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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial focused on head and neck cancer patients who also smoke, and it has now completed, has my doctor seen the results — and do they show whether a structured smoking cessation program actually helped people in my situation stay smoke-free during or after cancer treatment?
2Given that tobacco use can affect how well head and neck cancer treatment works, how important does my doctor think it is for me to quit smoking now, and would a program like the one studied in this trial be something worth pursuing alongside my current treatment plan?
3This trial measured smoking abstinence as its main outcome — can my doctor explain what kinds of support or interventions were typically included in integrated cessation programs for head and neck cancer patients, and whether anything similar is available to me here?
4Since this trial is completed but I don't know if the results have changed standard practice yet, should I be asking my care team about any evidence-based smoking cessation resources that are specifically designed for people going through head and neck cancer treatment?
5Would quitting smoking now realistically affect my treatment outcomes or recovery, and is my doctor aware of any findings from completed trials like this one that might guide what kind of cessation support they'd recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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