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

NCT ID: NCT02540174

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-27
• Study Completion Date: 2017-12-12

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)

Detailed Description

• Study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer.
• Selection criteria validation
• Collection of an informed consent
• Randomization :

Arm A: Experimental arm : Addiction consultation to the overall cancer treatment

Arm B: standard of care

The completion of questionnaires , the measurement of exhaled carbone monoxide rate using a CO tester for all patients, and the integrated addiction treatment among patients randomized in Arm A will not interfere with the medical treatment of cancer.

Conditions

Upper Aerodigestive Tract Neoplasms; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm A

integrated addiction treatment program

Group Type: EXPERIMENTAL

integrated addiction treatment program

Intervention Type: 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 B

standard of care

Group Type: OTHER

standard of care

Intervention Type: 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

Interventions

integrated addiction treatment program

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.

Intervention Type: PROCEDURE

standard of care

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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
• Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
• Performance status (ECOG/WHO) ≤ 2
• Registered with a social security system
• Informed and signed consent collected before initiation of any study procedures

Exclusion Criteria

• Previous lung cancer or upper aerodigestive tract cancer
• Previous other cancer < 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
• Mesothelioma and esophageal cancer
• Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
• Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
• Impossibility to comply with the study procedures due to geographic, social or mental reasons
• Patient under guardianship or tutorship
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Régional de Référence en Cancérologie

OTHER

Sponsor Role: collaborator

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne Vannimenus, MD

Role: STUDY_DIRECTOR

CHRU of Lille

Locations

Oscar Lambret Center

Lille, , France

CHRU of Lille : Albert Calmette Hospital

Lille, , France

CHRU of Lille: Huriez Hospital

Lille, , France

Countries

France

Other Identifiers

ALTAKRA-1405

Identifier Type: -

Identifier Source: org_study_id