Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02188927
Status:
UNKNOWN
Last Update Posted:
2014-07-14
First Post:
2014-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of an Advanced Notification Letter on Screening Colonoscopy Participation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], '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': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost of including Advance Notification Letter', 'timeFrame': '1 year', 'description': 'Total cost of including Advanced notification letter into the standard invitation procedure of this study group.'}], 'primaryOutcomes': [{'measure': 'Participation rate', 'timeFrame': 'three months after receiving invitation', 'description': 'A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'three months after receiving invitation', 'description': "Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced notification letter', 'Standard invitation', 'Participation rate', 'Colonoscopy', 'Screening', 'Colorectal Neoplasms', 'Digestive System Diseases'], 'conditions': ['Colorectal Cancer', 'Adenoma', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program.\n\nWe hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program.\n\nThis randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone.\n\nMaterial and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all individuals aged 55-64 years living in the counties covered with the organized CRC screening program and assigned to invitation to screening colonoscopy in the year 2014 are eligible for the study.\n\nExclusion Criteria:\n\n* message from neighbor/family/post office on death of screenee (not updated in Population Registry)\n* resident abroad (not updated in Population Registry)\n* return of unopened letter of invitation and/or reminder (address unknown)\n* diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)'}, 'identificationModule': {'nctId': 'NCT02188927', 'briefTitle': 'Effect of an Advanced Notification Letter on Screening Colonoscopy Participation', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TEAM/2012-9/5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implementation of ANL', 'description': 'Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure\n\nAdvanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy)', 'interventionNames': ['Other: Implementation of ANL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No included ANL', 'description': 'Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy', 'interventionNames': ['Behavioral: No included ANL']}], 'interventions': [{'name': 'Implementation of ANL', 'type': 'OTHER', 'description': 'Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy', 'armGroupLabels': ['Implementation of ANL']}, {'name': 'No included ANL', 'type': 'BEHAVIORAL', 'description': 'Sending Standard Invitation only six weeks before planned screening colonoscopy', 'armGroupLabels': ['No included ANL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'state': 'Mazovian', 'country': 'Poland', 'contacts': [{'name': 'Karolina Janikowska, MD, MSc', 'role': 'CONTACT', 'email': 'kjanikowska@gmail.com', 'phone': '22 546 30 58', 'phoneExt': '+48'}], 'facility': 'The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Karolina Janikowska, MD,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland'}, {'name': 'Jaroslaw Regula, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland'}, {'name': 'Bartlomiej Kocot', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, {'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}