Smoking CessationDISCO-SETNCT04833933
Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process (DISCO-SET)
An observational study of Smoking Cessation and Pulmonary Disease, Chronic Obstructive, run by Rennes University Hospital at 12 sites in France.
Trial summary
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation. Each year, 3-5% of smokers succeed in quitting in the general population. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Smoking Cessation, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Phone survey about smoking cessation process since intervention in DISCO trial
- How many people
- 120 participants
- Where
- 12 sitesFrance
- Study dates
- 7 Apr 2021to 7 Jul 2021
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Random sample of 120 patients from the subgroup of 544 patients who were active smokers at inclusion in the DISCO study two years ago
Who may be able to join
- Active smoker patient at inclusion in the DISCO study,
- No objection to participate in the study,
- Patient still followed in the active file of general practitioners' offices (GP).
- Patient's telephone and postal details available
Who cannot join
- Patient not physically or mentally able to complete the phone survey,
- Patient deceased,
- Patient not reachable despite 5 phone calls and message left on answering machine.
- Patient under curatorship, guardianship or safeguard of justice
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Emmanuelle FOURE-AMELOT
Bédée, Brittany Region, 35137
Béatrice NEGARET
Breteil, Brittany Region, 35160
Lucie DELATTE
Janzé, Brittany Region, 35150
Marie BROSSET
Miniac-Morvan, Brittany Region, 35540
Antoine MOUTEL
Redon, Brittany Region, 35600
Anna JARNO-JOSSE
Rennes, Brittany Region, 35000
Hoël CHARBONNEL
Rennes, Brittany Region, 35000
Romain NIFENECKER
Rennes, Brittany Region, 35000
Jean-Philippe DUGUEY
St-Malo, Brittany Region, 35400
Laurent LENOBLE
Sulniac, Brittany Region, 56250
Lucie MURGALE
Talensac, Brittany Region, 35160
Marieke SALACROUP
Tremblay, Brittany Region, 35460
About this study
Official title: Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.
Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.
Read more
Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.
The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.
The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.
- Being tested
- Phone survey about smoking cessation process since intervention in DISCO trial
- Keywords
- Tobacco use cessation devices, Electronic Nicotine Delivery Systems, Cross-Sectional Studies, Smokers, Primary Care
- Medical subject headings
- Smoking Cessation, Pulmonary Disease, Chronic Obstructive, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone survey about smoking cessation process since intervention in DISCO trialOther
We will conduct a phone survey at 2 years follow-up with a random sample of smoking patients at inclusion in DISCO trial, to know the evolution of their smoking habits, the quit attempts since the intervention and the modalities of these attempts.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Initially in DISCO trial : no intervention, usual care
In DISCO-SET trial : survey (the same in the 4 groups) Receives: Other: Phone survey about smoking cessation process since intervention in DISCO trial | |
| Questionnaire | Initially in DISCO trial : Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.
In DISCO-SET trial : survey (the same in the 4 groups) Receives: Other: Phone survey about smoking cessation process since intervention in DISCO trial | |
| Coordination | Initially in DISCO trial : Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).
In DISCO-SET trial : survey (the same in the 4 groups) Receives: Other: Phone survey about smoking cessation process since intervention in DISCO trial | |
| Questionnaire + Coordination | Initially in DISCO trial :
* Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.
* Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).
In DISCO-SET trial : survey (the same in the 4 groups) Receives: Other: Phone survey about smoking cessation process since intervention in DISCO trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of smoking patients with at least 1 episode of smoking cessation attempts of at least 28 days since inclusion in the DISCO study.
Measured: 2 years
Secondary outcomes (16)
Smoking cessation of at least 7 days
Number of patients with smoking cessation of at least 7 days in patients who had quit smoking by the day of the survey, since inclusion in DISCO study
Measured: 2 years
Smoking cessation of at least 28 days
Number of patients with smoking cessation of at least 28 days in patients who had quit smoking by the day of the survey, since inclusion in DISCO study
Measured: 2 years
Smoking cessation of at least 6 months
Number of patients with smoking cessation of at least 6 months in patients who had quit smoking by the day of the survey, since inclusion in DISCO study
Measured: 2 years
Smoking cessation attempts of 7 days
Number of patients with smoking cessation attempts of 7 days in active smoking patients at the day of the survey, since inclusion in DISCO
Measured: 2 years
Smoking cessation attempts of 28 days
Number of patients with smoking cessation attempts of 28 days in active smoking patients at the day of the survey, since inclusion in DISCO
Measured: 2 years
Smoking cessation attempts of 6 months
Number of patients with smoking cessation attempts of 6 months in active smoking patients at the day of the survey, since inclusion in DISCO
Measured: 2 years
Cumulative duration (days) of smoking cessation attempts since inclusion in DISCO study
Measured: 2 years
Change in daily tobacco consumption in cigarettes per day, compared to the consumption reported at inclusion in DISCO
Measured: 2 years
Change in daily tobacco consumption in cigarettes per day at least 50% on the day of the survey, compared to the consumption reported at inclusion in DISCO
Measured: 2 years
Percentage of patients who made their first smoking cessation attempt in their life since their inclusion in the DISCO study
Measured: 2 years
Percentage of patients who used each kind of heath professionnal aid and material cessation aid since their inclusion in the DISCO study
Measured: 2 years
Percentage of patients who have discussed smoking with their general practitioner and number of consultations where this was discussed since their inclusion in the DISCO study
Measured: 2 years
Percentage of general practitioners still in practice, available for this study and who have not changed their patient base
Measured: 2 years
Percentage of patients included with completed questionnaires in the sample of 120 patients, with percentage of refusals to participate, incomplete questionnaires and non-responders
Measured: 2 years
Average number of calls per patient before inclusion and per patient included with completed questionnaire
Measured: 2 years
Average number of trips per practitioners and per number of patients included in each practitioners
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start7 Apr 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LAVIOLLE, PhD, Study chair, Rennes UHAnthony CHAPRON, PhD, Principal investigator, Faculty of medicine of rennesAnthony CHAPRON, PhD, Study director, Faculty of medicine of rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833933
- Sponsor's protocol ID
- 35RC21_9742_DISCO-SET
- Acronym
- DISCO-SET
- Status last verified
- Nov 2021
- First submitted
- 2 Apr 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO
- ClinicalTrials.gov ID
- NCT04833933
- Acronym / sponsor ID
- DISCO-SET / 35RC21_9742_DISCO-SET
- Keywords
- Tobacco use cessation devices, Electronic Nicotine Delivery Systems, Cross-Sectional Studies, Smokers, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 6 Apr 2021 (actual)
- 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.
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.
Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.
Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.
The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.
The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Phone survey about smoking cessation process since intervention in DISCO trialInitially in DISCO trial : no intervention, usual care In DISCO-SET trial : survey (the same in the 4 groups) |
| Questionnaire | – | Other: Phone survey about smoking cessation process since intervention in DISCO trialInitially in DISCO trial : Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry. In DISCO-SET trial : survey (the same in the 4 groups) |
| Coordination | – | Other: Phone survey about smoking cessation process since intervention in DISCO trialInitially in DISCO trial : Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments). In DISCO-SET trial : survey (the same in the 4 groups) |
| Questionnaire + Coordination | – | Other: Phone survey about smoking cessation process since intervention in DISCO trialInitially in DISCO trial : * Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry. * Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments). In DISCO-SET trial : survey (the same in the 4 groups) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample of 120 patients from the subgroup of 544 patients who were active smokers at inclusion in the DISCO study two years ago
Key inclusion criteria (4 listed)
- Active smoker patient at inclusion in the DISCO study,
- No objection to participate in the study,
- Patient still followed in the active file of general practitioners' offices (GP).
- Patient's telephone and postal details available
Key exclusion criteria (4 listed)
- Patient not physically or mentally able to complete the phone survey,
- Patient deceased,
- Patient not reachable despite 5 phone calls and message left on answering machine.
- Patient under curatorship, guardianship or safeguard of justice
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 |
|---|---|---|
| Phone survey about smoking cessation process since intervention in DISCO trialWe will conduct a phone survey at 2 years follow-up with a random sample of smoking patients at inclusion in DISCO trial, to know the evolution of their smoking habits, the quit attempts since the intervention and the modalities of these attempts. | Other | Control group, Coordination, Questionnaire, Questionnaire + Coordination |
Primary outcome
Percentage of smoking patients with at least 1 episode of smoking cessation attempts of at least 28 days since inclusion in the DISCO study.
Time frame: 2 years
16 secondary outcomes
Smoking cessation of at least 7 days
Time frame: 2 years
Smoking cessation of at least 28 days
Time frame: 2 years
Smoking cessation of at least 6 months
Time frame: 2 years
Smoking cessation attempts of 7 days
Time frame: 2 years
Smoking cessation attempts of 28 days
Time frame: 2 years
Smoking cessation attempts of 6 months
Time frame: 2 years
Cumulative duration (days) of smoking cessation attempts since inclusion in DISCO study
Time frame: 2 years
Change in daily tobacco consumption in cigarettes per day, compared to the consumption reported at inclusion in DISCO
Time frame: 2 years
Change in daily tobacco consumption in cigarettes per day at least 50% on the day of the survey, compared to the consumption reported at inclusion in DISCO
Time frame: 2 years
Percentage of patients who made their first smoking cessation attempt in their life since their inclusion in the DISCO study
Time frame: 2 years
Percentage of patients who used each kind of heath professionnal aid and material cessation aid since their inclusion in the DISCO study
Time frame: 2 years
Percentage of patients who have discussed smoking with their general practitioner and number of consultations where this was discussed since their inclusion in the DISCO study
Time frame: 2 years
Percentage of general practitioners still in practice, available for this study and who have not changed their patient base
Time frame: 2 years
Percentage of patients included with completed questionnaires in the sample of 120 patients, with percentage of refusals to participate, incomplete questionnaires and non-responders
Time frame: 2 years
Average number of calls per patient before inclusion and per patient included with completed questionnaire
Time frame: 2 years
Average number of trips per practitioners and per number of patients included in each practitioners
Time frame: 2 years
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 17 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Bruno LAVIOLLE, PhD study chair
Rennes UH
Anthony CHAPRON, PhD principal investigator
Faculty of medicine of rennes
Anthony CHAPRON, PhD study director
Faculty of medicine of rennes
12 sites 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 Pulmonary Disease, Chronic Obstructive, run by Rennes University Hospital at 12 sites 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 4 inclusion and 4 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 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Percentage of smoking patients with at least 1 episode of smoking cessation attempts of at least 28 days since inclusion in the DISCO study. (time frame: 2 years). 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 17 Nov 2021.