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Time Schedules for Sending Invitations to Colonoscopy Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01505972
Enrollment
1600
Registered
2012-01-09
Start date
2011-03-31
Completion date
2011-09-30
Last updated
2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

screening colonoscopy, attendance, response, colorectal cancer

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.

Interventions

OTHERSix and three time schedule

Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.

OTHERFour and two time schedule

Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.

Sponsors

National Center for Research and Development, Poland
CollaboratorOTHER
Maria Sklodowska-Curie National Research Institute of Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.

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).

Design outcomes

Primary

MeasureTime frameDescription
Participation rate6 months from the date of sending invitation letterPercentage of attenders to screening colonoscopy.

Secondary

MeasureTime frameDescription
Acceptance rate in SIX &THREE group3 weeks from the date of sending invitation letterPercentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Acceptance rate in FOUR&TWO group2 weeks from the date of sending invitation letter, respectivelyPercentage of invitees who agreed (by phone or letter) to participate in screening colonoscopy before sending a reminder
Response rate in SIX&THREE group3 weeks from the date of sending invitation letterPercentage of invitees who responded (by phone or letter) before sending a reminder
Response rate in FOUR&TWO group2 weeks from the date of sending invitation letterPercentage of invitees who responded (by phone or letter) before sending a reminder

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026