Clinical trial NCT02540174: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment
Official title: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of Integrating the Addiction Treatment to the Initial Cancer Treatment Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Aerodigestive Tract Neoplasms
Lung Cancer
Keywords: alcohol and tobacco consumption
addiction treatment
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Centre Régional de Référence en Cancérologie
name: National Cancer Institute, France
First posted: 2015-09-03
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of alcohol and tobacco consumptions during the study
timeFrame: initial diagnosis, after 3, 6 and 12 months
measure: Percentage of tobacco abstinent patients at 12 months
timeFrame: 1 year
measure: Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment
timeFrame: 1 year
measure: Median time between inclusion date and the date of death (from any cause)
timeFrame: 1 year
measure: Median progression-free time
timeFrame: 1 year
measure: Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation
timeFrame: 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
city: Lille
country: France
facility: CHRU of Lille : Albert Calmette Hospital
city: Lille
country: France
facility: CHRU of Lille: Huriez Hospital
Study officials:
affiliation: CHRU of Lille
name: Corinne Vannimenus, MD
role: STUDY_DIRECTOR
References: