Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- cancer fatigue--BFI
研究概览
简要总结
This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 years old;
- •diagnosis of cancer;
- •can continuous wearing bracelet for 14 days or more
排除标准
- •Unclear and unable to answer the questionnaire；
- •Not able to walk；
- •platelet <50,000/mm3；
- •ANC 500/cumm
研究组 & 干预措施
exercise
combine walking and elastic band exercise
干预措施: exercise (Behavioral)
usual care
as usual care
结局指标
主要结局
cancer fatigue--BFI
时间窗: Change from Baseline at 1 month.
severity of fatigue level; measurement tool: Brief Fatigue Index
cancer fatigue--BFI
时间窗: Change from Baseline post exercise 5 min
severity of fatigue level; measurement tool: Brief Fatigue Index
次要结局
- Physical Activity assessment--IPAQ(Change from Baseline post exercise 5 min)
- Chinese version of the Edmonton Symptom Assessment System，C-ESAS(Change from Baseline post exercise 5 min)
- Sleep quality--PSQI(Change from Baseline post exercise 5 min)
- Steps count(Change from Baseline post exercise 5 min)
- walking distance(Change from Baseline post exercise 5 min)
- strength ability(Change from Baseline post exercise 5 min)
- walking distance(Change from Baseline at 1 month.)
- Smart bracelet_Heart rate variability (HRV)(Continue wear bracelet five days to record HRV data.)
- strength ability(Change from Baseline at 1 month.)
- Physical Activity assessment--IPAQ(Change from Baseline at 1 month.)
- Steps count(Change from Baseline at 1 month.)
- Chinese version of the Edmonton Symptom Assessment System，C-ESAS(Change from Baseline at 1 month.)
- Sleep quality--PSQI(Change from Baseline at 1 month.)
研究者
Tsai-Wei Huang
Professor
Taipei Medical University