Clinical trial NCT02188927: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Adenoma
Rectal Cancer
Keywords: Advanced notification letter
Standard invitation
Participation rate
Colonoscopy
Screening
Colorectal Neoplasms
Digestive System Diseases
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
name: European Union
First posted: 2014-07-14
Enrollment: 6800
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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)

Primary outcomes:
measure: Participation rate
timeFrame: three months after receiving invitation
Secondary outcomes:
measure: Response rate
timeFrame: three months after receiving invitation
Other outcomes:
measure: Cost of including Advance Notification Letter
timeFrame: 1 year
Locations:
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
state: Mazovian
Study officials:
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Karolina Janikowska, MD,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Jaroslaw Regula, MD, PhD
role: STUDY_CHAIR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Bartlomiej Kocot
role: STUDY_DIRECTOR
References: