Re-invitation to Screening Colonoscopy: a Randomized Study

Not Applicable

• Conditions: Colorectal Cancer; Screening; Patient Participation
• Interventions: Behavioral: Re-invitation letter; Behavioral: Invitation to educational meeting

• Registration Number: NCT01183156
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary

The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.

Detailed Description

NordICC (The NordICC Initiative on Colorectal Cancer, NCT00883792) is a multicenter randomised trial to investigate the effect of screening colonoscopy on CRC incidence and mortality. In Poland, in Warsaw area, at least 10,000 subjects 55-64 years of age are to be invited to screening colonoscopy. A personal letter of invitation containing date and hour of appointment is mailed to every individual randomised to the screening group. Up to 60% of invitees do not respond to the initial invitation and reminding letter. The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-14
• Last Update Posted: 2011-02-16
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Men and women 55-64 years of age invited for screening colonoscopy within the NordICC trial (NCT00883792) in Poland, who have not responded to the first invitation.

Exclusion Criteria

• Resident abroad
• Return of unopened letter of invitation and/or reminder (address unknown)
• Message from neighbour/family/post office on death of screenee (not updated in Population Registry).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Re-invitation letter	Re-invitation letter	-
Educational Meeting	Invitation to educational meeting	-

Primary Outcome Measures

Name	Time	Method
Attendance to screening colonoscopy	6 months from the date of re-invitation or invitation to educational meeting	Percentage of invitees attending screening colonoscopy

Secondary Outcome Measures

Name	Time	Method
Response rate to the re-invitation letter or invitation to the educational meeting	3 months from the date of reinvitation letter or date of invitation to the educational meeting	Percentage of invitees sending back reply form

Trial Locations

Locations (1)

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology; 🇵🇱 Warsaw, Poland