Get Your Rear In Gear Study: Feasibility of Using Fitness Tracker to Assess Activity Level and Toxicities in Patients With Localized/Advanced Colorectal Cancer: A Fox Chase Cancer Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of usage
研究概览
简要总结
Primary Objective
To assess the feasibility of activity tracking using Fitbit device in terms of compliance (defined as at least 75% of patients complying with instructions to wear the device, for at least 12 hours a day on at least 3 of the 4 assigned days) in patients undergoing therapy for localized and advanced colorectal cancer.
Secondary Objectives
- To determine if physician-assessed performance status correlates with FitbitTM assessed physical activity (using active-minutes data).
- To correlate baseline physical activity level as assessed by FitbitTM with incidence of grade III or higher toxicities experienced during treatment
- To assess correlation between patient reported treatment related toxicities (PRO-CTCAE) and objective physical activity as measured by FitbitTM in patients treated for localized or metastatic cancers treated with chemotherapy
- To correlate baseline and interval change in physical activity levels as assessed by FitbitTM with post-surgical outcomes including inpatient length of stay, perioperative complications, post-operative 30-day mortality, and time to adjuvant treatment initiation (in days)
详细描述
Same as above
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age 18 years or older
- •Have histologically confirmed colorectal adenocarcinoma (Stage II-IV)
- •Have an estimated life expectancy of greater than 3 months
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Should meet the following treatment arms:
- •Planned to undergo curative resection with or without neoadjuvant/adjuvant therapy for colorectal cancer (surgical arm);
- •Planned to undergo/undergoing systemic chemotherapy for localized/metastatic colorectal cancer - medical arm (patient enrolled on one arm may not enroll onto the other arm)
- •Able to participate in some degree of physical activity (i.e. walking)
- •Are undergoing treatment for their cancer at FCCC
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent
排除标准
- •Inability to communicate in English.
- •Already using a personal activity tracker
- •Enrolled in another study in which physical activity is part or all of the therapeutic intervention or is being evaluated
- •Pre-existing toxicity >grade II
- •PS >3 for any reason
结局指标
主要结局
Rate of usage
时间窗: 4 days
To assess the feasibility of activity tracking using Fitbit device in terms of compliance (defined as at least 75% of patients complying with instructions to wear the device, for at least 12 hours a day on at least 3 of the 4 assigned days) in patients undergoing therapy for localized and advanced colorectal cancer.
Steps
时间窗: enrollment to 7 days
tracker assessed step count
次要结局
未报告次要终点