Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Developing risk prediction model of mild cognitive impairment in patients with colorectal cancer from active treatment to survivor by exploring the effect of surgery and chemotherapy on CICI, and to identify high risk population; and testing the effect of dual-task walking on improving cognitive function (memory, executive function and attention) in CRC patients.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: dual-task walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly diagnosed stage I to III colorectal cancer and Montreal Cognitive Assessment (MoCA) < 24. Exclusion Criteria: Patients with cancer other than colorectal cancer or have cancer recurrence.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants in the experimental group will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking. | Behavioral: dual-task walking<br>* Participants will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.<br>|
| No Intervention: Control group<br>Participants in control group will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report Questionnaire | The questionnaire includes 37 items to assess perceived cognitive function | Change from baseline cognitive function at 12 months | 
| Neuropsychological battery test | Three neuropsychological battery tests will be used to assess cognitive function of executive function. | Change from baseline cognitive function at 12 months | 
| Neuropsychological battery test | One neuropsychological battery test will be used to assess cognitive function of attention | Change from baseline cognitive function at 12 months | 
| Neuropsychological battery test | Five neuropsychological battery tests will be used to assess cognitive function of memory | Change from baseline cognitive function at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report Questionnaire | The questionnaire includes 24 items to assess symptom severity | Change from baseline symptom at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, cognitive impairment, chemotherapy, dual-task walking