Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- NRG Oncology
- 入组人数
- 3
- 试验地点
- 10
- 主要终点
- Occurrence of hospital admission
研究概览
简要总结
This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment.
详细描述
PRIMARY OBJECTIVE:
To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course.
SECONDARY OBJECTIVES:
I. To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial.
II. To examine the association between baseline activity level and clinical outcomes related to treatment tolerance, quality of life, chemoradiotherapy adverse events, and physical function preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathologically (histologically or cytologically) proven diagnosis of NSCLC
- •Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy. Expected treatment scenarios include:
- •Definitive treatment of stage III disease (most common)
- •Definitive treatment for locoregional recurrence of early stage disease
- •Definitive treatment of unresectable stage II disease
- •Preoperative treatment of stage III disease
- •Postoperative treatment after incomplete resection (uncommon)
- •Radical treatment for a patient with advanced/metastatic disease with the goal of achieving long-term thoracic disease control (e.g., oligometastatic disease where metastases are addressed with resection or stereotactic radiotherapy)
- •ECOG Performance Status 0-3 within 30 days prior to registration
- •Ambulates independently or with a cane (use of a walker not permitted)
- •Patients who already use wearable devices and/or smartphones that monitor physical activity are eligible for this trial. Patients must agree to wear the device provided by the study.
- •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
排除标准
- •Patients with a history of another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy for NSCLC
- •Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
- •Patients receiving thoracic radiotherapy without concurrent chemotherapy are ineligible. Patients receiving concurrent chemotherapy and another form of systemic therapy (e.g., immunotherapy) are eligible. Patients receiving radiotherapy with concurrent immunotherapy or targeted therapy but without chemotherapy are ineligible
研究组 & 干预措施
Arm I: Usual Care
Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy.
Arm II: Usual Care + Continuous physical activity monitoring via a wearable device
Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy along with continuous physical activity monitoring via a wearable device.
干预措施: Garmin Vivofit Activity Tracker (Other)
结局指标
主要结局
Occurrence of hospital admission
时间窗: From study enrollment to 1 month after radiotherapy completion.
Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours
时间窗: From study enrollment to 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours during radiation treatment or within 1 month after radiotherapy completion.
Occurrence of radiation treatment interruption
时间窗: From study enrollment to radiotherapy completion.
Occurrence of of radiation treatment interruption (missing two or more treatments, not due to machine issues or scheduled holidays) during radiation treatment.
次要结局
未报告次要终点