Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

NCT02188927 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6800

Last updated 2014-07-14

No results posted yet for this study

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

Interventions

OTHER

Implementation of ANL

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

BEHAVIORAL

No included ANL

Sending Standard Invitation only six weeks before planned screening colonoscopy

Sponsors & Collaborators

  • Centre of Postgraduate Medical Education

    collaborator OTHER
  • European Union

    collaborator OTHER
  • Maria Sklodowska-Curie National Research Institute of Oncology

    lead OTHER

Principal Investigators

  • Karolina Janikowska, MD,MSc · The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

  • Jaroslaw Regula, MD, PhD · The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

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

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188927 on ClinicalTrials.gov