RAMP (Remote Activity Monitoring Pilot): A Feasibility Study Investigating Daily Step and Sleep Data in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Percentage of time patients wear the Fitbit Charge 3 device (compliance)
研究概览
简要总结
This pilot trial studies remote activity monitored by Fitbit Charge 3 in investigating daily step and sleep data in participants with head and neck cancer who are undergoing radiation therapy. A wearable remote activity tracking device, such as the Fitbit Charge 3, may help to detect early signs of treatment or disease-related symptoms, improve quality of life, decrease emergency room visits, and decrease hospitalizations in participants with head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine compliance with remote activity monitoring (RAM) in patients receiving radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC).
SECONDARY OBJECTIVES:
I. Evaluate feasibility of recruitment to the Remote Activity Monitoring Pilot (RAMP).
II. Investigate patient acceptability of RAM. III. Evaluate compliance with electronic patient-reported outcomes (ePROs) in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subjects have head and neck cancer as defined in history and physical
- •Patients are eligible to be treated with RT or CRT and plan to start treatment
- •Patients are capable of giving informed consent
- •Patients must be able to read and/or to speak English
- •Patients who are 18 years of age or older
- •Women of reproductive potential should have a negative serum or urine pregnancy test within the week prior to radiation CT planning scan
排除标准
- •Patients who cannot read or speak English
- •Patients who are not candidates for RT/CRT treatment.
- •Women of childbearing potential who are pregnant or breastfeeding
结局指标
主要结局
Percentage of time patients wear the Fitbit Charge 3 device (compliance)
时间窗: Through study completion, an average of 3 months
Daily compliance with remote activity monitoring (RAM) will be defined as wearing the device for 19/24 hours daily (80% daily use). Overall study period compliance will be defined as usage of the device for at least 70% of the days under observation where it should have been worn. The overall study period compliance rate along with a one-sided exact 95% confidence interval will be estimated.
次要结局
未报告次要终点