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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490733
• Other study ID #: 201912231RINC
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2021
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, PHD
• Phone: 886-2-23123456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 on improving cognitive function in CRC patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 355
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• dual-task walking
Participants 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-report Questionnaire	The questionnaire includes 15 items to assess fatigue level	Change from baseline fatigue at 12 months
Other	Self-report Questionnaire	The questionnaire includes 20 items to assess frequency of depression symptom	Change from baseline depression symptom at 12 months
Primary	Self-report Questionnaire	The questionnaire includes 37 items to assess perceived cognitive function	Change from baseline cognitive function at 12 months
Primary	Neuropsychological battery test	Three neuropsychological battery tests will be used to assess cognitive function of executive function.	Change from baseline cognitive function at 12 months
Primary	Neuropsychological battery test	One neuropsychological battery test will be used to assess cognitive function of attention	Change from baseline cognitive function at 12 months
Primary	Neuropsychological battery test	Five neuropsychological battery tests will be used to assess cognitive function of memory	Change from baseline cognitive function at 12 months
Secondary	Self-report Questionnaire	The questionnaire includes 24 items to assess symptom severity	Change from baseline symptom at 12 months