Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Colorectal Cancer Adenoma Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Implementation of ANL

Intervention Type OTHER

Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy

No included ANL

Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy

Group Type ACTIVE_COMPARATOR

No included ANL

Intervention Type BEHAVIORAL

Sending Standard Invitation only six weeks before planned screening colonoscopy

Interventions

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Implementation of ANL

Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy

Intervention Type OTHER

No included ANL

Sending Standard Invitation only six weeks before planned screening colonoscopy

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

55 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No