Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch
- Conditions
- CancerEmergencies
- Registration Number
- NCT06680778
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 175
- 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
- Cognitive disorders or severe emotional instability
- Already participating in an exercise trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variance and normalization of resting heart rate Through study completion, an average of 6 months Variance and normalization of resting heart rate in bpm over time during chemotherapy
Variance and normalisation of maximum heart rate Through study completion, an average of 6 months Variance and normalization of vital parameters maximum heart rate in bpm over time during chemotherapy
Variance and normalisation of minimum heart rate Through study completion, an average of 6 months Variance and normalization of minimum heart rate in bpm over time during chemotherapy
Variance and normalisation of heart rate variability Through study completion, an average of 6 months Variance and normalization of vital parameters heart rate variability over time during chemotherapy
Variance and normalisation of respiratory rate Through study completion, an average of 6 months Variance and normalization of respiratory rate in absolute numbers over time during chemotherapy
Variance and normalisation of blood pressure Through study completion, an average of 6 months Variance and normalization of blood pressure in mmHG over time during chemotherapy
Variance and normalisation of step count Through study completion, an average of 6 months Variance and normalization of step count in absolute numbers over time during chemotherapy
Variance and normalisation of blood oxygen saturation Through study completion, an average of 6 months Variance and normalization of blood oxygen saturation in percentage over time during chemotherapy
Variance and normalisation of sleep time Through study completion, an average of 6 months Variance and normalization of sleep time in hours over time during chemotherapy
Variance and normalisation of sleep quality Through study completion, an average of 6 months Variance and normalization of sleep quality on a scale from 1 to 10 over time during chemotherapy
- Secondary Outcome Measures
Name Time Method Contact with healthcare provider Through study completion, an average of 6 months Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician)
emergency department visits Through study completion, an average of 6 months Number of emergency department visits
Toxicity Through study completion, an average of 6 months Toxicity, defined as a grade between 1 and 4, documented in electronic patient file
Dose Modification of chemotherapy Through study completion, an average of 6 months Modification in dosage of chemotherapy, documented in electronic patient file
Trial Locations
- Locations (1)
Erasmus University Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands