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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Monitoring | Device | Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variance and normalization of resting heart rate | Variance and normalization of resting heart rate in bpm over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of maximum heart rate | Variance and normalization of vital parameters maximum heart rate in bpm over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of minimum heart rate | Variance and normalization of minimum heart rate in bpm over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of heart rate variability | Variance and normalization of vital parameters heart rate variability over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of respiratory rate | Variance and normalization of respiratory rate in absolute numbers over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of blood pressure | Variance and normalization of blood pressure in mmHG over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of step count | Variance and normalization of step count in absolute numbers over time during chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Contact with healthcare provider | Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician) | Through study completion, an average of 6 months |
| emergency department visits |
| Measure | Description | Time Frame |
|---|---|---|
| Age group | Group (18-30, 31-50, 51-65, 65+) of age of participant | Through study completion, an average of 6 months |
| Sex | Sex (male/female) of patient |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason den Duijn, MSc. | Contact | +31107040704 | j.denduijn@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Through study completion, an average of 6 months |
| Variance and normalisation of blood oxygen saturation | Variance and normalization of blood oxygen saturation in percentage over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of sleep time | Variance and normalization of sleep time in hours over time during chemotherapy | Through study completion, an average of 6 months |
| Variance and normalisation of sleep quality | Variance and normalization of sleep quality on a scale from 1 to 10 over time during chemotherapy | Through study completion, an average of 6 months |
Number of emergency department visits
| Through study completion, an average of 6 months |
| Toxicity | Toxicity, defined as a grade between 1 and 4, documented in electronic patient file | Through study completion, an average of 6 months |
| Dose Modification of chemotherapy | Modification in dosage of chemotherapy, documented in electronic patient file | Through study completion, an average of 6 months |
| Through study completion, an average of 6 months |
| Cancer Type | The cancer diagnosis of the patient | Through study completion, an average of 6 months |
| Type of Chemotherapy | The specific chemotherapy a patient will receive | Through study completion, an average of 6 months |