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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2024-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small-cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Fitbit charge

Intervention Type DEVICE

Internet of Things Technologies Device

Interventions

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Fitbit charge

Internet of Things Technologies Device

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Filippo Lococo, Professor

Role: CONTACT

+39 0630156844

Other Identifiers

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3817

Identifier Type: -

Identifier Source: org_study_id

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