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)
Institut National du Cancer (INCa)
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647425
First received: July 19, 2012
Last updated: March 6, 2014
Last verified: July 2012
  Purpose

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


Condition Intervention
Head and Neck Cancer
Lung Cancer
Behavioral: consult with nurse addiction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Tobacco and Alcohol Consumption in Patients With First Head and Neck Cancer or Lung Cancer

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • alcohol and tobacco consumption [ Time Frame: 12 months after diagnosis ] [ Designated as safety issue: No ]
    frequency of tobacco and alcohol consumption questionnaires Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut-down Annoyed Guilty Eye-opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I.


Secondary Outcome Measures:
  • change in alcohol and tobacco consumption [ Time Frame: baseline, 3 months, 6 months after diagnosis ] [ Designated as safety issue: No ]
    frequency of alcohol and tobacco consumption

  • prevalence of smoking abstinence [ Time Frame: 12 months after diagnosis ] [ Designated as safety issue: No ]
    percentage of abstinent patient

  • progression free survival [ Time Frame: 24 months after diagnosis ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of first progression

  • overall survival [ Time Frame: 24 months after diagnosis ] [ Designated as safety issue: No ]
    median time between date of inclusion and date of death


Estimated Enrollment: 750
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
head and neck or lung cancer
patient with a first head and neck cancer or first lung cancer
Behavioral: consult with nurse addiction
baseline then 3, 6 and 12 months after diagnosis consult

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 cancer
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647425

Locations
France
Oscar Lambret Center
Lille, France, 59020
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
Lille, France, 59 037
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
Lille, France, 59 037
Sponsors and Collaborators
Centre Oscar Lambret
Centre de Référence Régional en Cancérologie (C2RC)
Institut National du Cancer (INCa)
Investigators
Study Director: Corinne VANNIMENUS, MD Centre Hospitalier Régional et Universitaire
  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: March 6, 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
addictology

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

ClinicalTrials.gov processed this record on April 17, 2014