Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)

NCT05815472 | Unknown

• 1 other identifier: 3817
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Daily collection of basis real world data such as physical activity in non-small-cell lung cancer patients by portable monitoring systems

  Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as physical activity that will be established on the basis of the number of steps per day. The device will be delivered to patients during the first appointment prior to the beginning of chemotherapy and/or radiotherapy. The collected data will be then transferred to the patient's paired device through the application Healthentia downloaded on appropriate instruments (e.g. smartphone). Data will be collected during multimodal oncological therapies and follow-up period.

  8-52 weeks

• Daily collection of basis real world data such as sleep habits in non-small-cell lung cancer patients by portable monitoring systems

  Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as sleep habits that will be established on the basis of the number of sleeping hours.

  8-52 weeks

• Daily collection of basis real world data such as vital signs in non-small-cell lung cancer patients by portable monitoring systems

  Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as vital signs that will be established on the basis of heartbeats per minute. A normal resting heart rate should be between 60 to 100 beats per minute.

  8-52 weeks

Secondary Outcomes (5)

• The completion of Lawton Instrumental Activities of Daily Living questionnaire

  8-52 weeks

• The completion of the EORTC QLQ-C30 questionnaire

  8-52 weeks

• The completion of the Malnutrition Screening Tool

  8-52 weeks

• The completion of the Distress thermometer - DT6 test

  8-52 weeks

• The completion of Mental Adjustment to Cancer Scale - MINI-MAC 7 questionnaire

  8-52 weeks

Study Arms (1)

Patients affected by locally advanced non-small-cell lung cancer

EXPERIMENTAL

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.

Device: Fitbit charge

Interventions

Fitbit charge DEVICE

Internet of Things Technologies Device

Patients affected by locally advanced non-small-cell lung cancer

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \< 75
• Clinically able to use portable technologies
• Able to understand and sign informed consent

You may not qualify if:

• Major psychiatric disorder
• ECOG\>2 performance status
• Not able to use portable technologies

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Filippo Lococo, Professor

CONTACT

+39 0630156844; filippo.lococo@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 18, 2023
• Study Start: September 28, 2021
• Primary Completion: May 31, 2022
• Study Completion: September 28, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-03

Locations

IT (1)