Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-09 @ 3:55 AM
Study NCT ID:
NCT04490733
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2020-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 355}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-26', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-report Questionnaire', 'timeFrame': '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.', 'description': 'The questionnaire includes 15 items to assess fatigue level'}, {'measure': 'Self-report Questionnaire', 'timeFrame': '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.', 'description': 'The questionnaire includes 20 items to assess depressive symptom'}], 'primaryOutcomes': [{'measure': 'Self-report Questionnaire', 'timeFrame': '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.', 'description': 'The questionnaires include (1) 37 items to assess perceived cognitive functioning and (2) 6 items to assess perceived cognitive impairment.'}, {'measure': 'Neuropsychological test battery', 'timeFrame': '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.', 'description': 'A battery of neuropsychological tests will be used to assess cognitive domains of executive function.'}, {'measure': 'Neuropsychological test battery', 'timeFrame': '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.', 'description': 'A battery of neuropsychological tests will be used to assess cognitive domains of attention.'}, {'measure': 'Neuropsychological test battery', 'timeFrame': '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.', 'description': 'A battery of neuropsychological tests will be used to assess cognitive domains of memory.'}], 'secondaryOutcomes': [{'measure': 'Self-report Questionnaire', 'timeFrame': '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.', 'description': 'The questionnaire includes 24 items to assess symptom severity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'cognitive impairment', 'chemotherapy', 'dual-task walking', 'surgery'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37183103', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed stage I to III colorectal cancer.\n\nExclusion Criteria:\n\n* Patients with cancer other than colorectal cancer or have cancer recurrence.'}, 'identificationModule': {'nctId': 'NCT04490733', 'briefTitle': 'Developing Risk Prediction Model and Testing the Effect of Dual Task Walking on Improving Cognitive Function in Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '201912231RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '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.', 'interventionNames': ['Behavioral: dual-task walking']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants in control group will receive usual care.'}], 'interventions': [{'name': 'dual-task walking', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shiow-Ching Shun, PHD', 'role': 'CONTACT', 'email': 'scshun@ntu.edu.tw', 'phone': '886-2-2312-3456', 'phoneExt': '88439'}], 'facility': 'National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shiow-Ching Shun, PHD', 'role': 'CONTACT', 'email': 'scshun@ntu.edu.tw', 'phone': '886-911-268-998'}, {'name': 'Shiow-Ching Shun, PHD', 'role': 'CONTACT', 'email': 'scshun@nycu.edu.tw', 'phone': '886-2-28267972'}], 'overallOfficials': [{'name': 'Shiow-Ching Shun, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}