Clinical trial NCT06479005: ETERNALS: Remote Monitoring in Lung Cancer Patients
Official title: Early Detection of Clinical Deterioration Using an Integrated Remote Monitoring System in Lung Cancer Patients Receiving Cytotoxic Chemotherapy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Remote Monitoring
Mobile Health
Chemotherapy Effect
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric prospective interventional feasibility study
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: Inclusion Criteria:-

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Time interval
timeFrame: 18 months
measure: Compliance
timeFrame: 18 months
Secondary outcomes:
measure: System Usability scale to assess usability and acceptability of the remote monitoring system
timeFrame: 18 months
measure: mobile Health App Usability Questionnaire to assess usability & acceptability of the remote monitoring system
timeFrame: 18 months
measure: Number of ED visits
timeFrame: 18 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Maarten Criel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: