Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01183156
Status:
UNKNOWN
Last Update Posted:
2011-02-16
First Post:
2010-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Re-invitation to Screening Colonoscopy: a Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2011-12-01', 'unreleaseDateUnknown': True}, {'resetDate': '2012-04-02', 'releaseDate': '2012-03-05'}, {'resetDate': '2020-04-20', 'releaseDate': '2020-04-10'}], 'estimatedResultsFirstSubmitDate': '2011-12-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010358', 'term': 'Patient Participation'}], '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': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-14', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance to screening colonoscopy', 'timeFrame': '6 months from the date of re-invitation or invitation to educational meeting', 'description': 'Percentage of invitees attending screening colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Response rate to the re-invitation letter or invitation to the educational meeting', 'timeFrame': '3 months from the date of reinvitation letter or date of invitation to the educational meeting', 'description': 'Percentage of invitees sending back reply form'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Screening', 'Colonoscopy', 'Attendance', 'Participation'], 'conditions': ['Colorectal Cancer', 'Screening', 'Patient Participation']}, 'referencesModule': {'references': [{'pmid': '26967693', 'type': 'DERIVED', 'citation': 'Pisera M, Kaminski MF, Kraszewska E, Rupinski M, Regula J. Reinvitation to screening colonoscopy: a randomized-controlled trial of reminding letter and invitation to educational meeting on attendance in nonresponders to initial invitation to screening colonoscopy (REINVITE). Eur J Gastroenterol Hepatol. 2016 May;28(5):538-42. doi: 10.1097/MEG.0000000000000578.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.', 'detailedDescription': 'NordICC (The NordICC Initiative on Colorectal Cancer, NCT00883792) is a multicenter randomised trial to investigate the effect of screening colonoscopy on CRC incidence and mortality. In Poland, in Warsaw area, at least 10,000 subjects 55-64 years of age are to be invited to screening colonoscopy. A personal letter of invitation containing date and hour of appointment is mailed to every individual randomised to the screening group. Up to 60% of invitees do not respond to the initial invitation and reminding letter. The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 55-64 years of age invited for screening colonoscopy within the NordICC trial (NCT00883792) in Poland, who have not responded to the first invitation.\n\nExclusion Criteria:\n\n* Resident abroad\n* Return of unopened letter of invitation and/or reminder (address unknown)\n* Message from neighbour/family/post office on death of screenee (not updated in Population Registry).'}, 'identificationModule': {'nctId': 'NCT01183156', 'acronym': 'REINVITE', 'briefTitle': 'Re-invitation to Screening Colonoscopy: a Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'Re-invitation to Screening Colonoscopy: a Randomized Controlled Trial of Reminding Letter and Educational Intervention on Attendance in Nonresponders to Initial Invitation to Screening Colonoscopy', 'orgStudyIdInfo': {'id': 'NR13002404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Re-invitation letter', 'interventionNames': ['Behavioral: Re-invitation letter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Meeting', 'interventionNames': ['Behavioral: Invitation to educational meeting']}], 'interventions': [{'name': 'Re-invitation letter', 'type': 'BEHAVIORAL', 'description': 'Re-invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.', 'armGroupLabels': ['Re-invitation letter']}, {'name': 'Invitation to educational meeting', 'type': 'BEHAVIORAL', 'description': 'Invitation will be sent 6 weeks prior to educational meeting date and followed by a reminding letter 3 weeks later. Educational meetings will be held in a local culture developement centers and conducted by a medical team responsible for the Polish Colorectal Cancer Screening Program. The aim of the meeting is to overcome barriers to screening colonoscopy. The program of the meeting is tailored to individual needs, doubts, and concerns of the participating group as assessed using brief survey at the beginning of the meeting. The major points to be discussed are: risk and benefit of screening, colorectal cancer risk, pain and sedation, preparation to colonoscopy, consecutive stages of the procedure, comfort and embarrassment.', 'armGroupLabels': ['Educational Meeting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-781', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Kaminski Michal, MD', 'role': 'CONTACT', 'email': 'mfkaminski@coi.waw.pl', 'phone': '+48225463058'}, {'name': 'Pisera Malgorzata, MSc', 'role': 'CONTACT', 'email': 'mpisera@coi.waw.pl', 'phone': '+48225463056'}, {'name': 'Regula Jaroslaw, prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Pisera Malgorzata', 'role': 'CONTACT', 'email': 'mpisera@coi.waw.pl', 'phone': '+48225463056'}, {'name': 'Kaminski Michal', 'role': 'CONTACT', 'email': 'mfkaminski@coi.waw.pl', 'phone': '+48225463058'}], 'overallOfficials': [{'name': 'Regula Jaroslaw, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center'}, {'name': 'Malgorzata Pisera, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center'}, {'name': 'Michal F Kaminski, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center of Oncology Institute and the Maria Sklodowska-Curie Memorial Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research and Development, Poland', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Malgorzata Pisera', 'oldOrganization': 'Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-12-01', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2012-03-05', 'type': 'RELEASE'}, {'date': '2012-04-02', 'type': 'RESET'}, {'date': '2020-04-10', 'type': 'RELEASE'}, {'date': '2020-04-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maria Sklodowska-Curie National Research Institute of Oncology'}}}}