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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01578-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Centre Régional de Référence en Cancérologie | OTHER |
| National Cancer Institute, France | OTHER_GOV |
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This is a multicenter, interventional, randomized study among patients with a first lung or head & neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)
Arm A: Experimental arm : Addiction consultation to the overall cancer treatment
Arm B: standard of care
The completion of questionnaires , the measurement of exhaled carbone monoxide rate using a CO tester for all patients, and the integrated addiction treatment among patients randomized in Arm A will not interfere with the medical treatment of cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | integrated addiction treatment program |
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| Arm B | Other | standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated addiction treatment program | Procedure | At the inclusion, a 45 min interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I), the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million using the CO tester. At 3, 6, and 12 months : a 20 min interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption. The first addiction consultation will be carried out directly in the cancer treatment unit and integrated to the overall cancer treatment program. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the rates of tobacco abstinent patients at 12 months between arms A and B | to be a "tobacco abstinent" patient has to :
We compare the two arms in term of tobacco abstinent patients rate. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of alcohol and tobacco consumptions during the study | We considere the tobacco and alcohol consumption levels at T0, M3, M6, M12 by the consumption statement and the behaviour change towards tobacco and alcohol, thanks to questionnaires study specific. | initial diagnosis, after 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne Vannimenus, MD | CHRU of Lille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oscar Lambret Center | Lille | 59020 | France | |||
| CHRU of Lille : Albert Calmette Hospital |
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| standard of care | Procedure | The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology :
|
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| Percentage of tobacco abstinent patients at 12 months |
to be a "tobacco abstinent" patient has to :
We calculate the percentage of tobacco abstinent patients at 12 months considering every patient in the trial. |
| 1 year |
| Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment | We use a specialized monitoring in addictology (tobacco/alcohol) at 12 months according to the arms. The information of a monitoring in addictology will be obtained by the study specific questionnaire at M3, M6, M12 | 1 year |
| Median time between inclusion date and the date of death (from any cause) | Time until progression. The time between the date of inclusion and the date of death whatever the cause is. | 1 year |
| Median progression-free time | delay between inclusion date and progression date (clinical or radiological) | 1 year |
| Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation | We note for each patient in arm A if they have at least one addictology specialized consultation after the first consultation which is imposed, during the 12 months | 1 year |
| Lille |
| 59037 |
| France |
| CHRU of Lille: Huriez Hospital | Lille | 59037 | France |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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