NCT04934865已完成不适用
Real Life Prospective Multicentric Study Evaluating the Clinical and Organisational Impact of Moovcare® Lung Connected Medical Device in Lung Cancer Patients : REAL-MOOV-LUNG
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 15
- 主要终点
- Proportion of patients.
研究概览
简要总结
Evaluation of patient's proportion, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.
详细描述
Primary objective of the study:
The primary objective is a clinical one and is to evaluate the proportion of patients, whose management care has been modified at least once and specially by Moovcare® Lung application at 12 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with lung cancer at any diagnostic stage and histology.
- •Patient willing to use the follow-up setting with Moovcare® Lung apps.
- •Age ≥ 18 years.
- •Patient received anti-cancer treatment (surgery, chemotherapy, radiation (stereotaxy or not) or radio-chemotherapy association ended less than 12 weeks (Cohort 1 post-treatment); or during maintenance treatment or consolidation by chemotherapy or targeted therapy, or by immunotherapy initiated less than 12 weeks (Cohort 2 during treatment).
- •Imaging tumor evaluation less than 12 weeks showing disease control (response or stability according to RECIST 1.1 criteria).
- •Patient with symptomatic score on Moovcare® Lung apps less than
- •Patient (or relatives) with internet access, a personnal e-mail box and a smartphone.
- •Patient with social security affiliation.
- •Signed informed consent form.
排除标准
- •Patient with progression after the first evaluation of initial treatment.
- •Pregnancy and breast-feeding.
- •Patient under tutorship or guardianship.
- •Dementia, mental alteration or psychiatric pathology influencing patient consent procedure and/or protocol observance and study follow-up.
- •Patient enable to protocol follow-up for psychological, social, familial or geographical reasons.
研究组 & 干预措施
Patients treated for their lung cancer and Moovcare® Lung follow-up.
Other
干预措施: Patients treated for their lung cancer. (Device)
结局指标
主要结局
Proportion of patients.
时间窗: 12 months
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at 12 months.
Proportion of patients.
时间窗: 24 months
Proportion of patients whose care management was modified at least once and specifically by Moovcare® Lung application at months.
次要结局
- Organizational aspects : Functioning and processing of alerts :(24 months)
- Clinical aspects : Duration of unscheduled hospitalizations.(24 months)
- Clinical aspects : Duration of overall hospitalizations.(24 months)
- Organizational aspects : Time for each investigating center(24 months)
- Clinical aspects : Number of unscheduled hospitalizations.(24 months)
- Clinical aspects : date of consultation.(24 months)
- Clinical aspects : Number of overall hospitalizations.(24 months)
- Clinical aspects : Overall survival over the entire follow-up.(24 months)
- Clinical aspects : Quality of life.(Every 3 months until 24 months)
- Organizational aspects : number of stakeholders(24 months)
- Organizational aspects : Patient satisfaction.(3, 6, 12, 18 and 24 months of use of the application)
- Organizational aspects : Satisfaction of the care teams at 6 months follow-up.(6 months follow-up)
- Organizational aspects : Patient compliance.(24 months)
- Organizational aspects : all secondary outcome measures(12 months of follow-up)
研究者
研究点 (15)
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