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临床试验/NCT05330104
NCT05330104已完成不适用

SENSE Study: Feasibility of Using Continuous, Remote Symptom Monitoring to Identify and Respond to Early Fall-risk for Patients With Chemotherapy-induced Peripheral Neuropathy

Allina Health System1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年1月3日最近更新:
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
12
试验地点
1
主要终点
Patient satisfaction with mEMA

研究概览

简要总结

The main purpose of this study is to determine the threshold level of lower extremity CIPN symptoms that put patients who have been prescribed a neurotoxic chemotherapy agent (e.g., paclitaxel, docetaxel, oxaliplatin or cisplatin) as part of their treatment regimen for cancer at-risk for falling. The investigators believe that by specifying early CIPN symptoms that predict fall-risk, The investigators will ultimately be able to identify at-risk patients who could be referred to rehabilitative services to prevent injurious falls while enabling them to continue the chemotherapy treatment that could save their lives.

详细描述

Patients who are treated with neurotoxic chemotherapy as part of their cancer treatment regimen often experience lower extremity chemotherapy-induced peripheral neuropathy (CIPN) that causes motor and sensory loss, which increases their fall risk. CIPN is a potential side-effect of many chemotherapy regimens used to treat the most common adult cancers. In fact, CIPN occurs in as many as 90% of cancer patients whose chemotherapy includes taxanes, vinca alkaloids, or platinum agents. The symptoms of CIPN affect balance, which may put patients at-risk for falls. While much of the research in this area pertains to participants with long-standing CIPN symptoms, most authorities explicitly advocate for early monitoring for symptoms of CIPN and for earlier intervention than is currently the standard of care. However, there is little scientific literature that specifies (1) when in patients' chemotherapy regimens these symptoms typically first reach a significant CIPN or fall/near fall symptom threshold, and (2) how to best systematically track symptom emergence. Further, there are no evidence-informed best practices for early identification of CIPN symptoms and grading of severity, nor is there clear information about early time-points for symptom emergence that could inform when clinicians should begin to pay attention to patients' fall risk.

To address this, a team of expert clinicians and researchers from Courage Kenny Rehabilitation Institute (CKRI) and Allina Health Cancer Institute (AHCI) will use a mobile survey system to track the emergence of CIPN symptoms and fall risk over the course of patients' chemotherapy.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 45 years old
  • New cancer diagnosis other than a primary brain tumor
  • A taxane and/or platinum chemotherapy agent has been prescribed as part of the treatment regimen for cancer.
  • English speaking
  • Able to see, hear, speak (with or without assistive devices)
  • Able to walk without an assistive device - for example: cane, walker, walking stick(s) at the start of cancer treatment
  • Able to provide own transportation to study visits
  • Willing and able to commit to symptom tracking three times weekly via mEMA for up to 9 months.
  • Owns a smartphone with one of the following operating system versions:
  • iOS 8.0 - 8.4, 9.0 - 9.3, 10.0 - 10.3, 12, 13.3 or later Android 7.0 - 7.1.2, 8.0 - 8.1.0, 9, 10 or later
  • Agree to use personal smartphone to download the mEMA application and respond to application notifications.

排除标准

  • Individuals who started their chemotherapy regimen greater than 4 weeks prior to study enrollment.
  • Individuals being treated for a primary brain tumor

研究组 & 干预措施

mEMA Arm

Experimental

In this arm, participants will be using a mobile survey system to track the emergence of Chemotherapy-Induced Peripheral Neuropathy symptoms and fall risk over the course of the participant's chemotherapy.

干预措施: Mobile Ecological Momentary Assessment (Behavioral)

结局指标

主要结局

Patient satisfaction with mEMA

时间窗: Through study completion, up to 6 months

Administer a mEMA Experience Survey at each in-person fall-risk assessment to obtain information about participant experience with mEMA over the course of the study.

Patient Adherence to mEMA

时间窗: Through study completion, up to 6 months

Conduct descriptive analyses (mean, mode, median) to determine adherence rates and patterns for mEMA adherence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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