Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT06684067
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-11-10', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colonoscopy completion rate', 'timeFrame': '90 days', 'description': 'The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization.'}], 'secondaryOutcomes': [{'measure': 'Mental health - anxiety and depression', 'timeFrame': '90 days', 'description': 'The mental health of participants in both arms was assessed pre- and post-colonoscopy using the Hospital Anxiety \\& Depression Scale (HADS). The score may range from 0-21. Scores of 0-7 are normal, 8-10 is mild, 11-14 is moderate and 15-21 is severe anxiety or depression.'}, {'measure': 'Mental health - General psychological distress', 'timeFrame': '90 days', 'description': 'The mental health of participants in both arms was assessed pre- and post-colonoscopy using the General Health Questionnaire 12 (GHQ12) tool as a measure of general psychological distress. Each item in the 12-item questionnaire was scored on a Likert scale of 0-3, for a total score ranging from 0-36. High scores indicate worse health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RCT', 'colorectal cancer screening', 'patient navigation', 'Malaysia', 'depression', 'anxiety', 'HADS', 'GHQ12'], 'conditions': ['Colorectal Cancer Screening', 'Patient Navigation']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question\\[s\\] it aims to answer are:\n\nAre colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?\n\nIs mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?\n\nParticipants in the intervention arm will receive:\n\n* standard clinic instructions for the colonoscopy\n* phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure\n* a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital\n* a direct line for phone calls to patient navigators for further guidance on overcoming barriers\n\nParticipants in the control arm will only receive:\n\n* standard clinic instructions for the colonoscopy\n* one phone call from the patient navigator to discuss the colonoscopy procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Average risk for CRC\n* More than 50 years of age\n* Capacity for informed consent\n* IFOBT positive\n\nExclusion Criteria:\n\n* Moderate or high risk CRC\n* Previous CRC screening\n* Symptomatic'}, 'identificationModule': {'nctId': 'NCT06684067', 'briefTitle': 'Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)', 'orgStudyIdInfo': {'id': 'MREC ID No: 202057-8603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient navigation', 'description': 'Participants in the intervention arm will undergo a patient navigation process', 'interventionNames': ['Behavioral: Patient navigation']}, {'type': 'NO_INTERVENTION', 'label': 'No navigation', 'description': 'Participants in the control arm will receive standard instructions and not undergo the patient navigation process.'}], 'interventions': [{'name': 'Patient navigation', 'type': 'BEHAVIORAL', 'description': 'Participants will receive online educational material, hospital site navigation guidance and direct contact with the patient navigator, in addition to standard instructions on the colonoscopy procedure.', 'armGroupLabels': ['Patient navigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Faculty of Medicine, Universiti Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'April C Roslani, Master of Surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Informed consent was only given for the purposes of this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Malaysia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}