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

NCT06680778 | Recruiting

• 1 other identifier: 13016
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Emergencies

Keywords

cancer; monitoring; Fitbit

Outcome Measures

Primary Outcomes (10)

• Variance and normalization of resting heart rate

  Variance and normalization of resting heart rate in bpm over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of maximum heart rate

  Variance and normalization of vital parameters maximum heart rate in bpm over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of minimum heart rate

  Variance and normalization of minimum heart rate in bpm over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of heart rate variability

  Variance and normalization of vital parameters heart rate variability over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of respiratory rate

  Variance and normalization of respiratory rate in absolute numbers over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of blood pressure

  Variance and normalization of blood pressure in mmHG over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of step count

  Variance and normalization of step count in absolute numbers over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of blood oxygen saturation

  Variance and normalization of blood oxygen saturation in percentage over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of sleep time

  Variance and normalization of sleep time in hours over time during chemotherapy

  Through study completion, an average of 6 months

• Variance and normalisation of sleep quality

  Variance and normalization of sleep quality on a scale from 1 to 10 over time during chemotherapy

  Through study completion, an average of 6 months

Secondary Outcomes (4)

• 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

Other Outcomes (4)

• Age group

  Through study completion, an average of 6 months

• Sex

  Through study completion, an average of 6 months

• Cancer Type

  Through study completion, an average of 6 months

Study Arms (1)

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.

Device: Proactive Monitoring

Interventions

Proactive Monitoring DEVICE

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

Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitive disorders or severe emotional instability
• Already participating in an exercise trial

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jason den Duijn, MSc.

CONTACT

+31107040704; j.denduijn@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 8, 2024
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)