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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04490733

Collaborator

(none)

355

Enrollment

Location

Arms

47.4

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: dual-task walking	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

355 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 17, 2020

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Participants in the experimental group 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.	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.
No Intervention: Control group Participants in control group will receive usual care.

Arm

Intervention/Treatment

Experimental: Experimental group

Participants in the experimental group 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.

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.

No Intervention: Control group

Participants in control group will receive usual care.

Outcome Measures

Primary Outcome Measures

Self-report Questionnaire [Change from baseline cognitive function at 12 months]
The questionnaire includes 37 items to assess perceived cognitive function
Neuropsychological battery test [Change from baseline cognitive function at 12 months]
Three neuropsychological battery tests will be used to assess cognitive function of executive function.
Neuropsychological battery test [Change from baseline cognitive function at 12 months]
One neuropsychological battery test will be used to assess cognitive function of attention
Neuropsychological battery test [Change from baseline cognitive function at 12 months]
Five neuropsychological battery tests will be used to assess cognitive function of memory

Secondary Outcome Measures

Self-report Questionnaire [Change from baseline symptom at 12 months]
The questionnaire includes 24 items to assess symptom severity

Other Outcome Measures

Self-report Questionnaire [Change from baseline fatigue at 12 months]
The questionnaire includes 15 items to assess fatigue level
Self-report Questionnaire [Change from baseline depression symptom at 12 months]
The questionnaire includes 20 items to assess frequency of depression symptom

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Chair: Shiow-Ching Shun, PHD, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04490733

Other Study ID Numbers:

201912231RINC

First Posted:

Jul 29, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 5, 2021