Prospective Study Evaluating the Impact of the Use of a Smartphone Application on the Detection of Complications Related to Smoking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,671
- 试验地点
- 1
- 主要终点
- Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Presence of another evolutionary neoplasia in the past 2 years
- •Patient who did not use the Applitabac app
结局指标
主要结局
Proportion of patients fit for surgery for a symptomatic stage I-II lung cancer during the 12 weeks after the web-application rollout
时间窗: 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
次要结局
- 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)
- Histological stage of diagnosed lung cancer(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)
- 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)
- Compare the distribution of the stages of operated patients (app vs. not app)(second year of follow-up)
- Stage of diagnosis of COPD detected by the application (GOLD classification : VEMS)(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)
- 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 patients with another pathology detected by Applitabac in the first and second year of follow-up(first and second year of follow-up)
- 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)
- 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(30 minutes after application implementation)