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

Centre Oscar Lambret133 enrolled

Overview

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)

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

133

Conditions

Upper Aerodigestive Tract Neoplasms Lung Cancer

Interventions

integrated addiction treatment programPROCEDURE

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.

standard of carePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Oscar Lambret Center

Lille, France

CHRU of Lille : Albert Calmette Hospital

Lille, France

CHRU of Lille: Huriez Hospital

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Frequency of alcohol and tobacco consumptions during the study

We considere the tobacco and alcohol consumption levels at T0, M3, M6, M12 by the consumption statement and the behaviour change towards tobacco and alcohol, thanks to questionnaires study specific.

Time frame: initial diagnosis, after 3, 6 and 12 months

Percentage of tobacco abstinent patients at 12 months

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 calculate the percentage of tobacco abstinent patients at 12 months considering every patient in the trial.

Time frame: 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

We use a specialized monitoring in addictology (tobacco/alcohol) at 12 months according to the arms. The information of a monitoring in addictology will be obtained by the study specific questionnaire at M3, M6, M12

Time frame: 1 year

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

Time until progression. The time between the date of inclusion and the date of death whatever the cause is.

Time frame: 1 year

Data from ClinicalTrials.gov

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