CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- The effectiveness of a 10-week cognitive rehabilitation program
研究概览
简要总结
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
详细描述
This interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting CRCI in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
A total of 128 patients will be randomized 1:1 into two groups:
- Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed.
- Control group, which will only carry out neuropsychological assessments.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signature of informed consent
- •Diagnosis of operable/operated breast cancer
- •Patients candidate to be treated with Neo/adjuvant chemotherapy
排除标准
- •Previous chemotherapy treatments
- •Patients with Metastatic breast cancer
- •Patients affected by pathologies of the brain, head trauma, and intellectual disabilities
- •Patients affected by previous or current neurological and/or psychiatric disorders
- •Patients currently treated with psychopharmacological drug
结局指标
主要结局
The effectiveness of a 10-week cognitive rehabilitation program
时间窗: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed.
次要结局
- Analysis of cognitive function trends in the control group(Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started))