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| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
| European Union | OTHER |
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Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program.
We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program.
This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone.
Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation of ANL | Experimental | Intervention: Procedure : Implementation of routine Advanced Notification Letter included in Standard Invitation procedure Advanced Notification Letter will be implemented in invitation procedure and send two weeks before Standard Invitation (Standard Invitation will be send six weeks before planned screening colonoscopy) |
|
| No included ANL | Active Comparator | Intervention: Behavioral : No included Advanced Notification Letter Sending Standard Invitation six weeks before planned screening colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of ANL | Other | Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participation rate | A percentage of invitees who undergo the screening colonoscopy. The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power. | three months after receiving invitation |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Estimation of the invitees' response rate to Standard Invitation and Advanced Notification Letter followed by Standard Invitation, before receiving Reminding Letter. | three months after receiving invitation |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of including Advance Notification Letter | Total cost of including Advanced notification letter into the standard invitation procedure of this study group. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karolina Janikowska, MD,MSc | The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland | Principal Investigator |
| Jaroslaw Regula, MD, PhD | The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland | Study Chair |
| Bartlomiej Kocot | The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland | Warsaw | Mazovian | Poland |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| D012004 | Rectal Neoplasms |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| No included ANL | Behavioral | Sending Standard Invitation only six weeks before planned screening colonoscopy |
|
| D009369 | Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |