Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Carcinoma, Squamous Cell of Head and Neck
  • Tobacco Use Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical studyMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03788785
Collaborators
Not Provided
Investigators
Not Provided