Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Smoking abstinence
研究概览
简要总结
Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper aero-digestive tract. They are the 6th most prevalent type of cancer worldwide. The risk related to tobacco is particularly high in the case of HNSCC, as the prevalence of heavy smoking for long periods is high in this population. The investigators' aim is to compare two models: one is a specific model of tobacco cessation intervention designed for health care teams treating patients with HNSCC; the other is the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation. The investigators will evaluate the efficacy of this intervention 12 months after randomization. This intervention will be implemented into otolaryngology (ENT) care by training ENT nurses with a specific program for tobacco cessation delivered to patients diagnosed with HNSCC.
详细描述
Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper aero-digestive tract. They are the 6th most prevalent type of cancer worldwide, with approximately 600 000 new cases every year. The investigators hypothesize that a specifically-designed tobacco cessation intervention initiated and driven by trained nurses of the health care team, either in the otolaryngology (ENT) department or in the radiotherapy department, is more efficient than a classic intervention based on the same pharmacological support during the hospital stay (NRT) followed by an orientation in an external smoking cessation center, while remaining feasible for both patients and caregivers.The health care setting represents an ideal place to initiate cessation interventions with smokers who are newly diagnosed with a malignancy. The investigators' aim is to compare two models: one is a specific model of tobacco cessation intervention designed for health care teams treating patients with HNSCC; the other is the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation. The investigators will evaluate the efficacy of this intervention 12 months after randomization. This intervention will be implemented into otolaryngology (ENT) care by training ENT nurses with a specific program for tobacco cessation delivered to patients diagnosed with HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Patients diagnosed with HNSCC and oriented toward any combination of the following treatment: surgery, radiotherapy within one of the study sites, chemotherapy
- •Patient who smoked in the last 3 months
- •Negative pregnancy test for women of childbearing age
- •For men and women : Using effective contraceptive methods during treatment and within 3 months after the end of treatment for men with her partner of childbearing age
- •Having signed written informed consent
排除标准
- •Patient's refusal to participate
- •Life expectancy <6 months defined by multidisciplinary staff
- •Lack health insurance (French social security)
- •Current guardianship
- •Non French-speaking patient
- •Living outside catchment area (200 kM around North Paris)
- •Severe cognitive impairment or unstable medical condition (psychiatric or other) that does not permit informed consent and/or continuation of the questionnaire
- •Pregnancy, breastfeeding or lack of appropriate contraception during study duration
研究组 & 干预措施
Experimental arm
The specific tobacco cessation intervention of the treatment group will begin during the diagnostic phase of the HNSCC by three ½ hour session of assessment of current addictive behaviors and motivation to change smoking habits occurring within five days top. The most important point is that this intervention will be provided by trained nurses of the health care team within the ENT department, rather than in an external smoking cessation center.
干预措施: Experimental arm (Behavioral)
Control arm
In the control arm, patients will receive the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation (self-help tools).
干预措施: Control arm (Other)
结局指标
主要结局
Smoking abstinence
时间窗: at 12 months after randomization
Proportion of patients with continuous abstinence during the last 6 months of the study, defined as having negative cotinine urine test at the last three visits.
次要结局
- Pain assessed by pain-killer consumption(at 12 months)
- Reduction of Tobacco consumption(12 months)
- Tolerance of cancer treatments(at 12 months)
- Satisfaction evaluated on a custom questionnaire(at 12 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 12 months)
- Reduction of Nicotine dependance(12 months)
- Proportion of patients with at least one visit with negative cotinine urine test(12 months)
- Psychological state(at 12 months)
- Treatment response(at 12 months)
- Treatment response(at 2 months)
- Treatment response(at 4 months)
- Treatment response(at 6 months)
- Treatment response(at 10 months)
- Treatment response(at 8 months)
- Tolerance of cancer treatments(at 2 months)
- Tolerance of cancer treatments(at 4 months)
- Tolerance of cancer treatments(at 6 months)
- Tolerance of cancer treatments(at 8 months)
- Tolerance of cancer treatments(at 10 months)
- Pain assessed by pain-killer consumption(at 10 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 2 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 4 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 6 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 8 months)
- Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale(at 10 months)
- Pain assessed by pain-killer consumption(at 2 months)
- Pain assessed by pain-killer consumption(at 4 months)
- Pain assessed by pain-killer consumption(at 6 months)
- Pain assessed by pain-killer consumption(at 8 months)