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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: dual-task walking

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 Type: Interventional
• Enrollment (Anticipated): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaire includes 37 items to assess perceived cognitive function	Change from baseline cognitive function at 12 months
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
Neuropsychological battery test	One neuropsychological battery test will be used to assess cognitive function of attention	Change from baseline cognitive function at 12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaire includes 24 items to assess symptom severity	Change from baseline symptom at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Questionnaire	The questionnaire includes 15 items to assess fatigue level	Change from baseline fatigue at 12 months
Self-report Questionnaire	The questionnaire includes 20 items to assess frequency of depression symptom	Change from baseline depression symptom at 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2020
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): July 31, 2024

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; chemotherapy; cognitive impairment; dual-task walking
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 201912231RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No