Time Schedules for Sending Invitations to Colonoscopy Screening
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | December 8, 2011 | ||||||||||||
| Last Updated Date | January 6, 2012 | ||||||||||||
| Start Date ICMJE | March 2011 | ||||||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Participation rate [ Time Frame: 6 months from the date of sending invitation letter ] [ Designated as safety issue: No ] Percentage of attenders to screening colonoscopy. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01505972 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Time Schedules for Sending Invitations to Colonoscopy Screening | ||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||
| Brief Summary | The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Colorectal Cancer | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 1600 | ||||||||||||
| Completion Date | September 2011 | ||||||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion criteria: Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial. Exclusion criteria:
Exclusion criteria for colonoscopy:
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| Gender | Both | ||||||||||||
| Ages | 55 Years to 64 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Poland | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01505972 | ||||||||||||
| Other Study ID Numbers ICMJE | NR13002404_1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology | ||||||||||||
| Study Sponsor ICMJE | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology | ||||||||||||
| Collaborators ICMJE | The National Centre for Research and Development, Poland | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology | ||||||||||||
| Verification Date | January 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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