Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable Device.
- Who it may be relevant to
- Registry conditions: Cancer, Infection, Digital Health, Wearable Devices. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
WEARABLES: Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort
Overview
Data collection study to establish a predictive model of infection observed during childhood cancer therapy using data captured by wearable technology.
Detailed description
Rationale: Development in treatment for childhood cancers has improved remarkably with the 5-year survival rate now exceeding 80% in developed countries. However, these treatments are not without their adverse effects. The international Childhood Cancer Survivor study revealed that 62.3% of survivors had at least one chronic health condition and 27.5% had a severe or life-threatening condition as a direct result of their cancer treatment (DOI: 10.1056/NEJMsa060185). One of the adverse events experienced by 90% of children treated for cancer is infection. Septic shock, the most severe of infection outcomes, is characterized by life-threatening organ dysfunction, is the most and carriers a mortality rate of 41 to 46% (DOI: 10.1016/j.jped.2023.01.001). Beyond mortality, delayed first antibiotic administration (\> 1 hour from fever onset \>38 degrees) is associated with intensive care admissions, prolonged hospital stays, and adverse outcomes. Fluctuations in physiology can precede fever onset by 72 hours in patients with infection. This may provide a window for early detection of infection via wearable technology. The WEARABLES study will combine wearable technology with machine learning to develop an infection prediction model to allow earlier detection and reduce the suffering of children with cancer.
Trial Design: This is a non-interventional silent pilot trial to establish a predictive model for infection observed during childhood cancer therapy using data passively captured via wearables.
The study will be conducted in patients (5-18 years) with a new cancer diagnosis, currently receiving treatment at The Royal Children's Hospital, and have access to an iPhone (either themselves as an adolescent and young adult or via their parents/guardian). Once consented the wearable device will be paired to the patients or parent/guardians phone, and the WEARABLES app will be downloaded onto the phone. Once the device has been set up correctly, the wearable device will collect a range of vital signs for the duration of the study (4 weeks), and a weekly survey will be sent to check for symptoms and/or hospital admissions for infection. At the end of the 4 weeks, participants will receive a final survey to evaluate the feasibility of using a wearable device for toxicity detection. No further involvement will be asked of participants for this pilot trial. All data collected will be utilized to develop a machine learning model for sepsis/infection before being prospectively validated in a second trial.
Interventions
- Device Wearable 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
Primary outcome measures
- Changes in cardiac electrical activity patterns on Electrocardiogram (ECG) [Time frame: Baseline (Day 1), Day 8, Day 15, Day 22, Day 29]
- Changes in physical activity [Time frame: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
- Changes in heart rate [Time frame: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
- Changes in heart rhythm [Time frame: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
- Changes in blood oxygen saturation [Time frame: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
- Changes in respiratory rate [Time frame: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
- Infection-Related Hospital Admission [Time frame: Baseline (Day 1), Day 8, Day 15, Day 22, Day 29]
Secondary outcome measures (1)
- The acceptability of using (and not using) wearable devices in children receiving cancer therapies [Time frame: Day 29]
Eligibility criteria
Inclusion criteria
- 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
- iPhone 8 or later (iOS must be up to date/updated at time of enrolment)
- At least 10MB of iPhone storage for WEARABLES app and data collection.
- Willing and able to wear a wearable device for a period of 4 weeks (during waking hours).
- Consent to data being shared to the WEARABLES app (owned by the research team).
Exclusion criteria
- <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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Australia · 1 center
- The Royal Children's Hospital — Parkville
Identifiers
NCT: NCT07030998 · 111206