Smoking Cessation and Lung CancerNCT01955057
Study of Psychopathological Characteristics of Patient Smoking in Thoracic Oncology
An observational study of Smoking Cessation and Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation and Lung Cancer
- What is being tested?
- Research interviews, Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R) and Projective methods (Thematic apperception Test, Rorschach)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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 maintains an active smoking at the time of inclusion
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- Patient who has smoked at least one cigarette in the previous year of inclusion
- 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
Who cannot join
- 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
- Patient in an exclusion period
Trial locations and contacts
1 site in 1 country.
France1 site
Nouvel Hôpital Civil, Service de pneumologie, Unité de cancérologie thoracique, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
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.
- Conditions
- Smoking Cessation and Lung Cancer
- Being tested
- Research interviews, Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R), Projective methods (Thematic apperception Test, Rorschach), Carbon monoxide test
- Medical subject headings
- Smoking Cessation, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research interviewsBehavioural
Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R)Behavioural
Projective methods (Thematic apperception Test, Rorschach)Behavioural
Carbon monoxide testBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smokers with lung cancer | Not described Receives: Behavioral: Research interviews; Behavioral: Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R); Behavioral: Projective methods (Thematic apperception Test, Rorschach); Behavioral: Carbon monoxide test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking Cessation and Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan GRAFFI, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955057
- Sponsor's protocol ID
- 5579
- Status last verified
- Jun 2016
- First submitted
- 20 Sep 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psychopathological Characteristics of Patient Smoking in Thoracic Oncology
- ClinicalTrials.gov ID
- NCT01955057
- Acronym / sponsor ID
- 5579
- Conditions
- Smoking Cessation and Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers with lung cancer | – | Behavioral: Research interviews, Behavioral: Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R), Behavioral: Projective methods (Thematic apperception Test, Rorschach), Behavioral: Carbon monoxide test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research interviews | Behavioural | Smokers with lung cancer |
| Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R) | Behavioural | Smokers with lung cancer |
| Projective methods (Thematic apperception Test, Rorschach) | Behavioural | Smokers with lung cancer |
| Carbon monoxide test | Behavioural | Smokers with lung cancer |
Primary outcome
Composite indicator variable indicating the presence or absence of disturbance in one or more of the parameters evaluated: object relations, body, subject's choice.
Time frame: 2 months after inclusion
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.
Composite indicator variable indicating the presence or absence of disturbance in one or more of the parameters evaluated: object relations, body, subject's choice.
Time frame: 4 months after inclusion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan GRAFFI principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite indicator variable indicating the presence or absence of disturbance in one or more of the parameters evaluated: object relations, body, subject's choice. (time frame: 2 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.