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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788785
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell of Head and Neck Tobacco Use Disorder Behavioral: Experimental arm Other: Control arm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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 Name: Specific tobacco cessation intervention

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 Name: Standard tobacco cessation intervention




Primary Outcome Measures :
  1. Smoking abstinence [ Time Frame: 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 Outcome Measures :
  1. Reduction of Tobacco consumption [ Time Frame: 12 months ]
    Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline

  2. Reduction of Nicotine dependance [ Time Frame: 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.

  3. Proportion of patients with at least one visit with negative cotinine urine test [ Time Frame: 12 months ]
  4. Tolerance of cancer treatments [ Time Frame: at 2 months ]
    Proportion of reduction of adverse events reported

  5. Tolerance of cancer treatments [ Time Frame: at 4 months ]
    Proportion of reduction of adverse events reported

  6. Tolerance of cancer treatments [ Time Frame: at 6 months ]
    Proportion of reduction of adverse events reported

  7. Tolerance of cancer treatments [ Time Frame: at 8 months ]
    Proportion of reduction of adverse events reported

  8. Tolerance of cancer treatments [ Time Frame: at 10 months ]
    Proportion of reduction of advrese events reported

  9. Tolerance of cancer treatments [ Time Frame: at 12 months ]
    Proportion of reduction of adverse events reported

  10. Satisfaction evaluated on a custom questionnaire [ Time Frame: at 12 months ]
    Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.

  11. Psychological state [ Time Frame: 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).


  12. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: 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'.


  13. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: at 4 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'.


  14. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: at 6 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'.


  15. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: at 8 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'.


  16. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: at 10 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'.


  17. Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale [ Time Frame: at 12 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'.


  18. Pain assessed by pain-killer consumption [ Time Frame: at 2 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  19. Pain assessed by pain-killer consumption [ Time Frame: at 4 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  20. Pain assessed by pain-killer consumption [ Time Frame: at 6 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  21. Pain assessed by pain-killer consumption [ Time Frame: at 8 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  22. Pain assessed by pain-killer consumption [ Time Frame: at 10 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  23. Pain assessed by pain-killer consumption [ Time Frame: at 12 months ]
    Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)

  24. Treatment response [ Time Frame: at 2 months ]
  25. Treatment response [ Time Frame: at 4 months ]
  26. Treatment response [ Time Frame: at 6 months ]
  27. Treatment response [ Time Frame: at 8 months ]
  28. Treatment response [ Time Frame: at 10 months ]
  29. Treatment response [ Time Frame: at 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788785


Contacts
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Contact: Benjamin Verillaud +33149958061 benjamin.verillaud@gmail.com
Contact: Sylvie Chevret, Pr +33142499742 sylvie.chevret@paris7.jussieu.fr

Locations
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France
Lariboisiere hospital Recruiting
Paris, France, 75010
Contact: Benjamin VERILLAUD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03788785    
Other Study ID Numbers: K160704J
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Tobacco Use Disorder
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell