Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

NCT05412420 | Completed

• 1 other identifier: 2022-A01034-39
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

Electronic survey; Artificial intelligence; Quality of life; Patient-Reported Outcomes (PROs); Symptom management; eHealth; Machine learning

Outcome Measures

Primary Outcomes (1)

• Number of unscheduled medical consultations or re-hospitalisations

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

  3 months

Secondary Outcomes (7)

• Patient Satisfaction

  3 months

• Occurrence of toxicities

  3 months

• Dose of treatments

  3 months

• Adherence to oral treatment

  3 months

• Handling of the digital tool

  3 months

Study Arms (1)

Patient Self-Reporting of Symptoms

EXPERIMENTAL

Other: Patient Self-Reporting of Symptoms

Interventions

Patient Self-Reporting of Symptoms OTHER

At baseline, clinical research staff will: * verify the possibility of an internet connection at the patient's home * help the patient to fill in the 1st questionnaire (baseline questionnaire - frailty) Every two weeks for 3 months: * patients complete questionnaires via app (toxicity; quality of life, medication adherence) * responses are verified by clinical research staff * In case of severe symptoms, the clinician contacts the patient and arranges for management. At the end of the study : \- patients answer a satisfaction questionnaire

Patient Self-Reporting of Symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Study Officials

• LAMBERT AURELIEN, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 9, 2022
• Study Start: August 3, 2022
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)