Erasmus University Medical Center
Rotterdam, South Holland, 3015GD, Netherlands
Location status: Recruiting
NCT Number: NCT06680778
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rotterdam, South Holland, 3015GD, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit
Time frame: Through study completion, an average of 6 months
Variance and normalization of resting heart rate in bpm over time during chemotherapy
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
Time frame: Through study completion, an average of 6 months
Variance and normalization of minimum heart rate in bpm over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of vital parameters heart rate variability over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of respiratory rate in absolute numbers over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of blood pressure in mmHG over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of step count in absolute numbers over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of blood oxygen saturation in percentage over time during chemotherapy
Time frame: Through study completion, an average of 6 months
Variance and normalization of sleep time in hours over time during chemotherapy
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
Time frame: Through study completion, an average of 6 months
Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician)
Time frame: Through study completion, an average of 6 months
Number of emergency department visits
Time frame: Through study completion, an average of 6 months
Toxicity, defined as a grade between 1 and 4, documented in electronic patient file
Time frame: Through study completion, an average of 6 months
Modification in dosage of chemotherapy, documented in electronic patient file
Time frame: Through study completion, an average of 6 months
Group (18-30, 31-50, 51-65, 65+) of age of participant
Time frame: Through study completion, an average of 6 months
Sex (male/female) of patient
Time frame: Through study completion, an average of 6 months
The cancer diagnosis of the patient
Time frame: Through study completion, an average of 6 months
The specific chemotherapy a patient will receive
Contact information is provided by the study sponsor or research team.
Erasmus Medical Center
Other
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
Acronym: PROGRESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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