NCT01652456

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

August 1, 2014

Enrollment Period

5.1 years

First QC Date

July 26, 2012

Last Update Submit

January 23, 2018

Conditions

Head and Neck CancerLung Cancer

Keywords

addiction supportaddiction specialistlung cancerhead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • systematic addiction consultation

    difference between abstinence in group A and abstinence in group B

    12 months after diagnosis

Secondary Outcomes (5)

  • progression free survival

    24 months after diagnosis

  • overall survival

    24 months after survival

  • alcohol and tobacco consumption

    baseline, 3 months, 6 months and 12 months after diagnosis

  • alcohol + tobacco withdrawal and addiction support

    12 months after diagnosis

  • addiction follow up

    24 months after diagnosis

Study Arms (2)

Group A

EXPERIMENTAL
Other: Addiction support

Group B

NO INTERVENTION

Interventions

Addiction supportOTHER

one consultation with an addiction specialist

Group A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oscar Lambret Center

Lille, 59 020, France

Location

Centre Hospitalier Régional et Universitaire - Hopital CALMETTE

Lille, 59 037, France

Location

Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

Lille, 59 037, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Corinne VANNIMENUS, MD

    Centre Hospitalier Régional et Universitaire

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 30, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 24, 2018

Record last verified: 2014-08

Locations

FR(3)