TabagismAPPLITABACNCT04048954
Use of a Smartphone Application on the Detection of Complications Related to Smoking
An observational study of Tabagism and Lung Cancer, run by Weprom at 1 site in France.
Trial summary
Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage. Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8%… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tabagism, Lung Cancer, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Applitabac
- Type of treatment
- Medical device
- How many people
- 5,671 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2019to 1 Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Smoker or former smoker
Who may be able to join
- Age >= 18 years old
- Applitabac user who has received a notification directing him to his doctor
- Smoker or former smoker (current smoking cessation or ≤ 5 years)
- Patient informed of the use of his data and not opposing it
Who cannot join
- Presence of another evolutionary neoplasia in the past 2 years
- Patient who did not use the Applitabac app
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking
Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage.
Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8% of smokers after 7 years of establishment in the USA).
Read more
An English study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("You smoke, you cough for more than 3 weeks, consult").
Regarding COPD, it is linked to tobacco in 85% of cases, affects 3.5 million French and is in 2013 the 4th leading cause of death in France. The evolution of COPD is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. COPD remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in France.
Dr DENIS has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial.
The Applitabac app takes this concept of symptom self-assessment by patients. By multiplying the number of symptoms analyzed compared to the English study, Applitabac should be able to increase the sensitivity of this early detection of COPD and increase the number of operable bronchial cancers and increase the chances of survival of patients.
- Conditions
- Tabagism, Lung Cancer, Chronic Obstructive Pulmonary Disease
- Being tested
- Applitabac
- Keywords
- Screening, Tabagism, Chronic Obstructive Pulmonary Disease, Cancer, Lung
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApplitabacDevice
Smartphone application in screening on tabagism complications
| Study group | Role | What they receive |
|---|---|---|
| APPLITABAC arm | Use of a smartphone application on screening for complications related to tabagism Receives: Device: Applitabac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
Measured: 12 weeks
Secondary outcomes (13)
Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018
Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018
Measured: first and second year of follow-up
Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up
Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up
Measured: first and second year of follow-up
Stage of lung cancer surgery with Applitabac first and second year of follow-up
Stage of lung cancer surgery with Applitabac first and second year of follow-up
Measured: first and second year of follow-up
Histological stage of diagnosed lung cancer
Histological stage of diagnosed lung cancer
Measured: second year of follow-up
Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Measured: first and second year of follow-up
Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Measured: first and second year of follow-up
Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up
Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up
Measured: first and second year of follow-up
Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up
Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up
Measured: first and second year of follow-up
Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)
Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)
Measured: second year of follow-up
Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods
Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods
Measured: Two years before use of Applitabac
Compare the distribution of the stages of operated patients (app vs. not app)
Compare the distribution of the stages of operated patients (app vs. not app)
Measured: second year of follow-up
Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)
Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)
Measured: second year of follow-up
Number of users who want to quit after first use
Number of users who want to quit after first use
Measured: 30 minutes after application implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start30 May 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TabagismStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Le Mans Town Hall (72), Department of Sarthe (72)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048954
- Sponsor's protocol ID
- WP-2019-01
- Other IDs
- NR1512030619
- Acronym
- APPLITABAC
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.
PubMed 30667494Ironmonger L, Ohuma E, Ormiston-Smith N, Gildea C, Thomson CS, Peake MD. An evaluation of the impact of large-scale interventions to raise public awareness of a lung cancer symptom. Br J Cancer. 2015 Jan 6;112(1):207-16. doi: 10.1038/bjc.2014.596. Epub 2014 Dec 2.
PubMed 25461805Stavaux E, Goupil F, Barreau G, Septans AL, Dautzenberg B, Foulet-Roge A, Padilla N, Urban T, Denis F. Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. JMIR Public Health Surveill. 2022 Feb 23;8(2):e19877. doi: 10.2196/19877.
PubMed 35195530
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking
- ClinicalTrials.gov ID
- NCT04048954
- Acronym / sponsor ID
- APPLITABAC / WP-2019-01
- Conditions
- Tabagism, Lung Cancer, Chronic Obstructive Pulmonary Disease
- Keywords
- Screening, Tabagism, Chronic Obstructive Pulmonary Disease, Cancer, Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,671 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Le Mans Town Hall (72), Department of Sarthe (72)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 7 Aug 2019 (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.
Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage.
Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8% of smokers after 7 years of establishment in the USA).
An English study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("You smoke, you cough for more than 3 weeks, consult").
Regarding COPD, it is linked to tobacco in 85% of cases, affects 3.5 million French and is in 2013 the 4th leading cause of death in France. The evolution of COPD is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. COPD remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in France.
Dr DENIS has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial.
The Applitabac app takes this concept of symptom self-assessment by patients. By multiplying the number of symptoms analyzed compared to the English study, Applitabac should be able to increase the sensitivity of this early detection of COPD and increase the number of operable bronchial cancers and increase the chances of survival of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APPLITABAC arm | – | Device: ApplitabacUse of a smartphone application on screening for complications related to tabagism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Smoker or former smoker
Key inclusion criteria (4 listed)
- Age >= 18 years old
- Applitabac user who has received a notification directing him to his doctor
- Smoker or former smoker (current smoking cessation or ≤ 5 years)
- Patient informed of the use of his data and not opposing it
Key exclusion criteria (2 listed)
- Presence of another evolutionary neoplasia in the past 2 years
- Patient who did not use the Applitabac app
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 |
|---|---|---|
| ApplitabacSmartphone application in screening on tabagism complications | Device | APPLITABAC arm |
Primary outcome
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
Time frame: 12 weeks
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
13 secondary outcomes
Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018
Time frame: first and second year of follow-up
Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up
Time frame: first and second year of follow-up
Stage of lung cancer surgery with Applitabac first and second year of follow-up
Time frame: first and second year of follow-up
Histological stage of diagnosed lung cancer
Time frame: second year of follow-up
Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Time frame: first and second year of follow-up
Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
Time frame: first and second year of follow-up
Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up
Time frame: first and second year of follow-up
Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up
Time frame: first and second year of follow-up
Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)
Time frame: second year of follow-up
Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods
Time frame: Two years before use of Applitabac
Compare the distribution of the stages of operated patients (app vs. not app)
Time frame: second year of follow-up
Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)
Time frame: second year of follow-up
Number of users who want to quit after first use
Time frame: 30 minutes after application implementation
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 18 Nov 2020.
- Results publication: PubMed 30667494Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.
- Results publication: PubMed 25461805Ironmonger L, Ohuma E, Ormiston-Smith N, Gildea C, Thomson CS, Peake MD. An evaluation of the impact of large-scale interventions to raise public awareness of a lung cancer symptom. Br J Cancer. 2015 Jan 6;112(1):207-16. doi: 10.1038/bjc.2014.596. Epub 2014 Dec 2.
- Derived from this study: PubMed 35195530Stavaux E, Goupil F, Barreau G, Septans AL, Dautzenberg B, Foulet-Roge A, Padilla N, Urban T, Denis F. Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. JMIR Public Health Surveill. 2022 Feb 23;8(2):e19877. doi: 10.2196/19877.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tabagism and Lung Cancer, run by Weprom 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 4 inclusion and 2 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 18 Nov 2020. 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?
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048954, which also lists 3 linked publications.
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 18 Nov 2020.