Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Not Applicable

• Conditions: Colorectal Cancer; Rectal Cancer; Adenoma
• Interventions: Behavioral: No included ANL; Other: Implementation of ANL

• Registration Number: NCT02188927
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Last Update Submitted: 2014-07-11
• Study First Posted: 2014-07-14
• Last Update Posted: 2014-07-14
• Study Start: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6800

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No included ANL	No included ANL	Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy
Implementation of ANL	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)

Primary Outcome Measures

Name	Time	Method
Participation rate	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.

Secondary Outcome Measures

Name	Time	Method
Response rate	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.

Trial Locations

Locations (1)

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland; 🇵🇱 Warsaw, Mazovian, Poland