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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
dual-task walking
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer, cognitive impairment, chemotherapy, dual-task walking

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Taiwan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

Participants in control group will receive usual care.

Outcomes

Primary Outcome Measures

Self-report Questionnaire
The questionnaire includes 37 items to assess perceived cognitive function
Neuropsychological battery test
Three neuropsychological battery tests will be used to assess cognitive function of executive function.
Neuropsychological battery test
One neuropsychological battery test will be used to assess cognitive function of attention
Neuropsychological battery test
Five neuropsychological battery tests will be used to assess cognitive function of memory

Secondary Outcome Measures

Self-report Questionnaire
The questionnaire includes 24 items to assess symptom severity

Full Information

First Posted
July 26, 2020
Last Updated
August 3, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04490733
Brief Title
Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, cognitive impairment, chemotherapy, dual-task walking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in control group will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
dual-task walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 37 items to assess perceived cognitive function
Time Frame
Change from baseline cognitive function at 12 months
Title
Neuropsychological battery test
Description
Three neuropsychological battery tests will be used to assess cognitive function of executive function.
Time Frame
Change from baseline cognitive function at 12 months
Title
Neuropsychological battery test
Description
One neuropsychological battery test will be used to assess cognitive function of attention
Time Frame
Change from baseline cognitive function at 12 months
Title
Neuropsychological battery test
Description
Five neuropsychological battery tests will be used to assess cognitive function of memory
Time Frame
Change from baseline cognitive function at 12 months
Secondary Outcome Measure Information:
Title
Self-report Questionnaire
Description
The questionnaire includes 24 items to assess symptom severity
Time Frame
Change from baseline symptom at 12 months
Other Pre-specified Outcome Measures:
Title
Self-report Questionnaire
Description
The questionnaire includes 15 items to assess fatigue level
Time Frame
Change from baseline fatigue at 12 months
Title
Self-report Questionnaire
Description
The questionnaire includes 20 items to assess frequency of depression symptom
Time Frame
Change from baseline depression symptom at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiow-Ching Shun, PHD
Phone
886-2-23123456
Ext
88439
Email
scshun@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiow-Ching Shun, PHD
Phone
886-2-2312-3456
Ext
88439
Email
scshun@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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