Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment
- Conditions
- Upper Aerodigestive Tract NeoplasmsLung Cancer
- Interventions
- Procedure: integrated addiction treatment programProcedure: standard of care
- Registration Number
- NCT02540174
- Lead Sponsor
- Centre Oscar Lambret
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A integrated addiction treatment program integrated addiction treatment program Arm B standard of care standard of care
- Primary Outcome Measures
Name Time Method Difference in the rates of tobacco abstinent patients at 12 months between arms A and B 1 year 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.
- Secondary Outcome Measures
Name Time Method Percentage of tobacco abstinent patients at 12 months 1 year 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.Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation 1 year We note for each patient in arm A if they have at least one addictology specialized consultation after the first consultation which is imposed, during the 12 months
Frequency of alcohol and tobacco consumptions during the study initial diagnosis, after 3, 6 and 12 months 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.
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 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
Median time between inclusion date and the date of death (from any cause) 1 year Time until progression. The time between the date of inclusion and the date of death whatever the cause is.
Median progression-free time 1 year delay between inclusion date and progression date (clinical or radiological)
Trial Locations
- Locations (3)
Oscar Lambret Center
🇫🇷Lille, France
CHRU of Lille: Huriez Hospital
🇫🇷Lille, France
CHRU of Lille : Albert Calmette Hospital
🇫🇷Lille, France