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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

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of an Advanced Notification Letter on Screening Colonoscopy Participation
Official Title  ICMJE Participation in Screening Colonoscopy in Response to an Advanced Notification Letter Plus Standard Invitation Versus Standard Invitation Only - a Population-based Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Cancer
  • Adenoma
  • Rectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)

    Intervention: Other: Implementation of ANL
  • Active Comparator: No included ANL
    Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy
    Intervention: Behavioral: No included ANL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
6800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188927
Other Study ID Numbers  ICMJE TEAM/2012-9/5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Sklodowska-Curie Institute - Oncology Center
Study Sponsor  ICMJE Maria Sklodowska-Curie Institute - Oncology Center
Collaborators  ICMJE
  • Centre of Postgraduate Medical Education
  • European Union
Investigators  ICMJE
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
PRS Account Maria Sklodowska-Curie Institute - Oncology Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP