Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

NCT02188927 | Unknown

• 1 other identifier: TEAM/2012-9/5
• Study Type: interventional
• Target: 6,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenoma; Rectal Cancer

Keywords

Advanced notification letter; Standard invitation; Participation rate; Colonoscopy; Screening; Colorectal Neoplasms; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response rate

  three months after receiving invitation

Other Outcomes (1)

• Cost of including Advance Notification Letter

  1 year

Study Arms (2)

Implementation of ANL

EXPERIMENTAL

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

No included ANL

ACTIVE COMPARATOR

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

Behavioral: No included ANL

Interventions

Implementation of ANL OTHER

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

Implementation of ANL

No included ANL BEHAVIORAL

Sending Standard Invitation only six weeks before planned screening colonoscopy

No included ANL

Eligibility Criteria

• Age: 55 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Centre of Postgraduate Medical Education: collaborator
• European Union: collaborator

Study Sites (1)

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

Warsaw, Mazovian, Poland

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma; Rectal Neoplasms; Digestive System Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Karolina Janikowska, MD,MSc

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

  PRINCIPAL INVESTIGATOR

• Jaroslaw Regula, MD, PhD

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

  STUDY CHAIR

• Bartlomiej Kocot

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

PL (1)