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
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
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 July 23, 2014