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| ID | Type | Description | Link |
|---|---|---|---|
| 843772 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.
The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy Only | Active Comparator | Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling. |
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| Choice | Experimental | Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion. |
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| FIT Only | Experimental | Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy Only | Behavioral | Mailed letter asking participants to complete CRC screening by colonoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Screening Completion | Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately. | 6 months from initial outreach |
| Measure | Description | Time Frame |
|---|---|---|
| Choice of Colorectal Cancer Screening Test | The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice) | 6 months from initial outreach |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health and Dental Care | Pottstown | Pennsylvania | 19465 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38697235 | Derived | Mehta SJ, Palat S, McDonald C, Reitz C, Okorie E, Williams K, Tao J, Shaw PA, Glanz K, Asch DA. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2117-2124.e2. doi: 10.1016/j.cgh.2024.04.003. Epub 2024 Apr 30. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Choice | Behavioral | Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT |
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| FIT Only | Behavioral | Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |