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

August 12, 2025 updated by: Jason den Duijn, Erasmus Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variance and normalization of resting heart rate
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contact with healthcare provider
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
Number of emergency department visits
Through study completion, an average of 6 months
Toxicity
Time Frame: Through study completion, an average of 6 months
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
Time Frame: Through study completion, an average of 6 months
Modification in dosage of chemotherapy, documented in electronic patient file
Through study completion, an average of 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age group
Time Frame: Through study completion, an average of 6 months
Group (18-30, 31-50, 51-65, 65+) of age of participant
Through study completion, an average of 6 months
Sex
Time Frame: Through study completion, an average of 6 months
Sex (male/female) of patient
Through study completion, an average of 6 months
Cancer Type
Time Frame: Through study completion, an average of 6 months
The cancer diagnosis of the patient
Through study completion, an average of 6 months
Type of Chemotherapy
Time Frame: Through study completion, an average of 6 months
The specific chemotherapy a patient will receive
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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