Skip to main content
OpenTrials
Completed

NCT Number: NCT05412420

Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Number of unscheduled medical consultations or re-hospitalisations

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 3 months

    Patient satisfaction will be assessed according to the Patient Assessment Chronic Illness Care Questionnaire (1= almost never : 5 = almost always)

  2. Occurrence of toxicities

    Time frame: 3 months

    The occurrence of toxicities will be evaluated according to the NCI-CTCAE v5.0 classification

  3. Dose of treatments

    Time frame: 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.

  4. Adherence to oral treatment

    Time frame: 3 months

    Adherence to oral treatments will be assessed by the Morisky questionnaire

  5. Handling of the digital tool

    Time frame: 3 months

    Handling of the digital tool will be assessed by the System Usability Scale ( 0 =Strongly disagree; 10=Strongly agree)

  6. Anticipation of the preparation of injectable chemotherapy

    Time frame: 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.

  7. Predicting the occurrence of sarcopenia

    Time frame: 3 months

    The occurrence of sarcopenia will be measured by the body mass/fat mass ratio using the CT scan performed for tumor evaluation

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: IASAAC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.