Time Schedules for Sending Invitations to Colonoscopy Screening

Study Overview
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Brief Summary
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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.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Six and three time schedule
* Other: Four and two time schedule


Participation Criteria
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Eligibility Criteria
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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). Exclusion criteria for colonoscopy: Individuals with previous colorectal surgery (resections, enterostomies) Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation). On-going cytotoxic treatment or radiotherapy for malignant disease Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease Lifelong anticoagulant therapy with Warfarin A coronary event requiring hospitalization during the last 3 months A cerebrovascular event during the last 3 months

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Six and three time schedule<br> | Other: Six and three time schedule<br>* Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.<br>|
| Experimental: Four and two time schedule<br> | Other: Four and two time schedule<br>* Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | Percentage of attenders to screening colonoscopy. | 6 months from the date of sending invitation letter | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening colonoscopy, attendance, response, colorectal cancer