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Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Primary Purpose

Colorectal Cancer, Adenoma, Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Implementation of ANL
No included ANL
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Advanced notification letter, Standard invitation, Participation rate, Colonoscopy, Screening, Colorectal Neoplasms, Digestive System Diseases

Eligibility Criteria

55 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Implementation of ANL

No included ANL

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response rate
Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.

Full Information

First Posted
July 11, 2014
Last Updated
July 11, 2014
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, European Union
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1. Study Identification

Unique Protocol Identification Number
NCT02188927
Brief Title
Effect of an Advanced Notification Letter on Screening Colonoscopy Participation
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, European Union

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenoma, Rectal Cancer
Keywords
Advanced notification letter, Standard invitation, Participation rate, Colonoscopy, Screening, Colorectal Neoplasms, Digestive System Diseases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation of ANL
Arm Type
Experimental
Arm Description
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)
Arm Title
No included ANL
Arm Type
Active Comparator
Arm Description
Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy
Intervention Type
Other
Intervention Name(s)
Implementation of ANL
Intervention Description
Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy
Intervention Type
Behavioral
Intervention Name(s)
No included ANL
Intervention Description
Sending Standard Invitation only six weeks before planned screening colonoscopy
Primary Outcome Measure Information:
Title
Participation rate
Description
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.
Time Frame
three months after receiving invitation
Secondary Outcome Measure Information:
Title
Response rate
Description
Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter.
Time Frame
three months after receiving invitation
Other Pre-specified Outcome Measures:
Title
Cost of including Advance Notification Letter
Description
Total cost of including Advanced notification letter into the standard invitation procedure of this study group.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolina Janikowska, MD,MSc
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bartlomiej Kocot
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Director
Facility Information:
Facility Name
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
City
Warsaw
State/Province
Mazovian
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Janikowska, MD, MSc
Phone
22 546 30 58
Ext
+48
Email
kjanikowska@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

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