NCT04833933

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

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

April 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

April 2, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

Tobacco use cessation devicesElectronic Nicotine Delivery SystemsCross-Sectional StudiesSmokersPrimary Care

Outcome Measures

Primary Outcomes (1)

  • Percentage of smoking patients with at least 1 episode of smoking cessation attempts of at least 28 days since inclusion in the DISCO study.

    2 years

Secondary Outcomes (16)

  • Smoking cessation of at least 7 days

    2 years

  • Smoking cessation of at least 28 days

    2 years

  • Smoking cessation of at least 6 months

    2 years

  • Smoking cessation attempts of 7 days

    2 years

  • Smoking cessation attempts of 28 days

    2 years

  • +11 more secondary outcomes

Study Arms (4)

Control group

Initially in DISCO trial : no intervention, usual care In DISCO-SET trial : survey (the same in the 4 groups)

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)

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)

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)

Other: Phone survey about smoking cessation process since intervention in DISCO trial

Interventions

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.

Control groupCoordinationQuestionnaireQuestionnaire + Coordination

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Emmanuelle FOURE-AMELOT

Bédée, Brittany Region, 35137, France

Location

Béatrice NEGARET

Breteil, Brittany Region, 35160, France

Location

Lucie DELATTE

Janzé, Brittany Region, 35150, France

Location

Marie BROSSET

Miniac-Morvan, Brittany Region, 35540, France

Location

Antoine MOUTEL

Redon, Brittany Region, 35600, France

Location

Anna JARNO-JOSSE

Rennes, Brittany Region, 35000, France

Location

Hoël CHARBONNEL

Rennes, Brittany Region, 35000, France

Location

Romain NIFENECKER

Rennes, Brittany Region, 35000, France

Location

Jean-Philippe DUGUEY

St-Malo, Brittany Region, 35400, France

Location

Laurent LENOBLE

Sulniac, Brittany Region, 56250, France

Location

Lucie MURGALE

Talensac, Brittany Region, 35160, France

Location

Marieke SALACROUP

Tremblay, Brittany Region, 35460, France

Location

MeSH Terms

Conditions

Smoking CessationPulmonary Disease, Chronic ObstructiveVaping

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSmoking

Study Officials

  • Bruno LAVIOLLE, PhD

    Rennes UH

    STUDY CHAIR
  • Anthony CHAPRON, PhD

    Faculty of medicine of rennes

    PRINCIPAL INVESTIGATOR
  • Anthony CHAPRON, PhD

    Faculty of medicine of rennes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 6, 2021

Study Start

April 7, 2021

Primary Completion

July 7, 2021

Study Completion

July 7, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations