Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment

NCT02540174 | Completed

• 2 other identifiers: ALTAKRA-14052014-A01578-39
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)

Conditions

Upper Aerodigestive Tract Neoplasms; Lung Cancer

Keywords

alcohol and tobacco consumption; addiction treatment

Outcome Measures

Primary Outcomes (1)

• Difference in the rates of tobacco abstinent patients at 12 months between arms A and B

  to be a "tobacco abstinent" patient has to : * be a smoker at the inclusion (M0) * declare to be weaned at M6 * not declare a consumption between M6 and M12 * a CO rate less than 10 ppm measured with a CO test at M6 and M12 We compare the two arms in term of tobacco abstinent patients rate.

  1 year

Secondary Outcomes (6)

• Frequency of alcohol and tobacco consumptions during the study

  initial diagnosis, after 3, 6 and 12 months

• Percentage of tobacco abstinent patients at 12 months

  1 year

• Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment

  1 year

• Median time between inclusion date and the date of death (from any cause)

  1 year

• Median progression-free time

  1 year

Study Arms (2)

Arm A

EXPERIMENTAL

integrated addiction treatment program

Procedure: integrated addiction treatment program

Arm B

OTHER

standard of care

Procedure: standard of care

Interventions

integrated addiction treatment program PROCEDURE

At the inclusion, a 45 min interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I), the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million using the CO tester. At 3, 6, and 12 months : a 20 min interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption. The first addiction consultation will be carried out directly in the cancer treatment unit and integrated to the overall cancer treatment program.

Arm A

standard of care PROCEDURE

The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology : * At the inclusion, a 45 minutes interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I) , the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million (ppm) using the CO tester. * At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption

Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a first upper aerodigestive tract cancer or a lung cancer
• Initial cancer treatment
• Aged ≥ 18 and ≤65 years
• Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
• Performance status (ECOG/WHO) ≤ 2
• Registered with a social security system
• Informed and signed consent collected before initiation of any study procedures

You may not qualify if:

• Previous lung cancer or upper aerodigestive tract cancer
• Mesothelioma and esophageal cancer
• Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
• Impossibility to comply with the study procedures due to geographic, social or mental reasons
• Patient under guardianship or tutorship
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Centre Régional de Référence en Cancérologie: collaborator
• National Cancer Institute, France: collaborator

Study Sites (3)

Oscar Lambret Center

Lille, 59020, France

Location

CHRU of Lille : Albert Calmette Hospital

Lille, 59037, France

Location

CHRU of Lille: Huriez Hospital

Lille, 59037, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Tobacco Use

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Corinne Vannimenus, MD

  CHRU of Lille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: May 27, 2015
• Primary Completion: November 9, 2016
• Study Completion: December 12, 2017
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)