Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT04292366
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimising Colorectal Cancer Screening Participation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of residents participating in colorectal cancer screening', 'timeFrame': 'Within six months after invitaiton', 'description': 'Number of residents participating in colorectal cancer screening in each of the four arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mass screening'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36057390', 'type': 'DERIVED', 'citation': 'Larsen MB, Hedelund M, Flander L, Andersen B. The impact of pre-notifications and reminders on participation in colorectal cancer screening - A randomised controlled trial. Prev Med. 2022 Nov;164:107229. doi: 10.1016/j.ypmed.2022.107229. Epub 2022 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail.\n\nThe main out-come will be participation within 6 months after invitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invited for colorectal cancer screening\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04292366', 'briefTitle': 'Optimising Colorectal Cancer Screening Participation', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures', 'orgStudyIdInfo': {'id': 'participationCRC2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm I', 'description': 'pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)', 'interventionNames': ['Procedure: Invitation procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm II', 'description': 'invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)', 'interventionNames': ['Procedure: Invitation procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm III', 'description': 'pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)', 'interventionNames': ['Procedure: Invitation procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'invitation and one reminder after 45 days (usual care)', 'interventionNames': ['Procedure: Invitation procedure']}], 'interventions': [{'name': 'Invitation procedure', 'type': 'PROCEDURE', 'description': 'Optimised invitation procedures in an organised colorectal cancer screening programme', 'armGroupLabels': ['Control group', 'Intervention arm I', 'Intervention arm II', 'Intervention arm III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}], 'overallOfficials': [{'name': 'Berit Andersen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Randers Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}