Use of a Smartphone Application on the Detection of Complications Related to Smoking (APPLITABAC)

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).

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Lung Cancer; Tabagism
• Intervention / Treatment: Device: Applitabac

• Study Type: Observational
• Enrollment (Actual): 5671

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • All MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Smoker or former smoker

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
APPLITABAC arm; Use of a smartphone application on screening for complications related to tabagism	Device: Applitabac; Smartphone application in screening on tabagism complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	first and second year of follow-up
Histological stage of diagnosed lung cancer	Histological stage of diagnosed lung cancer	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	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	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	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	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)	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	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)	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)	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	30 minutes after application implementation

Collaborators and Investigators

• Sponsor: Weprom
• Collaborators: Le Mans Town Hall (72); Department of Sarthe (72)

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Screening; Lung; Chronic Obstructive Pulmonary Disease; Tabagism
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WP-2019-01; NR1512030619 (Other Identifier: INDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No