Non-small-cell Lung CancerAPALITTNCT05815472
Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
A study testing Fitbit charge in people with Non-small-cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Fitbit charge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2021to 28 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged < 75
- Clinically able to use portable technologies
- Able to understand and sign informed consent
Who cannot join
- Major psychiatric disorder
- ECOG>2 performance status
- Not able to use portable technologies
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
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.
Read more
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
- Being tested
- Fitbit charge
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit chargeDevice
Internet of Things Technologies Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitbit charge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8-52 weeks
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8-52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start28 Sep 2021
- Primary completion31 May 2022
- Study completion28 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815472
- Sponsor's protocol ID
- 3817
- Acronym
- APALITT
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
- ClinicalTrials.gov ID
- NCT05815472
- Acronym / sponsor ID
- APALITT / 3817
- Conditions
- Non-small-cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 28 Sep 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by locally advanced non-small-cell lung cancer | Experimental | Device: Fitbit chargePatients 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. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged < 75
- Clinically able to use portable technologies
- Able to understand and sign informed consent
Key exclusion criteria (3 listed)
- Major psychiatric disorder
- ECOG>2 performance status
- Not able to use portable technologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit chargeInternet of Things Technologies Device | Device | Patients affected by locally advanced non-small-cell lung cancer |
Primary outcome
Daily collection of basis real world data such as physical activity in non-small-cell lung cancer patients by portable monitoring systems
Time frame: 8-52 weeks
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.
Daily collection of basis real world data such as sleep habits in non-small-cell lung cancer patients by portable monitoring systems
Time frame: 8-52 weeks
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.
Daily collection of basis real world data such as vital signs in non-small-cell lung cancer patients by portable monitoring systems
Time frame: 8-52 weeks
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.
5 secondary outcomes
The completion of Lawton Instrumental Activities of Daily Living questionnaire
Time frame: 8-52 weeks
The completion of the EORTC QLQ-C30 questionnaire
Time frame: 8-52 weeks
The completion of the Malnutrition Screening Tool
Time frame: 8-52 weeks
The completion of the Distress thermometer - DT6 test
Time frame: 8-52 weeks
The completion of Mental Adjustment to Cancer Scale - MINI-MAC 7 questionnaire
Time frame: 8-52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit charge in people with Non-small-cell Lung Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filippo Lococo, Professor (+39 0630156844, filippo.lococo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily collection of basis real world data such as physical activity in non-small-cell lung cancer patients by portable monitoring systems (time frame: 8-52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.