Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer (NCT03788785) | Clinical Trial Compass
CompletedNot Applicable
Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer
France24 participantsStarted 2019-03-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Patient's refusal to participate
✕. Life expectancy \<6 months defined by multidisciplinary staff
✕. Lack health insurance (French social security)
✕. 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