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Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

Primary Purpose

Head and Neck Cancer, Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Addiction support
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring addiction support, addiction specialist, lung cancer, head and neck cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first head and neck or lung cancer
  • first support
  • 18 ≤ age ≤ 60
  • lives in Lille Metropolis
  • having an addiction to alcohol and tobacco
  • covered by health insurance
  • signed informed consent

Exclusion Criteria:

  • prior cancer
  • mesothelioma and oesophageal cancer
  • unable to undergo trail medical follow up (geographical, social and psychological reasons)
  • pregnant or nursing woman
  • patient under guardianship

Sites / Locations

  • Oscar Lambret Center
  • Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
  • Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

systematic addiction consultation
difference between abstinence in group A and abstinence in group B

Secondary Outcome Measures

progression free survival
median time between date of inclusion and date of first progression
overall survival
median time between date of inclusion and date of death
alcohol and tobacco consumption
frequency of tobacco and alcohol consumption questionnaire : Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut Down Annoyed Guilty Eye-Opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I.
alcohol + tobacco withdrawal and addiction support
difference between abstinence of group A and abstinence group B
addiction follow up
percentage of patient with a first addiction consultation, and willing to have a long term follow up

Full Information

First Posted
July 26, 2012
Last Updated
January 23, 2018
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT01652456
Brief Title
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Official Title
Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
Keywords
addiction support, addiction specialist, lung cancer, head and neck cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Addiction support
Intervention Description
one consultation with an addiction specialist
Primary Outcome Measure Information:
Title
systematic addiction consultation
Description
difference between abstinence in group A and abstinence in group B
Time Frame
12 months after diagnosis
Secondary Outcome Measure Information:
Title
progression free survival
Description
median time between date of inclusion and date of first progression
Time Frame
24 months after diagnosis
Title
overall survival
Description
median time between date of inclusion and date of death
Time Frame
24 months after survival
Title
alcohol and tobacco consumption
Description
frequency of tobacco and alcohol consumption questionnaire : Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut Down Annoyed Guilty Eye-Opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I.
Time Frame
baseline, 3 months, 6 months and 12 months after diagnosis
Title
alcohol + tobacco withdrawal and addiction support
Description
difference between abstinence of group A and abstinence group B
Time Frame
12 months after diagnosis
Title
addiction follow up
Description
percentage of patient with a first addiction consultation, and willing to have a long term follow up
Time Frame
24 months after diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first head and neck or lung cancer first support 18 ≤ age ≤ 60 lives in Lille Metropolis having an addiction to alcohol and tobacco covered by health insurance signed informed consent Exclusion Criteria: prior cancer mesothelioma and oesophageal cancer unable to undergo trail medical follow up (geographical, social and psychological reasons) pregnant or nursing woman patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne VANNIMENUS, MD
Organizational Affiliation
Centre Hospitalier Régional et Universitaire
Official's Role
Study Director
Facility Information:
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59 020
Country
France
Facility Name
Centre Hospitalier Régional et Universitaire - Hopital CALMETTE
City
Lille
ZIP/Postal Code
59 037
Country
France
Facility Name
Centre Hospitalier Régional et Universitaire - Hopital HURIEZ
City
Lille
ZIP/Postal Code
59 037
Country
France

12. IPD Sharing Statement

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Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support

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