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临床试验/NCT05235594
NCT05235594已完成不适用

Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period

研究概览

简要总结

The study will assess the feasibility of using the ChronolifeTM smart t-shirt for home monitoring of vital parameters in cancer patients during their treatment course. This study will bring new insights to how wearables and biometric data can be used as a part of symptom recognition in cancer patients during treatment course in the quest of increasing patients' quality of life.

详细描述

Collecting biometric sensor data by wearables is an example of real-time patient-generated health data that can provide vital and detailed objective information about patients. This may have the potential to improve quality of oncological treatment and increase patients' quality of life.

Studies have shown that there may be a dissimilar perception on symptoms and side effects between patients and health care professionals. Wearables may help identifying symptoms earlier.

A new design of a wearable is a smart t-shirt. A smart t-shirt has sensors embedded in the fabric which generate measurement flows. This new tool provide more precise information without recall and reporting bias which may have the potential to lead to a better and more accurate cancer treatment.

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

入选标准

  • Danish cancer patients ≥18 years in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark
  • Both patients in curative and palliative care will be eligible
  • 10 cancer patients under 39 years
  • 10 cancer patients over 65 years
  • Able to read and speak Danish

排除标准

  • Serious cognitive deficits

结局指标

主要结局

Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period

时间窗: 2 weeks

To assess the feasibility of using the ChronolifeTM smart t-shirt based on the completion rate which is defined as the number of included patients using the smart t-shirt at least 12 hours pr. day during the three weeks study period.

次要结局

  • Technical feasibility(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helle Pappot

Professor, MD

Rigshospitalet, Denmark

研究点 (2)

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