Carcinoma, Squamous Cell of Head and NeckINTENTNCT03788785
Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer
A study testing Experimental arm in people with Carcinoma, Squamous Cell of Head and Neck and Tobacco Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck, Tobacco Use Disorder
- What is being tested?
- Experimental arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Mar 2019to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Patients diagnosed with HNSCC and oriented toward any combination of the following treatment: surgery, radiotherapy within one of the study sites, chemotherapy
- Patient who smoked in the last 3 months
- Negative pregnancy test for women of childbearing age
- 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
- Having signed written informed consent
Who cannot join
- Patient's refusal to participate
- Life expectancy <6 months defined by multidisciplinary staff
- Lack health insurance (French social security)
- Current guardianship
- Non French-speaking patient
- Living outside catchment area (200 kM around North Paris)
- Severe cognitive impairment or unstable medical condition (psychiatric or other) that does not permit informed consent and/or continuation of the questionnaire
- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
Trial locations and contacts
3 sites in 1 country.
France3 sites
Lariboisiere hospital
Paris, 75010
Bichat hospital
Paris
Tenon hospital
Paris
About this study
Official title: 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.
Read the 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.
- Being tested
- Experimental arm, Control arm
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armBehavioural
Also called Specific tobacco cessation intervention
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.
Control armOther
Also called Standard tobacco cessation intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | 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. Receives: Behavioral: Experimental arm |
| Control arm | Other | 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). Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 months after randomization
Secondary outcomes (29)
Reduction of Tobacco consumption
Proportion of patients with a 50% reduction or more of tobacco consumption between endpoint and baseline
Measured: 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.
Measured: 12 months
Proportion of patients with at least one visit with negative cotinine urine test
Measured: 12 months
Tolerance of cancer treatments
Proportion of reduction of adverse events reported
Measured: at 2 months
Tolerance of cancer treatments
Proportion of reduction of adverse events reported
Measured: at 4 months
Tolerance of cancer treatments
Proportion of reduction of adverse events reported
Measured: at 6 months
Tolerance of cancer treatments
Proportion of reduction of adverse events reported
Measured: at 8 months
Tolerance of cancer treatments
Proportion of reduction of advrese events reported
Measured: at 10 months
Tolerance of cancer treatments
Proportion of reduction of adverse events reported
Measured: at 12 months
Satisfaction evaluated on a custom questionnaire
Good satisfaction, feasibility and transferability of the intervention felt reported nurses on a custom questionnaire.
Measured: 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).
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: at 12 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 2 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 4 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 6 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 8 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 10 months
Pain assessed by pain-killer consumption
Decreased cumulated pain-killer consumption at each visit (morphine-equivalent)
Measured: at 12 months
Treatment response
Measured: at 2 months
Treatment response
Measured: at 4 months
Treatment response
Measured: at 6 months
Treatment response
Measured: at 8 months
Treatment response
Measured: at 10 months
Treatment response
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start9 Mar 2019
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788785
- Sponsor's protocol ID
- K160704J
- Acronym
- INTENT
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2018
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT03788785
- Acronym / sponsor ID
- INTENT / K160704J
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open, controlled, randomized, parallel-group, two-arm, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: Experimental armThe 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. |
| Control arm | Other | Other: Control armIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Patients diagnosed with HNSCC and oriented toward any combination of the following treatment: surgery, radiotherapy within one of the study sites, chemotherapy
- Patient who smoked in the last 3 months
- Negative pregnancy test for women of childbearing age
- 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
Key exclusion criteria (8 listed)
- Patient's refusal to participate
- Life expectancy <6 months defined by multidisciplinary staff
- Lack health insurance (French social security)
- Current guardianship
- Non French-speaking patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental armAlso: Specific tobacco cessation interventionThe 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. | Behavioural | Experimental arm |
| Control armAlso: Standard tobacco cessation interventionIn 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 |
Primary outcome
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.
29 secondary outcomes
Reduction of Tobacco consumption
Time frame: 12 months
Reduction of Nicotine dependance
Time frame: 12 months
Proportion of patients with at least one visit with negative cotinine urine test
Time frame: 12 months
Tolerance of cancer treatments
Time frame: at 2 months
Tolerance of cancer treatments
Time frame: at 4 months
Tolerance of cancer treatments
Time frame: at 6 months
Tolerance of cancer treatments
Time frame: at 8 months
Tolerance of cancer treatments
Time frame: at 10 months
Tolerance of cancer treatments
Time frame: at 12 months
Satisfaction evaluated on a custom questionnaire
Time frame: at 12 months
Psychological state
Time frame: at 12 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 2 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 4 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 6 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 8 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 10 months
Quality of life evaluated using the Euro-Quality of life - 5 Dimensions (EQ5D) scale
Time frame: at 12 months
Pain assessed by pain-killer consumption
Time frame: at 2 months
Pain assessed by pain-killer consumption
Time frame: at 4 months
Pain assessed by pain-killer consumption
Time frame: at 6 months
Pain assessed by pain-killer consumption
Time frame: at 8 months
Pain assessed by pain-killer consumption
Time frame: at 10 months
Pain assessed by pain-killer consumption
Time frame: at 12 months
Treatment response
Time frame: at 2 months
Treatment response
Time frame: at 4 months
Treatment response
Time frame: at 6 months
Treatment response
Time frame: at 8 months
Treatment response
Time frame: at 10 months
Treatment response
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm in people with Carcinoma, Squamous Cell of Head and Neck and Tobacco Use Disorder, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence (time frame: at 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.