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

Lung Cancer Clinical Trial

— APPLITABAC  

Official title:

Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048954
• Other study ID #: WP-2019-01
• Secondary ID: NR1512030619
• Status: Completed
• Start date: May 30, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2019
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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% 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5671
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Tabagism

Intervention

Device:
• Applitabac
Smartphone application in screening on tabagism complications

Locations

Country	Name	City	State
France	All MD	Le Mans

Sponsors (3)

Lead Sponsor	Collaborator
Weprom	Department of Sarthe (72), Le Mans Town Hall (72)

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Histological stage of diagnosed lung cancer	Histological stage of diagnosed lung cancer	second year of follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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