Pain ASsessment in CAncer Patients by Machine LEarning (PASCALE)

Sponsor
National Cancer Institute, Naples (Other)
Overall Status
Recruiting
CT.gov ID
NCT04726228
Collaborator
Federico II University (Other)
40
Enrollment
2
Locations
47.3
Anticipated Duration (Months)
20
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In cancer patients, the integration between anticancer therapies and palliative care is of fundamental importance. In this context, telemedicine can improve the quality of life (QoL) of chronic patients through self-management and remote monitoring solutions. This approach can favor the effectiveness of the treatment and therapeutic adherence. Of note, telemedicine can also be applied to the management of cancer pain. In the advanced stages of cancer disease, pain is one of the most obvious and most disabling symptoms. Consequently, proper pain management has a significant impact on the QoL, the ability to withstand treatment, and the recovery of patients. On the other hand, given the complexity of cancer pain, the main obstacle to its proper management is the lack of adequate measurement methods. Although in recent years a great deal of effort has been made in the direction of automatic pain assessment, both concerning the creation of datasets and the development of classification algorithms, the literature is lacking regarding the automatic measurement of pain in the setting of cancer patients. Observation by experienced clinical staff and self-assessment by patients could be useful for obtaining the ground truth and, in turn, for training automatic pain recognition systems.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    For the entire duration of the study, patients will remain under the care of the Early Palliative Care and Simultaneous Care Outpatient team of the Istituto Nazionale Tumori, Fondazione Pascale, at home. Pain and other symptoms will be managed according to the good clinical practice and patients will receive assistance in agreement to the routine medical care.

    The following devices will be used:
    1. Software

    2. Instrumentation

    3. Clinical Assessment Tools: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30), Daily Pain Diary, 0-10 numeric rating scale (NRS).

    The project will be divided into three main Work Packages (WPs), dedicated respectively to the creation of the IT infrastructure to support acquisitions (WP1), the patient data collection campaign (WP2), and the development of machine learning algorithms for automatic pain recognition (WP3). The application of the devices and verification of correct functioning will be carried out at the patient's home by the IT staff involved in the study.

    WP1 - The system consists of three main components: the server, with the attached database, the application for mobile devices, also responsible for managing data acquisition from physiological signal acquisition devices, and the desktop application, used by the clinical staff to monitor the progress of data collection.

    The mobile application will have the role of interfacing directly with the patient and acquiring biometric data from wearable devices. Specifically, the following signals will be acquired: heart rate, body temperature, non-invasive blood pressure, and galvanic skin response (GSR). The heart rate will be obtained through a wearable device (Garmin Vivosmart 4) while the body temperature, the non-invasive blood pressure, and the GSR will be acquired by an external device (a BITalino platform).To further validate the accuracy of the algorithm that will deal with pain detection, patients will also be given a QoL questionnaire (EORTC QLQ-C30).

    In order to acquire the ground truth of the data, the patient will be asked to provide feedback on the level of pain, both at certain intervals of time during the day, and in case of acute pain episodes. This feedback can be based on NRS and multimedia strategies (e.g., videos). Patients will fill out a daily pain diary.

    WP2 - The campaign will include a preliminary acquisition phase aimed at testing the IT infrastructure. For obtaining an adequate inter-subject and intra-subject variability, it will be necessary to enroll at least 40 patients, acquiring data for 10-14 days. Thus, the data collection campaign will be conducted for about 6 months. Each subject will use the mobile application and sensors for 2 weeks. Data will be acquired using simultaneously data collection bundles (application, sensors, and any mobile device). Upon enrolment and at the end, EORTC QLQ-C30 will be administered.

    WP3 - The objective is the development of algorithms able to predict the level of pain perceived by the patient. Having a considerable amount of labelled data available, the system will learn from the examples.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Home-Based Telemedicine for Automatic Pain Assessment in Cancer Patients: Dataset Creation and Development of Machine Learning Algorithms
    Actual Study Start Date :
    Jun 21, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Up to 2 weeks]

      Clinical data: Heart rate (beats per minute, bpm)

    2. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Clinical data: Body temperature (Celsius, °C) The patient will use the device provided (BITalino).

    3. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Clinical data: Non-invasive Blood Pressure (mmHg). The patient will use the device provided (BITalino).

    4. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Clinical data: The Galvanic Skin Response (GSR) refers to changes in sweat gland activity that are reflective of the intensity of the emotional state. The patient will use the device provided (BITalino).

    5. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Pain features: A daily Pain Diary will be used. Type: how pain is felt (e.g., sharp, ache, shooting, tingling).

    6. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Pain features: A daily Pain Diary will be used. Degree: 0-10 numeric rating scale (NRS) where 0 is no pain and 10 is the worst pain imaginable.

    7. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Pain features: A daily Pain Diary will be used. Duration (minutes, hours, days).

    8. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Pain features: A daily Pain Diary will be used. Precipitating factors.

    9. To develop a machine learning algorithm useful for predicting the level of pain in cancer patients. A database containing clinical data and pain features will be obtained. [Whenever the patient has a worsening of his/her pain, up to 2 weeks]

      Pain features: A daily Pain Diary will be used. Name and amount of drug used and time it was taken.

    Secondary Outcome Measures

    1. Patients' quality of life assessed by the EORTC QLQ-C30 questionnaire. [At the beginning and at the end of the observation, up to 2 weeks]

      Quality of life (QoL) of patients according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. It is scored on a metric from 0 to 100. Higher scores mean better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged > 18 years

    • Home care patients diagnosed with advanced cancer disease and life expectancy ≤ 1 year

    • Patients receiving treatment for cancer pain

    • Patients who have given their consent

    Exclusion Criteria:
    • Patients aged < 18 years

    • Willingness to sign the informed consent form (unable to read or write)

    • Cognitive deficit (e.g. Alzheimer disease or senile dementia)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Cancer Institute of NaplesNaplesCampaniaItaly80131
    2A.O.U. Federico IINapoliCampaniaItaly

    Sponsors and Collaborators

    • National Cancer Institute, Naples
    • Federico II University

    Investigators

    • Principal Investigator: Marco Cascella, MD, Anesthesia and Pain Medicine. Istituto Nazionale Tumori - IRCCS Fondazione Pascale - Napoli, Italy
    • Principal Investigator: Arturo Cuomo, MD, Anesthesia and Pain Medicine. Istituto Nazionale Tumori - IRCCS Fondazione Pascale - Napoli, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Cancer Institute, Naples
    ClinicalTrials.gov Identifier:
    NCT04726228
    Other Study ID Numbers:
    • 41/20 oss
    First Posted:
    Jan 27, 2021
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute, Naples
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022