Clinical Trial: Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Dates:
Date Received: July 11, 2014
Date Started: August 2014
Date Completion: February 2015
Last Updated: July 11, 2014
Last Verified: July 2014