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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small-cell Lung Cancer
• Intervention / Treatment: Device: Fitbit charge

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Filippo Lococo, Professor; Phone Number: +39 0630156844; Email: filippo.lococo@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Fitbit charge; Internet of Things Technologies Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completion of Lawton Instrumental Activities of Daily Living questionnaire	During the whole observation period, patients will be also asked to report their independent living skills through the same application, completing the dedicated questionnaire with the following scoring systems. The Lawton Instrumental Activities of Daily Living (IADL) will be evaluated using the Lawton Brody instrumental scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and from 0 to 5 for men (8-items version).	8-52 weeks
The completion of the EORTC QLQ-C30 questionnaire	During the whole observation period, patients will be also asked to report their Quality of Life through the same application, completing the dedicated questionnaire with the following scoring systems. The EORTC QLQ-C30 questionnaire comprises 30 items, 24 of which are combined into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnea, sleep disorders, appetite loss, diarrhea, constipation, and the financial impact) scales assess symptoms. All of the scales and single-item measures range in score from 0 to 100. Higher score for global health status and functioning scales indicates a better level of functioning, whereas higher scores on symptom-oriented scales means more severe symptoms.	8-52 weeks
The completion of the Malnutrition Screening Tool	During the whole observation period, patients will be also asked to report their nutritional status through the same application, completing the dedicated questionnaire with the following scoring systems. The Malnutrition Screening Tool is an easy two question screening tool that evaluates the level of malnutrition risk, giving a score out of five. To calculate the total score, add the point(s) from question one and question two together to get a total.; A score of 0 - 1 indicates a low risk of malnutrition.; A score of 2 indicates a moderate risk of malnutrition.; A score of 3 - 5 indicates a high risk of malnutrition.	8-52 weeks
The completion of the Distress thermometer - DT6 test	During the whole observation period, patients will be also asked to report their psychological status through the same application, completing the dedicated questionnaire with the following scoring systems. The distress thermometer (DT) is an efficient tool for identifying distress among cancer patients worldwide. The National Comprehensive Cancer network (NCCN) Distress Thermometer (DT) is a one-item, 11-point Likert scale depicted as a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.	8-52 weeks
The completion of Mental Adjustment to Cancer Scale - MINI-MAC 7 questionnaire	During the whole observation period, patients will be also asked to report their psychological status through the same application, completing the dedicated questionnaire with the following scoring systems. The Mental Adjustment to Cancer Scale - MINI-MAC 7, Italian version, consists of 29 statements, which aim at measuring four ways of facing cancer, such as Anxiety, Fighting spirit, Helplessness-hopelessness, and Positive reevaluation. Each statement is rated on a scale of 1 (definitely not) to 4 (definitely yes). According to the answers, each of the four ways of dealing with the disease will be rated from 7 to 28 points. The higher the score, the greater the severity of the behaviors in the patient's struggle with cancer.	8-52 weeks

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Anticipated): September 28, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 3817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No