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NCT Number: NCT04490733

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

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.

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Key information

Conditions

Colorectal Cancer Cognition Disorders Cognitive Dysfunction Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Neurocognitive Disorders Rectal Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dual-task walking

Behavioral

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.

Primary outcomes

  1. Self-report Questionnaire

    Time frame: 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.

  2. Neuropsychological test battery

    Time frame: 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.

  3. Neuropsychological test battery

    Time frame: 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 attention.

  4. Neuropsychological test battery

    Time frame: 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 memory.

Secondary outcomes

  1. Self-report Questionnaire

    Time frame: 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 questionnaire includes 24 items to assess symptom severity

Other outcomes

  1. Self-report Questionnaire

    Time frame: 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 questionnaire includes 15 items to assess fatigue level

  2. Self-report Questionnaire

    Time frame: 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 questionnaire includes 20 items to assess depressive symptom

Study contacts

Contact information is provided by the study sponsor or research team.

Shiow-Ching Shun, PHD

CONTACT

[email protected]

886-911-268-998

Shiow-Ching Shun, PHD

CONTACT

[email protected]

886-2-28267972

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2020
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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