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Trial Title:
Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
NCT ID:
NCT05815472
Condition:
Non-small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Fitbit charge
Description:
Internet of Things Technologies Device
Arm group label:
Patients affected by locally advanced non-small-cell lung cancer
Summary:
The use of advanced technological tools able to exploit patient-centered "Real World
Data", represents an innovative and fascinating challenge for the most modern
personalized medicine paradigms.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged < 75
- Clinically able to use portable technologies
- Able to understand and sign informed consent
Exclusion Criteria:
- Major psychiatric disorder
- ECOG>2 performance status
- Not able to use portable technologies
Gender:
All
Minimum age:
N/A
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Start date:
September 28, 2021
Completion date:
September 28, 2024
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815472
