search
Back to results

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

Primary Purpose

Upper Aerodigestive Tract Neoplasms, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
integrated addiction treatment program
standard of care
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Aerodigestive Tract Neoplasms focused on measuring alcohol and tobacco consumption, addiction treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oscar Lambret Center
  • CHRU of Lille : Albert Calmette Hospital
  • CHRU of Lille: Huriez Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm A

Arm B

Arm Description

integrated addiction treatment program

standard of care

Outcomes

Primary Outcome Measures

Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
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

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.
Percentage of tobacco abstinent patients at 12 months
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.
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
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.
Median progression-free time
delay between inclusion date and progression date (clinical or radiological)
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

Full Information

First Posted
September 1, 2015
Last Updated
July 22, 2019
Sponsor
Centre Oscar Lambret
Collaborators
Centre Régional de Référence en Cancérologie, National Cancer Institute, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02540174
Brief Title
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment
Acronym
ALTAKRA-1405
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Centre Régional de Référence en Cancérologie, National Cancer Institute, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Aerodigestive Tract Neoplasms, Lung Cancer
Keywords
alcohol and tobacco consumption, addiction treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
integrated addiction treatment program
Arm Title
Arm B
Arm Type
Other
Arm Description
standard of care
Intervention Type
Procedure
Intervention Name(s)
integrated addiction treatment program
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
standard of care
Intervention Description
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 Measure Information:
Title
Difference in the rates of tobacco abstinent patients at 12 months between arms A and B
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of alcohol and tobacco consumptions during the study
Description
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.
Time Frame
initial diagnosis, after 3, 6 and 12 months
Title
Percentage of tobacco abstinent patients at 12 months
Description
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.
Time Frame
1 year
Title
Difference in the rates of alcohol and tobacco abstinent patients at 12 months depending on whether or not they have received an addiction treatment
Description
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
Time Frame
1 year
Title
Median time between inclusion date and the date of death (from any cause)
Description
Time until progression. The time between the date of inclusion and the date of death whatever the cause is.
Time Frame
1 year
Title
Median progression-free time
Description
delay between inclusion date and progression date (clinical or radiological)
Time Frame
1 year
Title
Percentage of Arm A patients who attended the addiction treatment program after the first systematic consultation
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Vannimenus, MD
Organizational Affiliation
CHRU of Lille
Official's Role
Study Director
Facility Information:
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
CHRU of Lille : Albert Calmette Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU of Lille: Huriez Hospital
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment

We'll reach out to this number within 24 hrs