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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Erasmus Medical Center
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Variance and normalization of resting heart rate
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Jason den Duijn
Principal Investigator
Erasmus Medical Center
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
Outcomes
Primary Outcomes
Variance and normalization of resting heart rate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Contact with healthcare provider(Through study completion, an average of 6 months)
- emergency department visits(Through study completion, an average of 6 months)
- Toxicity(Through study completion, an average of 6 months)
- Dose Modification of chemotherapy(Through study completion, an average of 6 months)