Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 7
- 主要终点
- Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care
研究概览
简要总结
Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint
详细描述
The main objective of our study was to evaluate, in patients treated for cancer expressing the cognitive complaint during or after treatment, interest workshops on improving cognitive rehabilitation felt their cognitive functions and their quality of life.
The primary endpoint was the proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after treatment. The FACT-Cog is a self-administered questionnaire assessing the patients felt their cognitive difficulties (memory, attention, concentration) and the impact of these difficulties on their quality of life. The improvement is defined as an increase of 7 points >= cognitive score won by the (a) patient (e) after the treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Solid tumor or haematological
- •Chemotherapy and / or targeted therapy in the adjuvant or metastatic
- •Sequential processing
- •Subjective cognitive complaints during or after treatment assessed by four items of the FACT-COG (impact on quality of life). Score ≥ 4/16 questions Q35, Q37, Q38 and Q41 FACT COG - Patient in remission or pause therapeutic
- •Subjective between 1 month and 5 years after the end of chemotherapy and / or targeted therapy cognitive complaints (ongoing treatment with Herceptin is not a non-inclusion criteria)
- •Lack of personality disorders and / or psychiatric disorder scalable
- •No known brain metastases
- •Lack of primary brain tumor
- •Lack of analgesic treatment with opioids or Class 3
- •Having signed informed consent to participate in the study
- •Mastery of the French language
排除标准
- •Primary cancer of the central nervous system or brain metastases
- •Pathology malignant hematologic
- •Disorders of higher functions documented
- •Pathology psychiatric scalable
- •Use documented drug
- •Cancer treated in childhood
- •Patient or opioids analgesics in Class 3
- •Consumption of alcohol
- •Patient unable to respond to cognitive tests and cognitive rehabilitation
- •Refusal to participate
研究组 & 干预措施
Experimental group
Cognitive exams at T0 and T3. Patients will achieve 9 standardized cognitive rehabilitation sessions with the RehaCom ® software (over 3 months), and a self-assessment of their monthly experienced cognitive functioning using the self-administered questionnaire FACT-Cog
干预措施: Cognitive exams (Other)
Experimental group
Cognitive exams at T0 and T3. Patients will achieve 9 standardized cognitive rehabilitation sessions with the RehaCom ® software (over 3 months), and a self-assessment of their monthly experienced cognitive functioning using the self-administered questionnaire FACT-Cog
干预措施: standardized cognitive rehabilitation (Other)
The control group 1 (Homework)
Cognitive exams at T0 and T3. These patients will take part in 9 sessions standardized home exercise (over 3 months), and a self-assessment every month felt their cognitive functioning using the self-administered questionnaire FACT Cog
干预措施: Cognitive exams (Other)
The control group 1 (Homework)
Cognitive exams at T0 and T3. These patients will take part in 9 sessions standardized home exercise (over 3 months), and a self-assessment every month felt their cognitive functioning using the self-administered questionnaire FACT Cog
干预措施: Standardized home exercise (Other)
Control group 2 ( telephone follow)
Cognitive exams at T0 and T3. These patients receive follow-up by phone (9 telephone calls over a period of 3 months) standardized optics to know the evolution of the disorder and felt the same way as for the other groups, a monthly self-assessment the feeling of cognitive functioning using the self-administered questionnaire FACT-Cog
干预措施: Cognitive exams (Other)
Control group 2 ( telephone follow)
Cognitive exams at T0 and T3. These patients receive follow-up by phone (9 telephone calls over a period of 3 months) standardized optics to know the evolution of the disorder and felt the same way as for the other groups, a monthly self-assessment the feeling of cognitive functioning using the self-administered questionnaire FACT-Cog
干预措施: Follow up by phone (Other)
结局指标
主要结局
Proportion of patients showing an improvement in the score of perceived deficiencies (score ranging from 0 to 72) of the FACT-Cog after care
时间窗: up to 3 months
Evaluate, in patients treated for cancer expressing a cognitive complaint during or after the treatment, the interest workshops on improving cognitive rehabilitation felt their cognitive function and quality of life. Autoquestionnary FACT COG
次要结局
- Evaluate the relationship between cognitive impairment and the parameters of the quality of life(Baseline and month 3)
- Assess the relationships between goals disorders (measured by neuropsychological tests) and the patients felt(Baseline and month 3)
- Study of different types of interest support the evolution of objective and subjective cognitive performance of patients(Baseline and month 3)