Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Brief Title:
ETERNALS Remote Monitoring in Lung Cancer Patients
Sponsor:
Ziekenhuis Oost-Limburg
Organization:
Ziekenhuis Oost-Limburg
Study Overview
Official Title:
Early Detection of Clinical Deterioration Using an Integrated Remote Monitoring System in Lung Cancer Patients Receiving Cytotoxic Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETERNALS
Brief Summary:
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
Detailed Description:
Lung cancer is a highly prevalent malignant tumor with 5563 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 ie 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 eg 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 ie less rehospitalizations and ED visits especially for those high-risk frail patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None