Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Percentage of patients whose wearable activity monitor provides movement data
研究概览
简要总结
This clinical trial studies movement tracking devices in optimizing and monitoring physical activity in patients with solid tumors undergoing chemotherapy in a health care facility during the day without spending the night. Movement tracking devices, such as Microsoft Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.
SECONDARY OBJECTIVES:
I. To evaluate the association between activity and patient reported fatigue. II. To evaluate the association between movement and incidents of health care interventions (hospitalizations, physical visits, intravenous hydration, etc.)
TERTIARY OBJECTIVES:
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
- •A diagnosis of a solid tumor, undergoing palliative or adjuvant therapy
- •Undergoing at least 2 planned cycles of highly emetogenic chemotherapy defined according to the Hekseth scale; the cycles may range in duration from 14 days to 28 days, according to standard of care practices
- •Ability to understand and the willingness to sign a written informed consent
- •Willingness to wear sensors to track physical activity, Global Positioning System (GPS) location, and provide symptom ratings each night for up to 60 days
- •Able to read English, Spanish, or Traditional Mandarin to complete patient reported outcomes
- •Able to ambulate without an assistive device
- •Able to operate a smartphone and wearable wristband
排除标准
- •Patients may not be missing limbs
- •Patient does not have a diagnosis of a hematologic malignancy
- •Patients with symptomatic brain metastases are excluded from this clinical trial; those with asymptomatic brain metastasis are permitted; it is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis
- •Patient with a known movement disorder such as Parkinson's disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
结局指标
主要结局
Percentage of patients whose wearable activity monitor provides movement data
时间窗: Up to 60 days
Percent of patients who achieve "data capture success" defined as having both PRO data and accelerometry data transmitted to the investigators in 80% of the observation days
时间窗: Up to 60 days
Patients who are unable to comply and have data transmitted, including technical failures, personal decision, hospitalization, or any other reason are counted as "data capture failures". Data from patients who die while on study will not be replaced but will be included prior to their date of death, days between death and day 60 will not be included in the denominator when calculating "data capture success" rates.
次要结局
- Change in weight over time(Baseline to 60 days)