Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients (RIVAGE)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Breast Cancer; Cognitive Impairment; Colon Cancer

Treatments: Other: Saint-Louis Lille Battery (SSLIB)

Study type: Observational

Funder types: Other

Identifiers

NCT05754060

APHP220816

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Saint-Louis Lille Battery (SSLIB)

Description:

Saint-Louis Lille Battery (SSLIB) is 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)

Treatment:

Other: Saint-Louis Lille Battery (SSLIB)