NCT02457715已完成不适用
Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compliance rate of cancer and ALS patients using the device during a 14 week period.
研究概览
简要总结
This is a parallel group, single institution, prospective clinical study. The purpose of this study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a feasible tool to study physical activity in cancer patients and patients with Amyotrophic Lateral Sclerosis (ALS).
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
- •Patients > = 18 years of age.
- •Patient must be able to ambulate and complete the 6 minute walk test without use of a walker, cane, or any assist devices.
- •Cancer patients or ALS patients who meet the following criteria:
- •Prostate cancer:
- •Histologically confirmed prostate cancer.
- •Patients who are initiating any chemotherarpy (examples are docetaxel, cabazitaxel, etc.) and/or hormone directed treatment for prostate cancer. Examples of hormone directed therapy include GnRH agonist or antagonists (such as leuprolide, goserelin, triptorelin, histrelin and degarelix), androgen receptor blockers (such as bicalutamide or enzalutamide), or androgen biosynthesis inhibitors (such as abiraterone).
- •Renal cancer:
- •Histologically confirmed renal cell carcinoma (RCC).
- •Metastatic disease, in the opinion of the treating provider.
- •Starting any systemic therapy for metastatic disease
- •Brain cancer:
- •Histologically confirmed high grade glioma.
- •Status post concurrent radiation therapy and daily temozolomide.
- •Starting adjuvant temozolomide therapy.
- •ALS patients who are:
- •Already on a stable dose of Riluzole for at least one month.
- •ALSFRS-R with <or equal to 2 point decline in last month.
- •Must have ALSFRS-R walking score of at least 3 or 4 and FVC at least 50% (to ensure patients are fit enough for ambulation and physical activity).
- •Technology requirement:
- •Patients will need to own a smart phone that can interface with the Jawbone Up
- •Patients willing to provide their own internet access for this study. This will include either a data plan or Wi-Fi access on the patient's smart phone for use of the Jawbone App. They will also need internet access (through their smart phone or home computer) for setting up a SGHIx account. Patients are welcome to use the free guest Wi-Fi access within the Duke Outpatient clinic area for the purpose of this study.
- •Patients will need a home computer or adaptor with USB port to charge the Jawbone Up 24.
排除标准
- •Non-English Speaking or inability to read and understand English
- •Presence of cardiovascular disease that would make physical activity risky at the discretion of the provider.
- •Any patient who is unable to comprehend and operate the activity tracker at the discretion of the enrolling provider.
结局指标
主要结局
Compliance rate of cancer and ALS patients using the device during a 14 week period.
时间窗: 14 weeks
次要结局
- Karnofsky performance status in cancer patients.(14 weeks)
- Number of steps per day in cancer patients.(14 weeks)
研究者
研究点 (1)
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