Clinical trial · Interventional
Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer
Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control arm | Other | — | UNRESOLVED |
| Experimental arm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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.
- interventionNames
- Behavioral: Experimental arm
- type
- OTHER
- label
- Control arm
- description
- 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).
- interventionNames
- Other: Control arm
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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