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Trial Title:
Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
NCT ID:
NCT05754060
Condition:
Breast Cancer
Colon Cancer
Cognitive Impairment
Conditions: Official terms:
Nervous System Neoplasms
Cognitive Dysfunction
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Saint-Louis Lille Battery (SSLIB)
Description:
Saint-Louis Lille Battery (SSLIB) composed of three tests studying the speed of cognitive
processing and proposed to the subjects on a tactile tablet. These three tasks are:
(a) Reaction time tasks specifically developed for this study b) A digital adaptation of
the WAIS-IV code subtest c) A digital version of the Trail Making Test (A and B)
Arm group label:
Saint-Louis Lille Battery (SSLIB)
Summary:
Cancer is a frequent disease considering that one person out of three will be confronted
with it in their lifetime. Cancer patients often express complaints related to cognitive
impairment as an outcome of their oncological treatment. These cognitive disorders have a
significant impact on the patient's and their carer's quality of life. Therefore, it
appears necessary to have a reliable, quick and simple tool in order to detect cognitive
impairment.
The rationale of this study relies on 3 main points :
- The cognitive complaint frequently reported by cancer patients
- The difficulty in reliably demonstrating the cause of this complaint through
conventional neuropsychological tests
- The interest of cognitive processing speed as an indicator of cognitive dysfunction
The primary objective of the study is to evaluate a potential variation of cognitive
processing speed at the Saint-Louis Lille Battery (SSLIB) between the beginning and
during (4 months after the beginning) the oncological treatment of adults with breast
cancer or colon cancer.
Criteria for eligibility:
Study pop:
Adults patients with breast cancer or colon cancer
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Beginning an oncological treatment for breast or colon cancer
- Patients of age ≥ 20 and ≤ 70 years old
- Cancer diagnosis announcement delivered since less than 3 weeks (+/- a week)
- Patient affiliated to French social security
Exclusion Criteria:
- Patient's opposition to the study
- Notion of an abnormal cerebral scan or MRI
- Drug use (alcohol, narcotics...)
- Chronic (≥ 15 days) treatment with corticosteroids > 1mg/kg/j (prednisone or
equivalent)
- Ocular pathology or cognitive disorder impairing comprehension and reading abilities
- Patients under curatorship, guardianship or under the protection of justice
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
April 1, 2023
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754060
