An Observational Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 10
- 主要终点
- ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
研究概览
简要总结
The current research is a non-interventional (NIS) study seeking to support objective Performance Status (PS) assessments in the particular context of metastatic NSCLC adult patients. To do so, the study comprises two phases. Phase I addresses a feasibility mixed-methods (quantitative-qualitative) approach. It primarily focuses on examining perceived technology usability in a limited sample of participants and feasibility of translating the actigraph data into PS scores (focus expert group). Phase II focuses on to primarily examine associations between technology collected data and ECOG-PS in a larger sample of participants.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
ECOG-PS assessment of LC participants measured by data collected through wearable and a mobile application
时间窗: From baseline up to 9 months
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Usability of the wearable device perceived by clinical investigators
时间窗: From baseline up to 9 months
System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
Usability of the wearable device perceived by LC participants
时间窗: From baseline up to 9 months
System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
Usability of the mobile application perceived by clinical investigators
时间窗: From baseline up to 9 months
System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
ECOG-PS assessment of LC participants measured by clinical investigators
时间窗: From baseline up to 9 months
ECOG-PS: Eastern Cooperative Oncology Group Performance Status (Oken et al., 1982)
Usability of the mobile application perceived by LC participants
时间窗: From baseline up to 9 months
System Usability: SUS questionnaire (Brooke, 1986) and usability questionnaire adapted from (Kim et al., 2017). This is a 10-item scale based on a 5-point Likert response measuring strength and agreement of usability. Total scores range from 0 to 100 with score = 68 considered acceptable usability.
次要结局
- Sensitivity to changes in ECOG-PS over time measured by wearable and mobile application(From baseline up to 9 months)
- Sensitivity to changes in ECOG-PS over time measured by clinical investigators(From baseline up to 9 months)