Clinical trial NCT03788785: Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer
Official title: Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Squamous Cell of Head and Neck
Tobacco Use Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. Patients diagnosed with HNSCC and oriented toward any combination of the following treatment: surgery, radiotherapy within one of the study sites, chemotherapy
3. Patient who smoked in the last 3 months
4. Negative pregnancy test for women of childbearing age
5. 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
6. Having signed written informed consent

Exclusion Criteria:

1. Patient's refusal to participate
2. Life expectancy \<6 months defined by multidisciplinary staff
3. Lack health insurance (French social security)
4. Current guardianship
5. Non French-speaking patient
6. Living outside catchment area (200 kM around North Paris)
7. Severe cognitive impairment or unstable medical condition (psychiatric or other) that does not permit informed consent and/or continuation of the questionnaire
8. Pregnancy, breastfeeding or lack of appropriate contraception during study duration

Primary outcomes:
measure: Smoking abstinence
timeFrame: at 12 months after randomization
Secondary outcomes:
measure: Reduction of Tobacco consumption
timeFrame: 12 months
measure: Reduction of Nicotine dependance
timeFrame: 12 months
measure: Proportion of patients with at least one visit with negative cotinine urine test
timeFrame: 12 months
measure: Tolerance of cancer treatments
timeFrame: at 2 months
measure: Tolerance of cancer treatments
timeFrame: at 4 months
measure: Tolerance of cancer treatments
timeFrame: at 6 months
measure: Tolerance of cancer treatments
timeFrame: at 8 months
measure: Tolerance of cancer treatments
timeFrame: at 10 months
measure: Tolerance of cancer treatments
timeFrame: at 12 months
measure: Satisfaction evaluated on a custom questionnaire
timeFrame: at 12 months
measure: Psychological state
timeFrame: at 12 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 2 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 4 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 6 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 8 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 10 months
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
timeFrame: at 12 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 2 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 4 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 6 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 8 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 10 months
measure: Pain assessed by pain-killer consumption
timeFrame: at 12 months
measure: Treatment response
timeFrame: at 2 months
measure: Treatment response
timeFrame: at 4 months
measure: Treatment response
timeFrame: at 6 months
measure: Treatment response
timeFrame: at 8 months
measure: Treatment response
timeFrame: at 10 months
measure: Treatment response
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisiere hospital
city: Paris
country: France
facility: Bichat hospital
city: Paris
country: France
facility: Tenon hospital
Study officials:
References: