Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer

NCT03788785 | Completed

• 1 other identifier: K160704J
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma, Squamous Cell of Head and Neck; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  Proportion of patients with continuous abstinence during the last 6 months of the study, defined as having negative cotinine urine test at the last three visits.

  at 12 months after randomization

Secondary Outcomes (29)

• Reduction of Tobacco consumption

  12 months

• Reduction of Nicotine dependance

  12 months

• Proportion of patients with at least one visit with negative cotinine urine test

  12 months

• Tolerance of cancer treatments

  at 2 months

• Tolerance of cancer treatments

  at 4 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

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.

Behavioral: Experimental arm

Control arm

OTHER

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).

Other: Control arm

Interventions

Experimental arm BEHAVIORAL

The specific tobacco cessation intervention will be based on meeting with trained nurses : three 1/2 hour session of assessment of current addictive behaviors and motivation to change smoking habits occurring within five days tops.

Also known as: Specific tobacco cessation intervention

Experimental arm

Control arm OTHER

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).

Also known as: Standard tobacco cessation intervention

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient's refusal to participate
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Lariboisiere hospital

Paris, 75010, France

Location

Bichat hospital

Paris, France

Location

Tenon hospital

Paris, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 28, 2018
• Study Start: March 9, 2019
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

FR (3)