Clinical trial NCT06680778: Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Emergencies
Keywords: cancer
monitoring
Fitbit
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Variance and normalization of resting heart rate
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of maximum heart rate
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of minimum heart rate
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of heart rate variability
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of respiratory rate
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of blood pressure
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of step count
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of blood oxygen saturation
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of sleep time
timeFrame: Through study completion, an average of 6 months
measure: Variance and normalisation of sleep quality
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Contact with healthcare provider
timeFrame: Through study completion, an average of 6 months
measure: emergency department visits
timeFrame: Through study completion, an average of 6 months
measure: Toxicity
timeFrame: Through study completion, an average of 6 months
measure: Dose Modification of chemotherapy
timeFrame: Through study completion, an average of 6 months
Other outcomes:
measure: Age group
timeFrame: Through study completion, an average of 6 months
measure: Sex
timeFrame: Through study completion, an average of 6 months
measure: Cancer Type
timeFrame: Through study completion, an average of 6 months
measure: Type of Chemotherapy
timeFrame: Through study completion, an average of 6 months
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
Study officials:
References: