Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54500, France
NCT Number: NCT05412420
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vandœuvre-lès-Nancy, 54500, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At baseline, clinical research staff will:
Every two weeks for 3 months:
At the end of the study :
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.
Time frame: 3 months
Patient satisfaction will be assessed according to the Patient Assessment Chronic Illness Care Questionnaire (1= almost never : 5 = almost always)
Time frame: 3 months
The occurrence of toxicities will be evaluated according to the NCI-CTCAE v5.0 classification
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.
Time frame: 3 months
Adherence to oral treatments will be assessed by the Morisky questionnaire
Time frame: 3 months
Handling of the digital tool will be assessed by the System Usability Scale ( 0 =Strongly disagree; 10=Strongly agree)
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.
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
Institut de Cancérologie de Lorraine
Other
Acronym: IASAAC
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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.
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