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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergencies; Cancer
• Intervention / Treatment: Device: Proactive Monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: Jason den Duijn, MSc.; Phone Number: +31107040704; Email: j.denduijn@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus University Medical Center
      • Contact: Jason den Duijn, MSc.; Phone Number: +31107040704; Email: j.denduijn@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact with healthcare provider	Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician)	Through study completion, an average of 6 months
emergency department visits	Number of emergency department visits	Through study completion, an average of 6 months
Toxicity	Toxicity, defined as a grade between 1 and 4, documented in electronic patient file	Through study completion, an average of 6 months
Dose Modification of chemotherapy	Modification in dosage of chemotherapy, documented in electronic patient file	Through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age group	Group (18-30, 31-50, 51-65, 65+) of age of participant	Through study completion, an average of 6 months
Sex	Sex (male/female) of patient	Through study completion, an average of 6 months
Cancer Type	The cancer diagnosis of the patient	Through study completion, an average of 6 months
Type of Chemotherapy	The specific chemotherapy a patient will receive	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: cancer; Fitbit; monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 13016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No