CancerPROGRESSNCT06680778
Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch
An observational study of Cancer and Emergencies, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Emergencies
- What is being tested?
- Proactive Monitoring
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive disorders or severe emotional instability
- Already participating in an exercise trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015GD
Jason den Duijn, MSc., +31107040704, j.denduijn@erasmusmc.nl
About this study
Official title: 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.
Read the 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
- Being tested
- Proactive Monitoring
- Keywords
- cancer, monitoring, Fitbit
- Medical subject headings
- Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive MonitoringDevice
Proactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Proactive Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance and normalization of resting heart rate
Variance and normalization of resting heart rate in bpm over time during chemotherapy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
Contact with healthcare provider
Number of contact moments with a healthcare provider (nurse, nurse practioner, general practioner, treating physician)
Measured: Through study completion, an average of 6 months
emergency department visits
Number of emergency department visits
Measured: Through study completion, an average of 6 months
Toxicity
Toxicity, defined as a grade between 1 and 4, documented in electronic patient file
Measured: Through study completion, an average of 6 months
Dose Modification of chemotherapy
Modification in dosage of chemotherapy, documented in electronic patient file
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jul 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason den Duijn, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680778
- Sponsor's protocol ID
- 13016
- Acronym
- PROGRESS
- Status last verified
- Aug 2025
- First submitted
- 14 Oct 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06680778
- Acronym / sponsor ID
- PROGRESS / 13016
- Conditions
- Cancer, Emergencies
- Keywords
- cancer, monitoring, Fitbit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Device: Proactive MonitoringAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive disorders or severe emotional instability
- Already participating in an exercise trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive MonitoringProactive monitoring of vital signs for the duration of the first two cycles of chemotherapy by using a Fitbit | Device | Cancer Patients |
Primary outcome
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
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
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
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
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
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
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
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
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
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
4 secondary outcomes
Contact with healthcare provider
Time frame: Through study completion, an average of 6 months
emergency department visits
Time frame: Through study completion, an average of 6 months
Toxicity
Time frame: Through study completion, an average of 6 months
Dose Modification of chemotherapy
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Emergencies, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason den Duijn, MSc. (+31107040704, j.denduijn@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variance and normalization of resting heart rate (time frame: Through study completion, an average of 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.