Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-18
SponsorMurdoch Childrens Research Institute

About this trial

Data collection study to establish a predictive model of infection observed during childhood cancer therapy using data captured by wearable technology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Paediatric, adolescent or young adult diagnosis of cancer AND receiving therapy placing them at risk of infection

Receiving cancer treatment at The Royal Children's Hospital

Patients aged 5-18 years at time of the eligibility screening

If aged < 16 years, parent or guardian able to provide consent

Disqualifiers

<5 years of age.

<16 years of age without guardian or parent consent.

Aged 16-18 and unable to provide consent.

Participant did not consent to wearing Apple Watch for a period of 4 weeks.

Trial population

Patients aged 5-18 years currently receiving treatment for cancer at The Royal Children's Hospital

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Wearable Device

    Device

    Wearable device to collect the following health metrics directly from participants for the duration of the study (4 weeks). Health metrics are collected every 15 minutes, except for the ECG which will be collected once per week. Data points: * ECG data (Once per week) * Exercise time * Body Temperature * Heart Rate * Irregular Heart Rhythm * Blood Oxygen Saturation * Respiratory Rate

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Changes in cardiac electrical activity patterns on Electrocardiogram (ECG)

ECG data will be collected once per week over a 4-week period for each participant to identify changes in cardiac electrical activity that may be associated with early infection. These data will be used as input features for a machine learning model aimed at predicting infection risk in children receiving cancer treatment.

Time frame
Baseline (Day 1), Day 8, Day 15, Day 22, Day 29
2

Changes in physical activity

Exercise data will be collected every 15 minutes over a 4-week period for each participant to identify changes that may correlate with early signs of infection. These data points will be used as input features for a machine learning model aimed at predicting infection risk in children receiving cancer treatment.

Time frame
Baseline (Day 1) and every 15 minutes until Study completion at Day 29
3

Changes in heart rate

Heart rate data will be collected every 15 minutes over a 4-week period for each participant to identify changes that may be indicative of infection. These data points will be used as input features for a machine learning model aimed at predicting infection risk in children receiving cancer treatment.

Time frame
Baseline (Day 1) and every 15 minutes until Study completion at Day 29
4

Changes in heart rhythm

Detection of irregular heart rhythms that may reflect early signs of infection. These data points will be used as input features for a machine learning model aimed at predicting infection risk in children receiving cancer treatment.

Time frame
Baseline (Day 1) and every 15 minutes until Study completion at Day 29

Secondary outcomes

1

The acceptability of using (and not using) wearable devices in children receiving cancer therapies

The acceptability of using wearable devices in children receiving cancer therapies as determined at study completion using the Theoretical Framework of Acceptability (TFA).

Time frame
Day 29

Other outcomes

Sponsors and contacts

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