A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
研究概览
简要总结
This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.
详细描述
PRIMARY OBJECTIVES:
I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.
SECONDARY OBJECTIVES:
I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 are capable of giving informed consent
- •Patients are eligible to be treated with RT and plan to start treatment
- •Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
- •Patients must be able to read or speak English
- •Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan
排除标准
- •Patients who cannot read or speak English
- •Patients who are not candidates for RT treatment
- •Women of childbearing potential who are pregnant or breastfeeding
结局指标
主要结局
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
时间窗: Up to 4 weeks post-radiation therapy
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
时间窗: Up to 4 weeks post-radiation therapy
The 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