baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    frequency of alcohol consumption

  • progression free survival [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of first progression

  • overall survival [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of death

  • sociodemographic, cancer-related, tobacco-related, alcohol-related, and psychiatric characteristics [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
head and neck or lung cancer
patient with a first head and neck cancer or first lung cancer
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient with a first head and neck cancer or first lung cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647425

Locations
France
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
Lille, France, 59 037
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Lille, France, 59 037
Oscar Lambret Center
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Centre de Référence Régional en Cancérologie (C2RC)
National Cancer Institute, France
Investigators
Study Director: Corinne VANNIMENUS, MD Centre Hospitalier Régional et Universitaire LILLE
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647425     History of Changes
Other Study ID Numbers: ALTAK - 1109
Study First Received: July 19, 2012
Last Updated: September 23, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
head and neck cancer
lung cancer
tobacco use disorder
alcoholism

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014