Clinical trial · Observational
Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Emergencies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proactive Monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer Patients
- description
- 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.
- interventionNames
- Device: Proactive Monitoring
Primary outcomes (10)
- measure
- Variance and normalization of resting heart rate
- timeFrame
- Through study completion, an average of 6 months
- description
- Variance and normalization of resting heart rate in bpm over time during chemotherapy
- measure
- Variance and normalisation of maximum heart rate
- timeFrame
- Through study completion, an average of 6 months
- description
- Variance and normalization of vital parameters maximum heart rate in bpm over time during chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available