Идёт набор NCT07030998

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

— Наблюдательное Cancer Infection Digital Health Wearable Devices

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Wearable Device.
Кому может быть актуально: Состояния в реестре: Cancer, Infection, Digital Health, Wearable Devices. Базовые параметры: 5 лет — 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

Устройство 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

Первичные конечные точки

Changes in cardiac electrical activity patterns on Electrocardiogram (ECG) [Срок оценки: Baseline (Day 1), Day 8, Day 15, Day 22, Day 29]
Changes in physical activity [Срок оценки: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
Changes in heart rate [Срок оценки: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
Changes in heart rhythm [Срок оценки: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
Changes in blood oxygen saturation [Срок оценки: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
Changes in respiratory rate [Срок оценки: Baseline (Day 1) and every 15 minutes until Study completion at Day 29]
Infection-Related Hospital Admission [Срок оценки: Baseline (Day 1), Day 8, Day 15, Day 22, Day 29]

Вторичные конечные точки (1)

The acceptability of using (and not using) wearable devices in children receiving cancer therapies [Срок оценки: Day 29]

Критерии участия

Критерии включения

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).