Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients (IASAAC)
Primary Purpose
Solid Tumor
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient Self-Reporting of Symptoms
Sponsored by
About this trial
This is an interventional prevention trial for Solid Tumor focused on measuring Electronic survey, Artificial intelligence, Quality of life, Patient-Reported Outcomes (PROs), Symptom management, eHealth, Machine learning
Eligibility Criteria
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)
Sites / Locations
- Institut de Cancerologie de Lorraine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient Self-Reporting of Symptoms
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient Satisfaction
Patient satisfaction will be assessed according to the Patient Assessment Chronic Illness Care Questionnaire (1= almost never : 5 = almost always)
Occurrence of toxicities
The occurrence of toxicities will be evaluated according to the NCI-CTCAE v5.0 classification
Dose of treatments
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
Adherence to oral treatments will be assessed by the Morisky questionnaire
Handling of the digital tool
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
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.
Predicting the occurrence of sarcopenia
The occurrence of sarcopenia will be measured by the body mass/fat mass ratio using the CT scan performed for tumor evaluation
Full Information
NCT ID
NCT05412420
First Posted
May 30, 2022
Last Updated
July 27, 2023
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT05412420
Brief Title
Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients
Acronym
IASAAC
Official Title
Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor
Keywords
Electronic survey, Artificial intelligence, Quality of life, Patient-Reported Outcomes (PROs), Symptom management, eHealth, Machine learning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Self-Reporting of Symptoms
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Patient Self-Reporting of Symptoms
Intervention Description
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 Outcome Measure Information:
Title
Number of unscheduled medical consultations or re-hospitalisations
Description
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
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction will be assessed according to the Patient Assessment Chronic Illness Care Questionnaire (1= almost never : 5 = almost always)
Time Frame
3 months
Title
Occurrence of toxicities
Description
The occurrence of toxicities will be evaluated according to the NCI-CTCAE v5.0 classification
Time Frame
3 months
Title
Dose of treatments
Description
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
Title
Adherence to oral treatment
Description
Adherence to oral treatments will be assessed by the Morisky questionnaire
Time Frame
3 months
Title
Handling of the digital tool
Description
Handling of the digital tool will be assessed by the System Usability Scale ( 0 =Strongly disagree; 10=Strongly agree)
Time Frame
3 months
Title
Anticipation of the preparation of injectable chemotherapy
Description
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
Title
Predicting the occurrence of sarcopenia
Description
The occurrence of sarcopenia will be measured by the body mass/fat mass ratio using the CT scan performed for tumor evaluation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAMBERT AURELIEN, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients
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