An interventional study of Oura Ring in Non-small Cell Lung Cancer, Remote Monitoring and Mobile Health, sponsored by Ziekenhuis Oost-Limburg. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic
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.
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.
6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 50 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 17 are open to participants now.
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Inclusion Criteria:-
Exclusion Criteria:
Patients will receive a wearable device to monitor vital parameters continuously from the first round of chemo until the last cycle (approx 15 weeks).
Device: Oura Ring
The Oura ring will remotely monitor the patients vitals at home continuously
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)
Time frame: 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
Time frame: 18 months
System Usability scale to assess usability and acceptability of the remote monitoring system
Acceptability and usability of the integrated remote monitoring system by both the patient and the healthcare specialists. This will be assessed using the following questionnaire: System Usability scale (SUS). The scale varies from 1-5, corresponding with 1 being strongly disagree and 5 strongly agree. Depending on the question, the score can be found either positive/negative.
Time frame: 18 months
mobile Health App Usability Questionnaire to assess usability & acceptability of the remote monitoring system
Acceptability and usability of the integrated remote monitoring system by both the Acceptability and usability of the integrated remote monitoring system by both the patient and the healthcare specialists. This will be assessed using the following questionnaire: mobile Health App Usability Questionnaire (MAUQ). The scale varies from 1-7, with 1 corresponding to 'disagree' and 7 corresponding to 'agree'. Depending on the question, the score can be found either positive/negative.
Time frame: 18 months
Number of ED visits
Determine the number of ED visits retrospectively, including the disease- and therapy related/induced complications (retrospective sub-study)
Time frame: 18 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Carcinoma, Non-Small-Cell Lung →
Ziekenhuis Oost-Limburg