Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cognitive disorders or severe emotional instability
Already participating in an exercise trial
Trial population
All patients with stomach and esophageal malignancies referred for chemotherapy of the outpatient clinic at the department of Medical Oncology at the Erasmus University Medical Center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Proactive Monitoring
DeviceProactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit
Treatment groups
175 Participants
are divided into 1 treatment groupGroup A: Cancer Patients1 intervention
Trial outcomes
Primary outcomes
1
Variance and normalization of resting heart rate
Variance and normalization of resting heart rate in bpm over time during chemotherapy
Time frame
Through study completion, an average of 6 months2
Variance and normalisation of maximum heart rate
Variance and normalization of vital parameters maximum heart rate in bpm over time during chemotherapy
Time frame
Through study completion, an average of 6 months3
Variance and normalisation of minimum heart rate
Variance and normalization of minimum heart rate in bpm over time during chemotherapy
Time frame
Through study completion, an average of 6 months4
Variance and normalisation of heart rate variability
Variance and normalization of vital parameters heart rate variability over time during chemotherapy
Time frame
Through study completion, an average of 6 monthsSecondary outcomes
1
Contact with healthcare provider
Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician)
Time frame
Through study completion, an average of 6 months2
emergency department visits
Number of emergency department visits
Time frame
Through study completion, an average of 6 months3
Toxicity
Toxicity, defined as a grade between 1 and 4, documented in electronic patient file
Time frame
Through study completion, an average of 6 months4
Dose Modification of chemotherapy
Modification in dosage of chemotherapy, documented in electronic patient file
Time frame
Through study completion, an average of 6 monthsOther outcomes
1
Age group
Group (18-30, 31-50, 51-65, 65+) of age of participant
Time frame
Through study completion, an average of 6 months2
Sex
Sex (male/female) of patient
Time frame
Through study completion, an average of 6 months3
Cancer Type
The cancer diagnosis of the patient
Time frame
Through study completion, an average of 6 months4
Type of Chemotherapy
The specific chemotherapy a patient will receive
Time frame
Through study completion, an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov