Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4
时间窗: At 4 months
The variation will be defined as follows : * Mild if the reaction times vary for only one of the Saint-Louis Lille Battery (SLLIB) tests * Moderate if the variation appears on two of the SLLIB tests * Severe if the variation appears on three of the SLLIB tests
次要结局
- Anxiety and depression levels(At 12 months)
- Cognitive complaint(At 12 months)
- Quality of life assessed with the QLQ-C30 questionnaire(At 12 months)
- Proportion of patients for which there is a variation of reaction time between the beginning and after the end of the oncological treatment (M12)(At 12 months)
- Proportion of patients for which there is a variation of reaction time between M4 and M12(At 12 months)