Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

Not Applicable

Completed

• Conditions: Solid Tumor
• Interventions: Other: Patient Self-Reporting of Symptoms

• Registration Number: NCT05412420
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

During treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive.

Currently, adverse effects and toxicities are well codified in the oncology community, notably via the NCI CTCAE criteria.

Unlike objective data such as a blood sample or a CTscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). Several studies had already highlighted the discrepancies between medical and patient data collection.

Self-assessment of symptoms is one way to overcome this bias. Moreover, there are now a large number of solutions that allow to perform these self-assessments at home.

Thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form.

These new evaluation methods also allow to take a quality of life approach. Patient-reported outcomes (PROs) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers.

The goal of this study is to go one step further than the previous PROs studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2022-08-03
• Primary Completion: 2023-10-13
• Study Completion: 2023-10-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Follow-up for a solid tumor
• Chemotherapy treatment (oral and/or injectable) scheduled or in progress
• Life expectancy > 3 months
• Performance Status (PS) < 3
• Have an internet connection or assistance to answer questions throughout the study (nurse, family members, etc.)
• Patient having understood, signed and dated the consent form
• Patient affiliated to the social security system

Exclusion Criteria

• Lack of means to answer the online questionnaires
• Patient in another therapeutic trial with an experimental molecule
• Patients and their families who cannot read or speak French
• Persons deprived of liberty or under guardianship (including curatorship)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient Self-Reporting of Symptoms	Patient Self-Reporting of Symptoms	-

Primary Outcome Measures

Name	Time	Method
Number of unscheduled medical consultations or re-hospitalisations	3 months	The number of unscheduled medical consultations or re-hospitalisations will be assessed based on abnormalities identified through the patient's self-report of symptoms.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	3 months	Patient satisfaction will be assessed according to the Patient Assessment Chronic Illness Care Questionnaire (1= almost never : 5 = almost always)
Dose of treatments	3 months	The total dose of treatments given will be calculated from the total dose of chemotherapy received per course and the collection of dose adjustments.
Adherence to oral treatment	3 months	Adherence to oral treatments will be assessed by the Morisky questionnaire
Handling of the digital tool	3 months	Handling of the digital tool will be assessed by the System Usability Scale ( 0 =Strongly disagree; 10=Strongly agree)
Anticipation of the preparation of injectable chemotherapy	3 months	Anticipation of injectable chemotherapy preparations will be evaluated based on the number of treatments ordered and actually administered, without the need to call the patient.
Occurrence of toxicities	3 months	The occurrence of toxicities will be evaluated according to the NCI-CTCAE v5.0 classification
Predicting the occurrence of sarcopenia	3 months	The occurrence of sarcopenia will be measured by the body mass/fat mass ratio using the CT scan performed for tumor evaluation

Trial Locations

Locations (1)

Institut de Cancerologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France