Cancer, Emergencies
Conditions
Keywords
cancer, monitoring, Fitbit
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.
Interventions
DEVICEProactive Monitoring
Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Age group | Through study completion, an average of 6 months | Group (18-30, 31-50, 51-65, 65+) of age of participant |
| Cancer Type | Through study completion, an average of 6 months | The cancer diagnosis of the patient |
| Type of Chemotherapy | Through study completion, an average of 6 months | The specific chemotherapy a patient will receive |
| Sex | Through study completion, an average of 6 months | Sex (male/female) of patient |
Countries
Netherlands
Contacts
Primary ContactJason den Duijn, MSc.
Outcome results
None listed