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

NCT ID: NCT05754060

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-04-01

Brief 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.

Conditions

Breast Cancer; Colon Cancer; Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Saint-Louis Lille Battery (SSLIB)

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)

Saint-Louis Lille Battery (SSLIB)

Intervention Type: OTHER

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)

Interventions

Saint-Louis Lille Battery (SSLIB)

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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Catherine Belin, Dr

Role: CONTACT

catherine.belin@aphp.fr

+33171207466

Matthieu Resche Rigon, Pr

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

+33142499742

Other Identifiers

APHP220816

Identifier Type: -

Identifier Source: org_study_id