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Completed

NCT Number: NCT04048954

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

All MD

Le Mans, 72000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Applitabac

Device

Smartphone application in screening on tabagism complications

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

    Time frame: 12 weeks

    Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout

Secondary outcomes

  1. Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018

    Time frame: first and second year of follow-up

    Proportion of patients operated on for lung cancer during the first and second year of follow-up in comparaison of 2017/2018

  2. Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up

    Time frame: first and second year of follow-up

    Proportion of diagnosed lung cancers, by stage and total first and second year of follow-up

  3. Stage of lung cancer surgery with Applitabac first and second year of follow-up

    Time frame: first and second year of follow-up

    Stage of lung cancer surgery with Applitabac first and second year of follow-up

  4. Histological stage of diagnosed lung cancer

    Time frame: second year of follow-up

    Histological stage of diagnosed lung cancer

  5. Stages of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up

    Time frame: 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

  6. Proportion of other cancers of Applitabac users diagnosed with Applitabac in the first and second year of follow-up

    Time frame: 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

  7. Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up

    Time frame: first and second year of follow-up

    Proportion of Applitabac-induced thoracic interventions without a cancer diagnosis first and second year of follow-up

  8. Proportion of patients with another pathology detected by Applitabac in the first and second year of follow-up

    Time frame: 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

  9. Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)

    Time frame: second year of follow-up

    Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)

  10. Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods

    Time frame: Two years before use of Applitabac

    Distribution of the stages of operated lung cancer, the two years preceding the implementation of Applitabac over similar periods

  11. Compare the distribution of the stages of operated patients (app vs. not app)

    Time frame: second year of follow-up

    Compare the distribution of the stages of operated patients (app vs. not app)

  12. Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)

    Time frame: second year of follow-up

    Comparison of the stage distribution of patients operated before / after implementation of the application (via Epithor data base)

  13. Number of users who want to quit after first use

    Time frame: 30 minutes after application implementation

    Number of users who want to quit after first use

Sponsors and collaborators

Lead sponsor

Weprom

Other

Collaborators

  • Department of Sarthe (72)
  • Le Mans Town Hall (72)

Registry information

Official study title

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

Acronym: APPLITABAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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