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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Use Disorder; Carcinoma, Squamous Cell of Head and Neck
• Intervention / Treatment: Behavioral: Experimental arm; Other: Control arm

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Verillaud; Phone Number: +33149958061; Email: benjamin.verillaud@gmail.com
• Study Contact Backup: Name: Sylvie Chevret, Pr; Phone Number: +33142499742; Email: sylvie.chevret@paris7.jussieu.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Lariboisière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; 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; 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 Names: Specific tobacco cessation intervention
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).	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).; Other Names: Standard tobacco cessation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response		at 6 months
Reduction of Tobacco consumption	Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline	12 months
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
Proportion of patients with at least one visit with negative cotinine urine test		12 months
Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 2 months
Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 4 months
Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 6 months
Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 8 months
Tolerance of cancer treatments	Proportion of reduction of advrese events reported	at 10 months
Tolerance of cancer treatments	Proportion of reduction of adverse events reported	at 12 months
Satisfaction evaluated on a custom questionnaire	Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.	at 12 months
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
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
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
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
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
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
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
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 2 months
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 4 months
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 6 months
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 8 months
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 10 months
Pain assessed by pain-killer consumption	Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)	at 12 months
Treatment response		at 2 months
Treatment response		at 4 months
Treatment response		at 8 months
Treatment response		at 10 months
Treatment response		at 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 26, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Tobacco Use Disorder; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: K160704J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No