Clinical trial NCT05754060: Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
Official title: Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Colon Cancer
Cognitive Impairment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients with breast cancer or colon cancer

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.


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

Primary outcomes:
measure: Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4
timeFrame: At 4 months
Secondary outcomes:
measure: Proportion of patients for which there is a variation of reaction time between the beginning and after the end of the oncological treatment (M12)
timeFrame: At 12 months
measure: Proportion of patients for which there is a variation of reaction time between M4 and M12
timeFrame: At 12 months
measure: Anxiety and depression levels
timeFrame: At inclusion
measure: Anxiety and depression levels
timeFrame: At 4 months
measure: Anxiety and depression levels
timeFrame: At 12 months
measure: Cognitive complaint
timeFrame: At inclusion
measure: Cognitive complaint
timeFrame: At 4 months
measure: Cognitive complaint
timeFrame: At 12 months
measure: Quality of life assessed with the QLQ-C30 questionnaire
timeFrame: At inclusion
measure: Quality of life assessed with the QLQ-C30 questionnaire
timeFrame: At 4 months
measure: Quality of life assessed with the QLQ-C30 questionnaire
timeFrame: At 12 months
Other outcomes:
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