Идёт набор NCT06680778

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

— Наблюдательное Cancer Emergencies

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: Proactive Monitoring.
Кому может быть актуально: Состояния в реестре: Cancer, Emergencies. Базовые параметры: от 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: Нидерланды
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

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

Обзор

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Variance and normalization of resting heart rate [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of maximum heart rate [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of minimum heart rate [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of heart rate variability [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of respiratory rate [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of blood pressure [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of step count [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of blood oxygen saturation [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of sleep time [Срок оценки: Through study completion, an average of 6 months]
Variance and normalisation of sleep quality [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (4)

Contact with healthcare provider [Срок оценки: Through study completion, an average of 6 months]
emergency department visits [Срок оценки: Through study completion, an average of 6 months]
Toxicity [Срок оценки: Through study completion, an average of 6 months]
Dose Modification of chemotherapy [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

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