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

NCT ID: NCT04048954

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-30

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Tabagism Lung Cancer Chronic Obstructive Pulmonary Disease

Keywords

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Screening Tabagism Chronic Obstructive Pulmonary Disease Cancer Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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APPLITABAC arm

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

Applitabac

Intervention Type DEVICE

Smartphone application in screening on tabagism complications

Interventions

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Applitabac

Smartphone application in screening on tabagism complications

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Le Mans Town Hall (72)

UNKNOWN

Sponsor Role collaborator

Department of Sarthe (72)

UNKNOWN

Sponsor Role collaborator

Weprom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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All MD

Le Mans, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30667494 (View on PubMed)

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.

Reference Type RESULT
PMID: 25461805 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35195530 (View on PubMed)

Other Identifiers

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NR1512030619

Identifier Type: OTHER

Identifier Source: secondary_id

WP-2019-01

Identifier Type: -

Identifier Source: org_study_id