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临床试验/NCT06479005
NCT06479005尚未招募不适用

Early Detection of Clinical Deterioration Using an Integrated Remote Monitoring System in Lung Cancer Patients Receiving Cytotoxic Chemotherapy.

Ziekenhuis Oost-Limburg2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
Time interval

研究概览

简要总结

The primary objective of this project is to determine the feasibility of an integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic chemotherapy.

详细描述

Lung cancer is a highly prevalent malignant tumor with 5.563 new cases in Belgium in 20201. Up to 70% of patients present with locally advanced or metastatic disease at diagnosis 1. Most of these patients require systemic therapy including cytotoxic chemotherapy as part of their treatment plan. The mortality rate in this patient population remains high due to the aggressive nature of the disease, but also due to treatment related toxicities such as dehydration, infection, and anemia, resulting in emergency department (ED) visits and rehospitalizations. Routine administration of highly effective anti-emetics and the use of granulocyte colony-stimulating growth factors greatly reduced the complication rate in these patients 2, 3. Also, remote symptom monitoring using a web-based tool to which patients can self-report their toxicities (i.e., patient-reported outcomes; PROs) had a marked impact on reducing ED visits and increasing overall survival in the patient-reported outcome (PRO) group 4-6. Despite these successes there is still a large proportion of lung cancer patients for whom weekly self-reports are not feasible. More specific: low socio-economic status, elderly patients and social isolation are associated with low compliance 7, 8. The latter lung cancer patient subgroup is at the highest risk of under-detection when presenting with treatment- or disease-related toxicity. The investigators hypothesize that implementation of an integrated remote monitoring system tracking heart rate, heart rate variability, body temperature, respiration rate, nocturnal oxygen saturation, sleep tracking and daily activity level via an unobtrusive wearable device is more performant and less burdensome compared to other self-reporting methods (e.g., PROs). The primary aim of this project is to set up and implement an integrated remote monitoring system in the routine care of lung cancer patients receiving cytotoxic chemotherapy, in which the remote monitoring is enabled via an unobtrusive wearable device. Via this innovative implementation the investigators believe that patient care can be drastically improved due to the earlier detection of deterioration (i.e., less rehospitalizations and ED visits), especially for those high-risk frail patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

open label

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

  • Patient must be in the possession of a phone
  • Diagnosis of Stage IV lung cancer patients treated with cytotoxic chemotherapy
  • Older than 18 years of age

排除标准

  • Life expectancy of less than 6 weeks
  • Not able to understand the Dutch language

结局指标

主要结局

Time interval

时间窗: 18 months

Determining the time interval between clinical deterioration detected by the integrated remote monitoring system and the first contact with the care team (i.e., in current clinical practice the patient suffering from chemotherapy-associated symptoms self-reports at the ED)

Compliance

时间窗: 18 months

Patient compliance in using the integrated remote monitoring system which will be determined via: number of missed measurements, number of telephonic/physical contact moments related to the technology

次要结局

  • mobile Health App Usability Questionnaire to assess usability & acceptability of the remote monitoring system(18 months)
  • System Usability scale to assess usability and acceptability of the remote monitoring system(18 months)
  • Number of ED visits(18 months)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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