Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch

NCT ID: NCT06680778

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Cancer; Emergencies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer Patients

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.

Proactive Monitoring

Intervention Type: DEVICE

Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit

Interventions

Proactive Monitoring

Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason den Duijn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jason den Duijn, MSc.

Role: CONTACT

j.denduijn@erasmusmc.nl

+31107040704

Facility Contacts

Jason den Duijn, MSc.

Role: primary

j.denduijn@erasmusmc.nl

+31107040704

Other Identifiers

13016

Identifier Type: -

Identifier Source: org_study_id