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Recruiting NCT04490733

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

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dual-task walking.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • National Taiwan University — Taipei

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. PMID 37183103

Identifiers

NCT: NCT04490733 · 201912231RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗