ETERNALS: Remote Monitoring in Lung Cancer Patients
ETERNALS
Early Detection of Clinical Deterioration Using an Integrated Remote Monitoring System in Lung Cancer Patients Receiving Cytotoxic Chemotherapy.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable nonsmall-cell-lung-cancer
Started Jul 2024
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 1, 2024
May 1, 2024
1.2 years
June 12, 2024
June 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Time interval
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)
18 months
Compliance
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
18 months
Secondary Outcomes (3)
System Usability scale to assess usability and acceptability of the remote monitoring system
18 months
mobile Health App Usability Questionnaire to assess usability & acceptability of the remote monitoring system
18 months
Number of ED visits
18 months
Study Arms (1)
interventional feasibility study arm
EXPERIMENTALPatients will receive a wearable device to monitor vital parameters continuously from the first round of chemo until the last cycle (approx 15 weeks).
Interventions
The Oura ring will remotely monitor the patients vitals at home continuously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Life expectancy of less than 6 weeks
- Not able to understand the Dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten Criel, MD, PhD
Ziekenhuis Oost-Limburg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- open label
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 27, 2024
Study Start
July 1, 2024
Primary Completion
September 30, 2025
Study Completion
December 31, 2025
Last Updated
July 1, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share