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

NCT04048954 | Completed

• 2 other identifiers: WP-2019-01NR1512030619
• Study Type: observational
• Target: 5,671
• Locations: 1 country
• Sites: 1

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.

Conditions

Tabagism; Lung Cancer; Chronic Obstructive Pulmonary Disease

Keywords

Screening; Tabagism; Chronic Obstructive Pulmonary Disease; Cancer; Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

  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

  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

Study Arms (1)

APPLITABAC arm

Use of a smartphone application on screening for complications related to tabagism

Device: Applitabac

Interventions

Applitabac DEVICE

Smartphone application in screening on tabagism complications

APPLITABAC arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Smoker or former smoker

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weprom: lead
• Le Mans Town Hall (72): collaborator
• Department of Sarthe (72): collaborator

Study Sites (1)

All MD

Le Mans, 72000, France

Location

Related Publications (3)

• 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.

  PMID: 30667494 RESULT

• 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.

  PMID: 25461805 RESULT

• 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.

  PMID: 35195530 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 7, 2019
• Study Start: May 30, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 18, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)