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Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study

BACKGROUND: Timely recognition of cancer progression and treatment complications is important for treatment guidance. Digital phenotyping is a promising method for precise and remote monitoring of patients in their natural environments by using passively generated data from sensors of personal weara...

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Autores principales: Jenciūtė, Gabrielė, Kasputytė, Gabrielė, Bunevičienė, Inesa, Korobeinikova, Erika, Vaitiekus, Domas, Inčiūra, Arturas, Jaruševičius, Laimonas, Bunevičius, Romas, Krikštolaitis, Ričardas, Krilavičius, Tomas, Juozaitytė, Elona, Bunevičius, Adomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599285/
https://www.ncbi.nlm.nih.gov/pubmed/37815850
http://dx.doi.org/10.2196/49096
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author Jenciūtė, Gabrielė
Kasputytė, Gabrielė
Bunevičienė, Inesa
Korobeinikova, Erika
Vaitiekus, Domas
Inčiūra, Arturas
Jaruševičius, Laimonas
Bunevičius, Romas
Krikštolaitis, Ričardas
Krilavičius, Tomas
Juozaitytė, Elona
Bunevičius, Adomas
author_facet Jenciūtė, Gabrielė
Kasputytė, Gabrielė
Bunevičienė, Inesa
Korobeinikova, Erika
Vaitiekus, Domas
Inčiūra, Arturas
Jaruševičius, Laimonas
Bunevičius, Romas
Krikštolaitis, Ričardas
Krilavičius, Tomas
Juozaitytė, Elona
Bunevičius, Adomas
author_sort Jenciūtė, Gabrielė
collection PubMed
description BACKGROUND: Timely recognition of cancer progression and treatment complications is important for treatment guidance. Digital phenotyping is a promising method for precise and remote monitoring of patients in their natural environments by using passively generated data from sensors of personal wearable devices. Further studies are needed to better understand the potential clinical benefits of digital phenotyping approaches to optimize care of patients with cancer. OBJECTIVE: We aim to evaluate whether passively generated data from smartphone sensors are feasible for remote monitoring of patients with cancer to predict their disease trajectories and patient-centered health outcomes. METHODS: We will recruit 200 patients undergoing treatment for cancer. Patients will be followed up for 6 months. Passively generated data by sensors of personal smartphone devices (eg, accelerometer, gyroscope, GPS) will be continuously collected using the developed LAIMA smartphone app during follow-up. We will evaluate (1) mobility data by using an accelerometer (mean time of active period, mean time of exertional physical activity, distance covered per day, duration of inactive period), GPS (places of interest visited daily, hospital visits), and gyroscope sensors and (2) sociability indices (frequency of duration of phone calls, frequency and length of text messages, and internet browsing time). Every 2 weeks, patients will be asked to complete questionnaires pertaining to quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30]), depression symptoms (Patient Health Questionnaire-9 [PHQ-9]), and anxiety symptoms (General Anxiety Disorder-7 [GAD-7]) that will be deployed via the LAIMA app. Clinic visits will take place at 1-3 months and 3-6 months of the study. Patients will be evaluated for disease progression, cancer and treatment complications, and functional status (Eastern Cooperative Oncology Group) by the study oncologist and will complete the questionnaire for evaluating quality of life (EORTC QLQ-C30), depression symptoms (PHQ-9), and anxiety symptoms (GAD-7). We will examine the associations among digital, clinical, and patient-reported health outcomes to develop prediction models with clinically meaningful outcomes. RESULTS: As of July 2023, we have reached the planned recruitment target, and patients are undergoing follow-up. Data collection is expected to be completed by September 2023. The final results should be available within 6 months after study completion. CONCLUSIONS: This study will provide in-depth insight into temporally and spatially precise trajectories of patients with cancer that will provide a novel digital health approach and will inform the design of future interventional clinical trials in oncology. Our findings will allow a better understanding of the potential clinical value of passively generated smartphone sensor data (digital phenotyping) for continuous and real-time monitoring of patients with cancer for treatment side effects, cancer complications, functional status, and patient-reported outcomes as well as prediction of disease progression or trajectories. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49096
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spelling pubmed-105992852023-10-26 Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study Jenciūtė, Gabrielė Kasputytė, Gabrielė Bunevičienė, Inesa Korobeinikova, Erika Vaitiekus, Domas Inčiūra, Arturas Jaruševičius, Laimonas Bunevičius, Romas Krikštolaitis, Ričardas Krilavičius, Tomas Juozaitytė, Elona Bunevičius, Adomas JMIR Res Protoc Protocol BACKGROUND: Timely recognition of cancer progression and treatment complications is important for treatment guidance. Digital phenotyping is a promising method for precise and remote monitoring of patients in their natural environments by using passively generated data from sensors of personal wearable devices. Further studies are needed to better understand the potential clinical benefits of digital phenotyping approaches to optimize care of patients with cancer. OBJECTIVE: We aim to evaluate whether passively generated data from smartphone sensors are feasible for remote monitoring of patients with cancer to predict their disease trajectories and patient-centered health outcomes. METHODS: We will recruit 200 patients undergoing treatment for cancer. Patients will be followed up for 6 months. Passively generated data by sensors of personal smartphone devices (eg, accelerometer, gyroscope, GPS) will be continuously collected using the developed LAIMA smartphone app during follow-up. We will evaluate (1) mobility data by using an accelerometer (mean time of active period, mean time of exertional physical activity, distance covered per day, duration of inactive period), GPS (places of interest visited daily, hospital visits), and gyroscope sensors and (2) sociability indices (frequency of duration of phone calls, frequency and length of text messages, and internet browsing time). Every 2 weeks, patients will be asked to complete questionnaires pertaining to quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30]), depression symptoms (Patient Health Questionnaire-9 [PHQ-9]), and anxiety symptoms (General Anxiety Disorder-7 [GAD-7]) that will be deployed via the LAIMA app. Clinic visits will take place at 1-3 months and 3-6 months of the study. Patients will be evaluated for disease progression, cancer and treatment complications, and functional status (Eastern Cooperative Oncology Group) by the study oncologist and will complete the questionnaire for evaluating quality of life (EORTC QLQ-C30), depression symptoms (PHQ-9), and anxiety symptoms (GAD-7). We will examine the associations among digital, clinical, and patient-reported health outcomes to develop prediction models with clinically meaningful outcomes. RESULTS: As of July 2023, we have reached the planned recruitment target, and patients are undergoing follow-up. Data collection is expected to be completed by September 2023. The final results should be available within 6 months after study completion. CONCLUSIONS: This study will provide in-depth insight into temporally and spatially precise trajectories of patients with cancer that will provide a novel digital health approach and will inform the design of future interventional clinical trials in oncology. Our findings will allow a better understanding of the potential clinical value of passively generated smartphone sensor data (digital phenotyping) for continuous and real-time monitoring of patients with cancer for treatment side effects, cancer complications, functional status, and patient-reported outcomes as well as prediction of disease progression or trajectories. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49096 JMIR Publications 2023-10-10 /pmc/articles/PMC10599285/ /pubmed/37815850 http://dx.doi.org/10.2196/49096 Text en ©Gabrielė Jenciūtė, Gabrielė Kasputytė, Inesa Bunevičienė, Erika Korobeinikova, Domas Vaitiekus, Arturas Inčiūra, Laimonas Jaruševičius, Romas Bunevičius, Ričardas Krikštolaitis, Tomas Krilavičius, Elona Juozaitytė, Adomas Bunevičius. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.10.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Jenciūtė, Gabrielė
Kasputytė, Gabrielė
Bunevičienė, Inesa
Korobeinikova, Erika
Vaitiekus, Domas
Inčiūra, Arturas
Jaruševičius, Laimonas
Bunevičius, Romas
Krikštolaitis, Ričardas
Krilavičius, Tomas
Juozaitytė, Elona
Bunevičius, Adomas
Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title_full Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title_fullStr Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title_full_unstemmed Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title_short Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study
title_sort digital phenotyping for monitoring and disease trajectory prediction of patients with cancer: protocol for a prospective observational cohort study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599285/
https://www.ncbi.nlm.nih.gov/pubmed/37815850
http://dx.doi.org/10.2196/49096
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