Clinical trial NCT04048954: Use of a Smartphone Application on the Detection of Complications Related to Smoking
Official title: Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tabagism
Lung Cancer
Chronic Obstructive Pulmonary Disease
Keywords: Screening
Tabagism
Chronic Obstructive Pulmonary Disease
Cancer
Lung
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Le Mans Town Hall (72)
name: Department of Sarthe (72)
First posted: 2019-08-07
Enrollment: 5671
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smoker or former smoker

Brief 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% 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of another evolutionary neoplasia in the past 2 years
* Patient who did not use the Applitabac app

Primary outcomes:
measure: Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018
timeFrame: first and second year of follow-up
measure: Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Stage of lung cancer surgery with Applitabac first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Histological stage of diagnosed lung cancer
timeFrame: second year of follow-up
measure: Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up
timeFrame: first and second year of follow-up
measure: Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)
timeFrame: second year of follow-up
measure: Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods
timeFrame: Two years before use of Applitabac
measure: Compare the distribution of the stages of operated patients (app vs. not app)
timeFrame: second year of follow-up
measure: Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)
timeFrame: second year of follow-up
measure: Number of users who want to quit after first use
timeFrame: 30 minutes after application implementation
Other outcomes:
Locations:
city: Le Mans
country: France
facility: All MD
Study officials:
References:
citation: 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.
citation: Ironmonger 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.
citation: Stavaux 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.