NCT03102229已完成不适用
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
研究概览
简要总结
This study will aim to demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.
详细描述
Primary Objective
- To demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.
Secondary Objectives
- To demonstrate the feasibility of a program of rapid, multidisciplinary supportive care triggered by real-time pedometer data.
- To characterize the interventions enacted by our multidisciplinary supportive care team.
- To explore if interventions enacted by our multidisciplinary team for patients with low recent step counts lead to increased step counts in subsequent weeks compared to historical controls.
- To collect biospecimens for future correlative studies examining associations between blood/urine biomarkers and patient activity levels.
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
- •Age > 18
- •ECOG performance status 0-2
- •Able to ambulate independently (without the assistance of a cane or walker)
- •Diagnosis of invasive malignancy of the head and neck region, lung, esophagus, or stomach
- •Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment)
- •Women of childbearing potential must:
- •Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
- •Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
- •Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
- •All patients must sign study specific informed consent prior to study entry.
排除标准
- 未提供
研究组 & 干预措施
Activity Monitoring
Experimental
- Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks
- Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals
干预措施: Enhanced Supportive Care - Status Checks (Other)
Activity Monitoring
Experimental
- Enhanced Supportive Care - Status Checks Would occur everyday during treatment when a patient is deemed high-risk based on activity level. Other Names: •Daily Status Checks
- Enhanced Supportive Care - Referrals On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor. Other Names: •Referrals
干预措施: Enhanced Supportive Care - Referrals (Other)
结局指标
主要结局
Number of patients hospitalized during treatment or within 4 weeks after completing radiotherapy.
时间窗: During chemoradiotherapy or within 4 weeks after completion of radiotherapy.
The primary endpoint of this study is hospitalization during chemoradiotherapy or within 4 weeks after completion of radiotherapy.
次要结局
- Treatment-related toxicities(During chemoradiotherapy or within 4 weeks after completion of radiotherapy.)
- Disease status(During chemoradiotherapy and up to two years after completion of radiotherapy.)
- Survival status(During chemoradiotherapy and and up to two years after completion of radiotherapy.)
- Frequency of clinician visits and supportive care measures implemented.(During chemoradiotherapy or within 4 weeks after completion of radiotherapy)
- Activation of the enhanced supportive care protocol(During chemoradiotherapy or within 4 weeks after completion of radiotherapy.)
- Patient-reported quality of life scores(During chemoradiotherapy or within 4 weeks after completion of radiotherapy.)
- Modified Glasgow Prognostic Score(From time of registration to up to 4 weeks after completion of radiotherapy.)
研究者
Nitin Ohri
Associate Professor
Albert Einstein College of Medicine
研究点 (1)
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