Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of patient accrual
研究概览
简要总结
This is an observational study to investigate if it is feasible to recruit 100 patients receiving radiotherapy (RT) to metastatic disease to wear Hexoskin and if Hexoskin will facilitate the monitoring, detection and early treatment of RT-related side effects.
详细描述
Radiotherapy is an important adjunct in the interdisciplinary care of the palliative patient population, providing the potential for improved quality of life and symptom control, often translating into improved well-being, function and mobility. Changes in pain and QOL are frequently measured subjectively using patient-reported questionnaires. Objective measures such as respiratory rate, pulse rate, activity level and sleep duration and quality, may complement the currently available tools. Such tools may lead to better evaluation of the effects of palliative RT with real-time detection of potential complications and toxicity and the acute need for analgesic adjustments that can result from successful palliative RT.
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
- •Planned to receive palliative radiotherapy for pain
- •Known cancer diagnosis
- •Able to wear Hexoskin Medical Shirt
- •Ability to use and populate the mobile app (Zamplo) with or without assistance
- •ECOG: 0-3
- •Willing to provide a list of analgesic (pain relief) medication
- •Willing to complete questionnaires
- •Life expectancy of at least 3 months
排除标准
- •Receiving whole brain radiotherapy
- •Major cognitive or psychiatric impairments
- •Pregnant women
- •Allergies to: polyester, synthetic fibers
- •Patients with pacemakers or implantable cardioverter-defibrillator (ICD)
- •Patients on a Holter Monitor
结局指标
主要结局
Rate of patient accrual
时间窗: Over 12 months
Feasibility of accruing 100 patients to the study
Frequency of radiotherapy related adverse events
时间窗: Baseline to 12 months
Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.
次要结局
- Number of Trial Refusals(Baseline to 12 months)
- Quality of Life (QOL) survey completion(Baseline to 12 months)
- Characterize adverse event profile(Baseline to 12 months)
- Complete follow-ups(Baseline to 12 months)
- Quality Adjusted Life Years (QALY)(Baseline to 12 months)
- Hexoskin data collection rates(Baseline to 12 months)
- Patient Adherence(Baseline to 12 months)
- Health Related Quality of Life (QOL)(Baseline to 12 months)
- Overall survival of participants(Baseline to 12 months)
- Patient experience and satisfaction(Baseline to 12 months)