Colorectal CancerNCT04490733
Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer
A study testing dual-task walking in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- dual-task walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed stage I to III colorectal cancer.
Who cannot join
- Patients with cancer other than colorectal cancer or have cancer recurrence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei
Shiow-Ching Shun, PHD, 886-2-2312-3456 ext. 88439, scshun@ntu.edu.tw
About this study
Official 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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- dual-task walking
- Keywords
- colorectal cancer, cognitive impairment, chemotherapy, dual-task walking, surgery
- Medical subject headings
- Colorectal Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-task walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: dual-task walking |
| Control group | No intervention | Participants in control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Questionnaire
The questionnaires include (1) 37 items to assess perceived cognitive functioning and (2) 6 items to assess perceived cognitive impairment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (1)
Self-report Questionnaire
The questionnaire includes 24 items to assess symptom severity
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start17 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiow-Ching Shun, PHD, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490733
- Sponsor's protocol ID
- 201912231RINC
- Status last verified
- Jun 2025
- First submitted
- 26 Jul 2020
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang HY, Chang YL, Lin BR, Chou YJ, Shun SC. Cognitive Function in Patients at Different Stages of Treatment for Colorectal Cancer: A Comparative Cross-Sectional Study. Semin Oncol Nurs. 2023 Aug;39(4):151446. doi: 10.1016/j.soncn.2023.151446. Epub 2023 May 13.
PubMed 37183103
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04490733
- Acronym / sponsor ID
- 201912231RINC
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cognitive impairment, chemotherapy, dual-task walking, surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: dual-task walkingParticipants 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. |
| Control group | No intervention | –Participants in control group will receive usual care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with newly diagnosed stage I to III colorectal cancer.
Key exclusion criteria (1 listed)
- Patients with cancer other than colorectal cancer or have cancer recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual-task walkingParticipants 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. | Behavioural | Experimental group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 37183103Yang HY, Chang YL, Lin BR, Chou YJ, Shun SC. Cognitive Function in Patients at Different Stages of Treatment for Colorectal Cancer: A Comparative Cross-Sectional Study. Semin Oncol Nurs. 2023 Aug;39(4):151446. doi: 10.1016/j.soncn.2023.151446. Epub 2023 May 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiow-Ching Shun, PHD study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual-task walking in people with Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiow-Ching Shun, PHD (886-911-268-998, scshun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.