Recruiting NCT06680778

Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch

— Observational Cancer Emergencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Proactive Monitoring.
Who it may be relevant to: Registry conditions: Cancer, Emergencies. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Netherlands
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Use of Proa-active Monitoring by Measuring Vital Signs Using a Fitbit for a 3-month Period Before, During, and After Chemotherapy in Patients With Cancer

Overview

Detailed description

The goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. The main question it aims to answer are: Can changes in vital parameters be measured by using a Fitbit in patients with cancer while undergoing chemotherapy. Participants will be asked to wear a Fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters. Patients will start measuring in the week prior to the first cycle of chemotherapy, target is at least 4 to 7 days before initiation of chemotherapy. Patients were the Fitbit as much as possible, during day and night. Patients continuously carry the Fitbit during the first 3 months of systemic treatment, which tracks their vital signs. At the starting day of the next cycle of chemotherapy patients will have an appointment with one of the researchers to evaluate the use of the Fitbit. Furthermore, it will be checked if a patient has returned to their baseline vital signs.

Interventions

Device Proactive Monitoring
Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit

Primary outcome measures

Variance and normalization of resting heart rate [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of maximum heart rate [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of minimum heart rate [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of heart rate variability [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of respiratory rate [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of blood pressure [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of step count [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of blood oxygen saturation [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of sleep time [Time frame: Through study completion, an average of 6 months]
Variance and normalisation of sleep quality [Time frame: Through study completion, an average of 6 months]

Secondary outcome measures (4)

Contact with healthcare provider [Time frame: Through study completion, an average of 6 months]
emergency department visits [Time frame: Through study completion, an average of 6 months]
Toxicity [Time frame: Through study completion, an average of 6 months]
Dose Modification of chemotherapy [Time frame: Through study completion, an average of 6 months]

Eligibility criteria

Inclusion criteria

Age ≥18 years;
Diagnosis of stomach or esophageal cancer with an indication of starting chemotherapy
Knowledge how to handle a Fitbit
Mastery of Dutch language
Able and willing to give written informed consent

Exclusion criteria

Cognitive disorders or severe emotional instability
Already participating in an exercise trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Netherlands · 1 center

Erasmus University Medical Center — Rotterdam

Identifiers

NCT: NCT06680778 · 13016

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗