Effect of an Advanced Notification Letter on Screening Colonoscopy Participation
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|ClinicalTrials.gov Identifier: NCT02188927|
Recruitment Status : Unknown
Verified July 2014 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was: Not yet recruiting
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
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.
We 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.
This 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.
Material 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Adenoma Rectal Cancer||Other: Implementation of ANL Behavioral: No included ANL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||February 2015|
Experimental: Implementation of ANL
Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure
Advanced 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)
Other: Implementation of ANL
Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy
Active Comparator: No included ANL
Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy
Behavioral: No included ANL
Sending Standard Invitation only six weeks before planned screening colonoscopy
- Participation rate [ Time Frame: three months after receiving invitation ]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.
- Response rate [ Time Frame: three months after receiving invitation ]Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.
- Cost of including Advance Notification Letter [ Time Frame: 1 year ]Total cost of including Advanced notification letter into the standard invitation procedure of this study group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188927
|The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland|
|Warsaw, Mazovian, Poland|
|Contact: Karolina Janikowska, MD, MSc 22 546 30 58 ext +48 firstname.lastname@example.org|
|Principal Investigator:||Karolina Janikowska, MD,MSc||The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland|
|Study Chair:||Jaroslaw Regula, MD, PhD||The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland|
|Study Director:||Bartlomiej Kocot||The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland|