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This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms:
Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Colonoscopy only outreach and follow-up |
|
| Sequential Choice | Experimental | Colonoscopy outreach + mailed FIT follow-up |
|
| Active Choice | Experimental | Colonoscopy + mailed FIT outreach and follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy only | Behavioral | Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| CRC screening completion | The percentage of participants who successfully complete FIT or colonoscopy | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Choice of screening test | The percentage of participants who choose either screening method (FIT vs. colonoscopy) | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD | University of Pennsylvania | Principal Investigator |
| Chyke Doubeni, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31469393 | Derived | Mehta SJ, Induru V, Santos D, Reitz C, McAuliffe T, Orellana C, Volpp KG, Asch DA, Doubeni CA. Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e1910305. doi: 10.1001/jamanetworkopen.2019.10305. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| Colonoscopy outreach + mailed FIT follow-up | Behavioral | Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit. |
|
|
| Colonoscopy + Mailed FIT outreach and follow-up | Behavioral | Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent. |
|
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |