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

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

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)

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Upper Aerodigestive Tract Neoplasms
• Intervention / Treatment: Procedure: integrated addiction treatment program; Procedure: standard of care

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
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Oscar Lambret Center
  • Lille, France, 59037
    • CHRU of Lille : Albert Calmette Hospital
  • Lille, France, 59037
    • CHRU of Lille: Huriez Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 : 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.	1 year

Secondary Outcome Measures

Outcome Measure	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
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.	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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France; Centre Régional de Référence en Cancérologie
• Investigators: Study Director: Corinne Vannimenus, MD, CHRU of Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2015
• Primary Completion (Actual): November 9, 2016
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: addiction treatment; alcohol and tobacco consumption
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Compulsive Behavior; Impulsive Behavior; Head and Neck Neoplasms; Lung Neoplasms; Behavior, Addictive
• Other Study ID Numbers: ALTAKRA-1405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO