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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 3
- 主要终点
- Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
研究概览
简要总结
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)
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A
integrated addiction treatment program
干预措施: integrated addiction treatment program (Procedure)
Arm B
standard of care
干预措施: standard of care (Procedure)
结局指标
主要结局
Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
时间窗: 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.
次要结局
- Percentage of tobacco abstinent patients at 12 months(1 year)
- Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation(1 year)
- Frequency of alcohol and tobacco consumptions during the study(initial diagnosis, after 3, 6 and 12 months)
- 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)