Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Adenoma; Rectal Cancer
• Intervention / Treatment: Other: Implementation of ANL; Behavioral: No included ANL

• Study Type: Interventional
• Enrollment (Anticipated): 6800
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of including Advance Notification Letter	Total cost of including Advanced notification letter into the standard invitation procedure of this study group.	1 year

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Centre of Postgraduate Medical Education; European Union
• Investigators: Principal Investigator: Karolina Janikowska, MD,MSc, 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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Screening; Digestive System Diseases; Colonoscopy; Colorectal Neoplasms; Advanced notification letter; Standard invitation; Participation rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: TEAM/2012-9/5