<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03788785</url>
  </required_header>
  <id_info>
    <org_study_id>K160704J</org_study_id>
    <nct_id>NCT03788785</nct_id>
  </id_info>
  <brief_title>Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer</brief_title>
  <acronym>INTENT</acronym>
  <official_title>Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper&#xD;
      aero-digestive tract. They are the 6th most prevalent type of cancer worldwide. The risk&#xD;
      related to tobacco is particularly high in the case of HNSCC, as the prevalence of heavy&#xD;
      smoking for long periods is high in this population. The investigators' aim is to compare two&#xD;
      models: one is a specific model of tobacco cessation intervention designed for health care&#xD;
      teams treating patients with HNSCC; the other is the current standard of care for these&#xD;
      patients, namely referral to external care after general advice on tobacco cessation. The&#xD;
      investigators will evaluate the efficacy of this intervention 12 months after randomization.&#xD;
      This intervention will be implemented into otolaryngology (ENT) care by training ENT nurses&#xD;
      with a specific program for tobacco cessation delivered to patients diagnosed with HNSCC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper&#xD;
      aero-digestive tract. They are the 6th most prevalent type of cancer worldwide, with&#xD;
      approximately 600 000 new cases every year. The investigators hypothesize that a&#xD;
      specifically-designed tobacco cessation intervention initiated and driven by trained nurses&#xD;
      of the health care team, either in the otolaryngology (ENT) department or in the radiotherapy&#xD;
      department, is more efficient than a classic intervention based on the same pharmacological&#xD;
      support during the hospital stay (NRT) followed by an orientation in an external smoking&#xD;
      cessation center, while remaining feasible for both patients and caregivers.The health care&#xD;
      setting represents an ideal place to initiate cessation interventions with smokers who are&#xD;
      newly diagnosed with a malignancy. The investigators' aim is to compare two models: one is a&#xD;
      specific model of tobacco cessation intervention designed for health care teams treating&#xD;
      patients with HNSCC; the other is the current standard of care for these patients, namely&#xD;
      referral to external care after general advice on tobacco cessation. The investigators will&#xD;
      evaluate the efficacy of this intervention 12 months after randomization. This intervention&#xD;
      will be implemented into otolaryngology (ENT) care by training ENT nurses with a specific&#xD;
      program for tobacco cessation delivered to patients diagnosed with HNSCC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking abstinence</measure>
    <time_frame>at 12 months after randomization</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of Tobacco consumption</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Nicotine dependance</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with at least one visit with negative cotinine urine test</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 2 months</time_frame>
    <description>Proportion of reduction of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 4 months</time_frame>
    <description>Proportion of reduction of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 6 months</time_frame>
    <description>Proportion of reduction of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 8 months</time_frame>
    <description>Proportion of reduction of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 10 months</time_frame>
    <description>Proportion of reduction of advrese events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of cancer treatments</measure>
    <time_frame>at 12 months</time_frame>
    <description>Proportion of reduction of adverse events reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction evaluated on a custom questionnaire</measure>
    <time_frame>at 12 months</time_frame>
    <description>Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological state</measure>
    <time_frame>at 12 months</time_frame>
    <description>Decrease in Hospital Anxiety and Depression scale (HAD) mean scores over time.&#xD;
The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.&#xD;
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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 2 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 4 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 6 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 8 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 10 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale</measure>
    <time_frame>at 12 months</time_frame>
    <description>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.&#xD;
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'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 2 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 4 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 6 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 8 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 10 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by pain-killer consumption</measure>
    <time_frame>at 12 months</time_frame>
    <description>Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">178</enrollment>
  <condition>Carcinoma, Squamous Cell of Head and Neck</condition>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental arm</intervention_name>
    <description>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.</description>
    <arm_group_label>Experimental arm</arm_group_label>
    <other_name>Specific tobacco cessation intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control arm</intervention_name>
    <description>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).</description>
    <arm_group_label>Control arm</arm_group_label>
    <other_name>Standard tobacco cessation intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years or older&#xD;
&#xD;
          2. Patients diagnosed with HNSCC and oriented toward any combination of the following&#xD;
             treatment: surgery, radiotherapy within one of the study sites, chemotherapy&#xD;
&#xD;
          3. Who smoke &gt; 10 or more cigarettes/day during the 3 months before diagnosis&#xD;
&#xD;
          4. With no quit attempts in the previous 3 months&#xD;
&#xD;
          5. Negative pregnancy test for women of childbearing age&#xD;
&#xD;
          6. For men and women : Using effective contraceptive methods during treatment and within&#xD;
             3 months after the end of treatment for men with her partner of childbearing age&#xD;
&#xD;
          7. Having signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient's refusal to participate&#xD;
&#xD;
          2. Life expectancy &lt;6 months defined by multidisciplinary staff&#xD;
&#xD;
          3. Lack health insurance (French social security)&#xD;
&#xD;
          4. Current guardianship&#xD;
&#xD;
          5. Non French-speaking patient&#xD;
&#xD;
          6. Living outside catchment area (200 kM around North Paris)&#xD;
&#xD;
          7. Severe cognitive impairment or unstable medical condition (psychiatric or other) that&#xD;
             does not permit informed consent and/or continuation of the questionnaire&#xD;
&#xD;
          8. Pregnancy, breastfeeding or lack of appropriate contraception during study duration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Benjamin Verillaud</last_name>
    <phone>+33149958061</phone>
    <email>benjamin.verillaud@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sylvie Chevret, Pr</last_name>
    <phone>+33142499742</phone>
    <email>sylvie.chevret@paris7.jussieu.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lariboisiere hospital</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin VERILLAUD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03788785
org study id: K160704J
nct id: NCT03788785
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Smoking abstinence
time frame: at 12 months after randomization
description: 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.
measure: Reduction of Tobacco consumption
time frame: 12 months
description: Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline
measure: Reduction of Nicotine dependance
time frame: 12 months
description: 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.
measure: Proportion of patients with at least one visit with negative cotinine urine test
time frame: 12 months
measure: Tolerance of cancer treatments
time frame: at 2 months
description: Proportion of reduction of adverse events reported
measure: Tolerance of cancer treatments
time frame: at 4 months
description: Proportion of reduction of adverse events reported
measure: Tolerance of cancer treatments
time frame: at 6 months
description: Proportion of reduction of adverse events reported
measure: Tolerance of cancer treatments
time frame: at 8 months
description: Proportion of reduction of adverse events reported
measure: Tolerance of cancer treatments
time frame: at 10 months
description: Proportion of reduction of advrese events reported
measure: Tolerance of cancer treatments
time frame: at 12 months
description: Proportion of reduction of adverse events reported
measure: Satisfaction evaluated on a custom questionnaire
time frame: at 12 months
description: Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.
measure: Psychological state
time frame: at 12 months
description: 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).
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 2 months
description: 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'.
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 4 months
description: 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'.
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 6 months
description: 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'.
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 8 months
description: 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'.
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 10 months
description: 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'.
measure: Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
time frame: at 12 months
description: 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'.
measure: Pain assessed by pain-killer consumption
time frame: at 2 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Pain assessed by pain-killer consumption
time frame: at 4 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Pain assessed by pain-killer consumption
time frame: at 6 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Pain assessed by pain-killer consumption
time frame: at 8 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Pain assessed by pain-killer consumption
time frame: at 10 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Pain assessed by pain-killer consumption
time frame: at 12 months
description: Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
measure: Treatment response
time frame: at 2 months
measure: Treatment response
time frame: at 4 months
measure: Treatment response
time frame: at 6 months
measure: Treatment response
time frame: at 8 months
measure: Treatment response
time frame: at 10 months
measure: Treatment response
time frame: at 12 months
arm group label: Experimental arm
arm group type: Experimental
description: 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.
arm group label: Control arm
arm group type: Other
description: 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).
intervention type: Behavioral
intervention name: Experimental arm
description: 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.
arm group label: Experimental arm
other name: Specific tobacco cessation intervention
intervention type: Other
intervention name: Control arm
description: 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).
arm group label: Control arm
other name: Standard tobacco cessation intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Verillaud
phone: +33149958061
email: benjamin.verillaud@gmail.com
last name: Sylvie Chevret, Pr
phone: +33142499742
email: sylvie.chevret@paris7.jussieu.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Tobacco Use Disorder
sharing ipd: Undecided