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

Tobacco Use Disorder Clinical Trial

— INTENT  

Official title:

Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788785
• Other study ID #: K160704J
• Status: Recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: June 2022

Study information

• Verified date: November 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Benjamin Verillaud
• Phone: +33149958061
• Email: benjamin.verillaud[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Who smoke > 10 or more cigarettes/day during the 3 months before diagnosis

4. With no quit attempts in the previous 3 months

5. Negative pregnancy test for women of childbearing age

6. 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

7. 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Neoplasms
• Tobacco Use Disorder

Intervention

Behavioral:
• Experimental arm
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.

Other:
• Control arm
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).

Locations

Country	Name	City	State
France	Lariboisiere hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of Tobacco consumption	Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline	12 months
Secondary	Reduction of Nicotine dependance	Proportion of patients with a 50% reduction or more at the Heaviness of Smoking Index (HSI) score between endpoint and Baseline. The Heavy smoking index (HSI) is the combination of two items (each scored between 0 and 3). The score range from 0 to 6. The cut-off point is 4. A high HSI score defined by a score of 4 or higher indicated high nicotinine dependance.	12 months
Secondary	Proportion of patients with at least one visit with negative cotinine urine test		12 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 2 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 4 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 6 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 8 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of advrese events reported	at 10 months
Secondary	Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 12 months
Secondary	Satisfaction evaluated on a custom questionnaire	Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.	at 12 months
Secondary	Psychological state	Decrease in Hospital Anxiety and Depression scale (HAD) mean scores over time.; The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.; HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score = 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score = 11).	at 12 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 2 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 4 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 6 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 8 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 10 months
Secondary	Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale	The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.; The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.	at 12 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 2 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 4 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 6 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 8 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 10 months
Secondary	Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 12 months
Secondary	Treatment response		at 2 months
Secondary	Treatment response		at 4 months
Secondary	Treatment response		at 6 months
Secondary	Treatment response		at 8 months
Secondary	Treatment response		at 10 months
Secondary	Treatment response		at 12 months