Re-invitation to Screening Colonoscopy: a Randomized Study

Study Overview
=================
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.

Official Title
-----------------
Re-invitation to Screening Colonoscopy: a Randomized Controlled Trial of Reminding Letter and Educational Intervention on Attendance in Nonresponders to Initial Invitation to Screening Colonoscopy

Conditions
-----------------
Colorectal Cancer, Screening, Patient Participation

Intervention / Treatment
-----------------
* Behavioral: Re-invitation letter
* Behavioral: Invitation to educational meeting


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 |
| --- | --- |
| Active Comparator: Re-invitation letter<br> | Behavioral: Re-invitation letter<br>* Re-invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.<br>|
| Active Comparator: Educational Meeting<br> | Behavioral: Invitation to educational meeting<br>* Invitation will be sent 6 weeks prior to educational meeting date and followed by a reminding letter 3 weeks later. Educational meetings will be held in a local culture developement centers and conducted by a medical team responsible for the Polish Colorectal Cancer Screening Program. The aim of the meeting is to overcome barriers to screening colonoscopy. The program of the meeting is tailored to individual needs, doubts, and concerns of the participating group as assessed using brief survey at the beginning of the meeting. The major points to be discussed are: risk and benefit of screening, colorectal cancer risk, pain and sedation, preparation to colonoscopy, consecutive stages of the procedure, comfort and embarrassment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance to screening colonoscopy | Percentage of invitees attending screening colonoscopy | 6 months from the date of re-invitation or invitation to educational meeting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to the re-invitation letter or invitation to the educational meeting | Percentage of invitees sending back reply form | 3 months from the date of reinvitation letter or date of invitation to the educational meeting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer, Screening, Colonoscopy, Attendance, Participation