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NCT Number: NCT06680778

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location status: Recruiting

Location contact

Jason den Duijn, MSc.

CONTACT

[email protected]

+31107040704

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive Monitoring

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. 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)

  2. emergency department visits

    Time frame: Through study completion, an average of 6 months

    Number of emergency department visits

  3. 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

  4. Dose Modification of chemotherapy

    Time frame: Through study completion, an average of 6 months

    Modification in dosage of chemotherapy, documented in electronic patient file

Other outcomes

  1. Age group

    Time frame: Through study completion, an average of 6 months

    Group (18-30, 31-50, 51-65, 65+) of age of participant

  2. Sex

    Time frame: Through study completion, an average of 6 months

    Sex (male/female) of patient

  3. Cancer Type

    Time frame: Through study completion, an average of 6 months

    The cancer diagnosis of the patient

  4. Type of Chemotherapy

    Time frame: Through study completion, an average of 6 months

    The specific chemotherapy a patient will receive

Study contacts

Contact information is provided by the study sponsor or research team.

Jason den Duijn, MSc.

CONTACT

[email protected]

+31107040704

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study 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

Acronym: PROGRESS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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