Time Schedules for Sending Invitations to Colonoscopy Screening

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Six and three time schedule; Other: Four and two time schedule

• Registration Number: NCT01505972
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Brief Summary

The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-12-08
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-04
• Last Update Submitted: 2012-01-06
• Study First Posted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Six and three time schedule	Six and three time schedule	-
Four and two time schedule	Four and two time schedule	-

Primary Outcome Measures

Name	Time	Method
Participation rate	6 months from the date of sending invitation letter	Percentage of attenders to screening colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Acceptance rate in SIX &THREE group	3 weeks from the date of sending invitation letter	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Acceptance rate in FOUR&TWO group	2 weeks from the date of sending invitation letter, respectively	Percentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Response rate in SIX&THREE group	3 weeks from the date of sending invitation letter	Percentage of invitees who responded (by phone or letter) before sending a reminder
Response rate in FOUR&TWO group	2 weeks from the date of sending invitation letter	Percentage of invitees who responded (by phone or letter) before sending a reminder

Trial Locations

Locations (1)

Center of Oncology Institute and the Maria Sklodowska-Curie; 🇵🇱 Warsaw, W.K.Roentgena, Poland