Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
NCT ID: NCT05815472
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-09-28
2024-09-28
Brief Summary
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Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction.
The big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (A.I.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients.
Primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices.
More specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed.
The machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices.
This is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients affected by locally advanced non-small-cell lung cancer
Patients affected by locally advanced non-small-cell lung cancer (staged III according to 8th TNM classification), undergoing induction therapy (IT) followed by either radical surgery or immunotherapy boost and treated in Fondazione Policlinico Universitario "A. Gemelli" IRCCS of Rome, Italy, will be enrolled in this study.
Fitbit charge
Internet of Things Technologies Device
Interventions
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Fitbit charge
Internet of Things Technologies Device
Eligibility Criteria
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Inclusion Criteria
* Clinically able to use portable technologies
* Able to understand and sign informed consent
Exclusion Criteria
* ECOG\>2 performance status
* Not able to use portable technologies
75 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Countries
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Central Contacts
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Other Identifiers
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3817
Identifier Type: -
Identifier Source: org_study_id
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