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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: dual-task walking

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 355
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiow-Ching Shun, PHD; Phone Number: 886-911-268-998; Email: scshun@ntu.edu.tw
• Study Contact Backup: Name: Shiow-Ching Shun, PHD; Phone Number: 886-2-28267972; Email: scshun@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University
    • Contact: Shiow-Ching Shun, PHD; Phone Number: 88439 886-2-2312-3456; Email: scshun@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants in control group will receive usual care.
Experimental: Experimental group; Participants in the experimental group will receive 3 times interventions during chemotherapy and 12 weekly phone calls or via LINE to assess barriers of dual-task walking.	Behavioral: dual-task walking; Participants in the experimental group will receive 3 times interventions during chemotherapy and 12 weekly phone calls or via LINE to assess barriers of dual-task walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaires include (1) 37 items to assess perceived cognitive functioning and (2) 6 items to assess perceived cognitive impairment.	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.
Neuropsychological test battery	A battery of neuropsychological tests will be used to assess cognitive domains of executive function.	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.
Neuropsychological test battery	A battery of neuropsychological tests will be used to assess cognitive domains of attention.	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.
Neuropsychological test battery	A battery of neuropsychological tests will be used to assess cognitive domains of memory.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaire includes 24 items to assess symptom severity	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaire includes 15 items to assess fatigue level	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.
Self-report Questionnaire	The questionnaire includes 20 items to assess depressive symptom	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.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Shiow-Ching Shun, PHD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; chemotherapy; surgery; cognitive impairment; dual-task walking
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 201912231RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No