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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Behavioral: dual-task walking

• Registration Number: NCT04490733
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Study Start: 2020-08-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-05
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Patients with newly diagnosed stage I to III colorectal cancer and Montreal Cognitive Assessment (MoCA) < 24.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	dual-task walking	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.

Primary Outcome Measures

Name	Time	Method
Neuropsychological battery test	Change from baseline cognitive function at 12 months	Five neuropsychological battery tests will be used to assess cognitive function of memory
Self-report Questionnaire	Change from baseline cognitive function at 12 months	The questionnaire includes 37 items to assess perceived cognitive function

Secondary Outcome Measures

Name	Time	Method
Self-report Questionnaire	Change from baseline symptom at 12 months	The questionnaire includes 24 items to assess symptom severity

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, Taiwan