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Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment (ALTAKRA-1405)

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ClinicalTrials.gov Identifier: NCT02540174
Recruitment Status : Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Centre Régional de Référence en Cancérologie
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Upper Aerodigestive Tract Neoplasms Lung Cancer Procedure: integrated addiction treatment program Procedure: standard of care Not Applicable

Detailed Description:
  • Study proposal at the first medical consultation for therapeutic management of a first upper aerodigestive tract cancer or lung cancer.
  • Selection criteria validation
  • Collection of an informed consent
  • Randomization :

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of Integrating the Addiction Treatment to the Initial Cancer Treatment Program
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : December 18, 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A
integrated addiction treatment program
Procedure: integrated addiction treatment program

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.


Arm B
standard of care
Procedure: standard of care

The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology :

  • At the inclusion, a 45 minutes 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 (ppm) using the CO tester.
  • At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption




Primary Outcome Measures :
  1. Difference in the rates of tobacco abstinent patients at 12 months between arms A and B [ Time Frame: 1 year ]

    to be a "tobacco abstinent" patient has to :

    • be a smoker at the inclusion (M0)
    • declare to be weaned at M6
    • not declare a consumption between M6 and M12
    • a CO rate less than 10 ppm measured with a CO test at M6 and M12

    We compare the two arms in term of tobacco abstinent patients rate.



Secondary Outcome Measures :
  1. Frequency of alcohol and tobacco consumptions during the study [ Time Frame: initial diagnosis, after 3, 6 and 12 months ]
    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.

  2. Percentage of tobacco abstinent patients at 12 months [ Time Frame: 1 year ]

    to be a "tobacco abstinent" patient has to :

    • be a smoker at the inclusion (M0)
    • declare to be weaned at M6
    • not declare a consumption between M6 and M12
    • a CO rate less than 10 ppm measured with a CO test at M6 and M12

    We calculate the percentage of tobacco abstinent patients at 12 months considering every patient in the trial.


  3. Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment [ Time Frame: 1 year ]
    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

  4. Median time between inclusion date and the date of death (from any cause) [ Time Frame: 1 year ]
    Time until progression. The time between the date of inclusion and the date of death whatever the cause is.

  5. Median progression-free time [ Time Frame: 1 year ]
    delay between inclusion date and progression date (clinical or radiological)

  6. Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a first upper aerodigestive tract cancer or a lung cancer
  • Initial cancer treatment
  • Aged ≥ 18 and ≤65 years
  • Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
  • Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
  • Performance status (ECOG/WHO) ≤ 2
  • Registered with a social security system
  • Informed and signed consent collected before initiation of any study procedures

Exclusion Criteria:

  • Previous lung cancer or upper aerodigestive tract cancer
  • Previous other cancer < 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
  • Mesothelioma and esophageal cancer
  • Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
  • Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
  • Impossibility to comply with the study procedures due to geographic, social or mental reasons
  • Patient under guardianship or tutorship
  • Pregnant or breastfeeding women

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): NCT02540174


Locations
France
Oscar Lambret Center
Lille, France, 59020
CHRU of Lille : Albert Calmette Hospital
Lille, France, 59037
CHRU of Lille: Huriez Hospital
Lille, France, 59037
Sponsors and Collaborators
Centre Oscar Lambret
Centre Régional de Référence en Cancérologie
National Cancer Institute, France
Investigators
Study Director: Corinne Vannimenus, MD CHRU of Lille

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02540174     History of Changes
Other Study ID Numbers: ALTAKRA-1405
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
alcohol and tobacco consumption
addiction treatment

Additional relevant MeSH terms:
Lung Neoplasms
Behavior, Addictive
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Compulsive Behavior
Impulsive Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs