Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Study Overview
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Brief Summary
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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.

Official Title
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Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial

Conditions
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Colorectal Cancer, Adenoma, Rectal Cancer

Intervention / Treatment
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* Other: Implementation of ANL
* Behavioral: No included ANL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: message from neighbor/family/post office on death of screenee (not updated in Population Registry) resident abroad (not updated in Population Registry) return of unopened letter of invitation and/or reminder (address unknown) diagnosis of CRC before the date of draw (not updated in the National Cancer Registry)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation of ANL<br>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<br>* Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy<br>|
| Active Comparator: No included ANL<br>Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy | Behavioral: No included ANL<br>* Sending Standard Invitation only six weeks before planned screening colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | 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. | three months after receiving invitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter. | three months after receiving invitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced notification letter, Standard invitation, Participation rate, Colonoscopy, Screening, Colorectal Neoplasms, Digestive System Diseases