Carcinoma, Squamous Cell of Head and Neck, Tobacco Use Disorder
Conditions
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.
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.
Interventions
BEHAVIORALExperimental 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.
OTHERControl 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).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking abstinence | at 12 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Tobacco consumption | 12 months | Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline |
| Reduction of Nicotine dependance | 12 months | 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. |
| Proportion of patients with at least one visit with negative cotinine urine test | 12 months | — |
| Tolerance of cancer treatments | at 2 months | Proportion of reduction of adverse events reported |
| Satisfaction evaluated on a custom questionnaire | at 12 months | Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire. |
| Psychological state | at 12 months | 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). |
| Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale | at 2 months | 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'. |
| Pain assessed by pain-killer consumption | at 2 months | Decreased cumulated pain-killer consumption at each visit (morphine-equivalent) |
| Treatment response | at 2 months | — |
Countries
France
Outcome results
None listed