Monitoring and Telecoaching of Physical Activity in Patients With Stage III and IV Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in average daily number of steps
研究概览
简要总结
This study is a prospective non-randomised control study to evaluate the efficacy of a physical activity promotion program on the experience of physical activity in patients with stage III and IV non-small cell lung cancer (NSCLC) with documented disease control (stable disease, partial or complete response defined by RECIST V1.1) at least 6 months after start of first line treatment.
The trial will consist of 4 visits. An outpatient clinic visit in which the eligible patients are invited (V1), a screenings visit (V2), a third visit (V3) at which the patients will be divided into the intervention or the control group, according to owning a smartphone and their affinity with it, followed by the start of the intervention consisting of 8 weeks telecoaching by means of an application and step counter and a final visit (V4) 8 weeks after starting up the intervention.
详细描述
The objective of this pilot study is to investigate if physical activity can be improved by telecoaching in patients with advanced stages of lung cancer in remission. We hypothesize that a smartphone application, designed for a population with respiratory symptoms, will increase daily physical activity, which translates into significant improvements on quality of life. This uncontrolled pilot study will therefore address if a 8-week PA promotion telecoaching program in addition to usual care has the potential to improve physical activity and quality of life in patients with lung cancer for a limited burden and at low cost.
This trial consists of 4 visits:
Visit 1 (V1, outpatient clinic):
Patients will be screened for inclusion in the study during follow up visits in the outpatient lung cancer clinic. If oncological check-up 6 months after starting initial lung cancer treatment demonstrates objective response (partial response or complete response defined by RECIST V1.1) the patient is asked to join the study. If the patient wants to join the study a screening visit (V2) will be planned.
Visit 2 (V2, screening visit (run-in)):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients are evenly divided into the telecoaching group or usual care group according to owning a smartphone and their affinity with it.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control
Patients will only receive a brochure explaining the importance of physical activity with recommendations to improve it.
Telecoaching
Patients will receive a brochure explaining the importance of physical activity with recommendations to improve it. Next to this patients will receive the telecoaching intervention in which a coaching application linked to a step counter is installed on the patients smartphone, which will weekly give a new physical activity goal to improve the amount of steps per day for 8 weeks.
干预措施: Telecoaching (Device)
结局指标
主要结局
Change in average daily number of steps
时间窗: 8 weeks
To assess the impact of a telecoaching program on physical activity in patients with stage III and IV NSCLC in addition to usual care. This will be measured by the Dynaport movemonitor (Dynaport®), as the change in average daily number of steps at baseline (1 week preceding V3) and at the end (1 week preceding V4) in the intervention and the control group.
次要结局
- Change in health status(8 weeks)
- Change in exercise capacity(8 weeks)