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Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

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ClinicalTrials.gov Identifier: NCT02188927
Recruitment Status : Unknown
Verified July 2014 by Maria Sklodowska-Curie Institute - Oncology Center.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborators:
Centre of Postgraduate Medical Education
European Union
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Adenoma Rectal Cancer Other: Implementation of ANL Behavioral: No included ANL Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : August 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Cost of including Advance Notification Letter [ Time Frame: 1 year ]
    Total cost of including Advanced notification letter into the standard invitation procedure of this study group.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188927


Locations
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Poland
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Warsaw, Mazovian, Poland
Contact: Karolina Janikowska, MD, MSc    22 546 30 58 ext +48    kjanikowska@gmail.com   
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Centre of Postgraduate Medical Education
European Union
Investigators
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Principal Investigator: Karolina Janikowska, MD,MSc The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Study Chair: Jaroslaw Regula, MD, PhD 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
More Information
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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT02188927    
Other Study ID Numbers: TEAM/2012-9/5
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Advanced notification letter
Standard invitation
Participation rate
Colonoscopy
 Screening
Colorectal Neoplasms
Digestive System Diseases
Additional relevant MeSH terms:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type