NCT01955057

Brief Summary

Persistent smoking after lung cancer has been the subject of medical, therapeutic and epidemiological publications for twenty years of research. Continued persistent smoking is all the more a problem for oncologists as there is evidence that smoking cessation, with lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that adhesion differences aren't related to the denial of medical information, nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility to wean. Cigarette seems to be felt as a part of their body in their narration and description of their body image.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

September 20, 2013

Last Update Submit

June 8, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Composite indicator variable indicating the presence or absence of disturbance in one or more of the parameters evaluated: object relations, body, subject's choice.

    The results will be obtained: * From the results of each test, each has indeed a standardized rating scale * By analysing the content of the speech of the patient previously noted during the various interviews The investigator will classify each subject in "disturbance" or not for each of the three parameters. The presence of at least one disturbance gives the "yes" value in the indicator variable, "no" in the absence of the three disturbances.

    2 months after inclusion

  • Composite indicator variable indicating the presence or absence of disturbance in one or more of the parameters evaluated: object relations, body, subject's choice.

    The results will be obtained: * From the results of each test, each has indeed a standardized rating scale * By analysing the content of the speech of the patient previously noted during the various interviews The investigator will classify each subject in "disturbance" or not for each of the three parameters. The presence of at least one disturbance gives the "yes" value in the indicator variable, "no" in the absence of the three disturbances.

    4 months after inclusion

Study Arms (1)

Smokers with lung cancer

Behavioral: Research interviewsBehavioral: Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R)Behavioral: Projective methods (Thematic apperception Test, Rorschach)Behavioral: Carbon monoxide test

Interventions

Smokers with lung cancer
Smokers with lung cancer
Smokers with lung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited in the pneumology ward of Strasbourg University Hospital, precisely in hospitalization units involved in cancer care (Units 1404,1403,1202,2099)

You may qualify if:

  • Men and women aged 18 years or older
  • Patient affiliated to a social security system
  • Patient who has signed and dated informed consent, written before all procedures related to the study
  • Patient who has received the results of the previous mandatory medical examination
  • Patient who has been diagnosed with lung cancer, regardless of the histological type of the cancer
  • Patient who is being treated for lung cancer (surgery, chemotherapy, radiotherapy) and not another form of cancer
  • Tobacco consumer's only by smoke inhalation
  • Tobacco consumer's or tobacco associated with cannabis

You may not qualify if:

  • Major patient under guardianship or curatorship or maintenance of justice
  • Patient deprived of his liberty or in an emergency situation
  • Patient with a Performance Statut(OMS) higher than 2 and/or with a psychiatric disorder like " schizophrenia and other psychotic disorders " (DSM IV)
  • A palliative care patient
  • Patient who began smoking during his diagnostic examination or after the diagnosis of cancer
  • A pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouvel Hôpital Civil, Service de pneumologie, Unité de cancérologie thoracique, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Smoking CessationLung Neoplasms

Interventions

Thematic Apperception Test

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Projective TechniquesPersonality TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Jonathan GRAFFI

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 7, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations