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临床试验/NCT04490733
NCT04490733招募中不适用

Developing Risk Prediction Model of Mild Cognitive Impairment in Patients With Colorectal Cancer From Active Treatment to Survivor and Testing the Effect of Dual Task Walking on Improving Cognitive Function

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
355
试验地点
1
主要终点
Neuropsychological test battery

研究概览

简要总结

The aims of this three-year study are to explore cognitive function under different stages of colorectal cancer (CRC) and its related factors; and understand its disturbance and coping process caused by cancer-induced cognitive impairment (CICI) from patient perspective; and further to test effect of dual-task walking on improving cognitive function in CRC patients.

详细描述

In the first phase, a cross-sectional design will be used to explore both subjective and objective cognitive functions under different cancer treatment trajectories of CRC and their related factors. Additionally, a risk prediction model for mild cognitive impairment will be developed by examining the effects of surgery and chemotherapy on cancer-induced cognitive impairment (CICI) , with the aim of identifying high-risk populations. A qualitative design will be employed to understand the disturbances and coping processes caused by CICI from the patient's perspective. A longitudinal design will be used to examine the effects of surgery and chemotherapy on cognitive function. In the second phase, we will develop a dual-task walking training program and use a randomized controlled trial to test its effect on improving cognitive function (memory, executive function, and attention) in CRC patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed stage I to III colorectal cancer.

排除标准

  • Patients with cancer other than colorectal cancer or have cancer recurrence.

结局指标

主要结局

Neuropsychological test battery

时间窗: In the cross-sectional design, data will be collected at a one-time point; in the longitudinal design and the randomized controlled trial, data will be collected at baseline and 3, 6, and 12 months follow-up.

A battery of neuropsychological tests will be used to assess cognitive domains of executive function.

Self-report Questionnaire

时间窗: In the cross-sectional design, data will be collected at a one-time point; in the longitudinal design and the randomized controlled trial, data will be collected at baseline and 3, 6, and 12 months follow-up.

The questionnaires include (1) 37 items to assess perceived cognitive functioning and (2) 6 items to assess perceived cognitive impairment.

次要结局

  • Self-report Questionnaire(In the cross-sectional design, data will be collected at a one-time point; in the longitudinal design and the randomized controlled trial, data will be collected at baseline and 3, 6, and 12 months follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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