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This project aims to evaluate different approaches to increase colorectal cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase response rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including differentiated packaging, sending text reminders, and personalized reminders.
While colonoscopy procedures are recommended by guidelines for early detection of colorectal cancer, colonoscopy access remains limited due to delays in screening due to the pandemic and capacity issues. In this project, we will evaluate different ways of reaching out to eligible patients to encourage them to participate in colorectal cancer screening using fecal immunochemical testing (FIT). In a mailed FIT outreach campaign, we will compare user friendly packaging, text messaging, and personalized reminders to standard outreach with the goal of increasing colorectal cancer screening uptake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Box + Text + Reminder | Experimental | Box + Text + Reminder |
|
| Arm 2: Box + Text + No Reminder | Experimental | Box + Text + No Reminder |
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| Arm 3: Box + No Text + Reminder | Experimental | Box + No Text + Reminder |
|
| Arm 4: Box + No Text + No Reminder | Experimental | Box + No Text + No Reminder |
|
| Arm 5: Standard Mail + Text + Reminder | Experimental | Standard Mail + Text + Reminder |
|
| Arm 6: Standard Mail + Text + No Reminder |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Differentiated Box | Behavioral | Patients will receive mailed FIT kits in a box with differentiated packaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| FIT Completion | Percent of patients who complete FIT | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| FIT Completion | Percent of patients who complete FIT | 6 months |
| Colorectal Cancer (CRC) Screening Completion (Any) | Percent of patients who complete any CRC screening |
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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 |
|---|---|---|---|---|---|---|
| Penn Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40983155 | Derived | Mehta SJ, Nadella P, Shaw PA, Reitz C, Brophy C, Okorie E, Williams K, Snider CK, Peifer MK, Rhodes C, Asch DA. Behavioral Interventions Improve Mailed Colorectal Cancer Screening Among Overdue Patients in a Randomized Trial. Clin Gastroenterol Hepatol. 2026 May;24(5):1442-1451. doi: 10.1016/j.cgh.2025.09.015. Epub 2025 Sep 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Box + Text + Reminder | Box + Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| FG001 | Arm 2: Box + Text + No Reminder | Box + Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| FG002 | Arm 3: Box + No Text + Reminder | Box + No Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| FG003 | Arm 4: Box + No Text + No Reminder | Box + No Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| FG004 | Arm 5: Standard Mail + Text + Reminder | Standard Mail + Text + Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| FG005 | Arm 6: Standard Mail + Text + No Reminder | Standard Mail + Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| FG006 | Arm 7: Standard Mail + No Text + Reminder | Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| FG007 | Arm 8: Standard Mail + No Text + No Reminder | Standard Mail + No Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Box + Text + Reminder | Box + Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FIT Completion | Percent of patients who complete FIT | Posted | Count of Participants | Participants | 4 months |
|
Only All-Cause Mortality monitored/assessed up to 6 months from study start.
Only All-Cause Mortality monitored/assessed up to 6 months from study start. The research solely tested methods of outreach for getting patients to complete mailed FIT for colorectal cancer screening. No drug, medical device, or medical procedure was under investigation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Box + Text + Reminder | Box + Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shivan Mehta | University of Pennsylvania | 215-898-9807 | shivan.mehta@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2022 | Jan 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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| Experimental |
Standard Mail + Text + No Reminder |
|
| Arm 7: Standard Mail + No Text + Reminder | Experimental |
|
| Arm 8: Standard Mail + No Text + No Reminder | Experimental | Standard Mail + No Text + No Reminder |
|
| Standard Mail | Behavioral | Patients will receive mailed FIT in a standard mailing envelope |
|
| Text | Behavioral | Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. |
|
| No Text | Behavioral | Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. |
|
| Reminder | Behavioral | Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
|
| No Reminder | Behavioral | Patients will not receive any mailed letter reminder to complete their FIT kit. |
|
| 6 months |
| FIT Positive Follow-up Scheduling | Percent of patients with FIT+ results that schedule a colonoscopy | 6 months |
| FIT Positive Follow-up Completion | Percent of patients with FIT+ results that complete a diagnostic colonoscopy | 6 months |
| Invalid Address |
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| Ineligible |
|
| BG001 | Arm 2: Box + Text + No Reminder | Box + Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| BG002 | Arm 3: Box + No Text + Reminder | Box + No Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| BG003 | Arm 4: Box + No Text + No Reminder | Box + No Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| BG004 | Arm 5: Standard Mail + Text + Reminder | Standard Mail + Text + Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| BG005 | Arm 6: Standard Mail + Text + No Reminder | Standard Mail + Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| BG006 | Arm 7: Standard Mail + No Text + Reminder | Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. |
| BG007 | Arm 8: Standard Mail + No Text + No Reminder | Standard Mail + No Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Patient Portal Status | Count of Participants | Participants |
|
| Prior Screening (Any) | Count of Participants | Participants |
|
| Insurance Type | Count of Participants | Participants |
|
| Median Household Income | Median | Inter-Quartile Range | dollars |
|
All patients in this study arm received text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 2, 5, and 6).
| OG003 | No Text (Arms 3+4+7+8) | Patients in this study arm did NOT receive any text messaging related to completion of mailed FIT. This combined study arm includes all patients in study arms 3, 4, 7, and 8). |
| OG004 | Reminder (Arms 1+3+5+7) | Patients in this study arm did received a mailed reminder letter related to completion of mailed FIT. This combined study arm includes all patients in study arms 1, 3, 5, and 7. |
| OG005 | No Reminder (Arms 2+4+6+8) | Patients in this study arm did NOT receive any mailed reminder letters related to completion of mailed FIT. This combined study arm includes all patients in study arms 2, 4, 6, and 8. |
|
|
| Secondary | FIT Completion | Percent of patients who complete FIT | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Colorectal Cancer (CRC) Screening Completion (Any) | Percent of patients who complete any CRC screening | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | FIT Positive Follow-up Scheduling | Percent of patients with FIT+ results that schedule a colonoscopy | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | FIT Positive Follow-up Completion | Percent of patients with FIT+ results that complete a diagnostic colonoscopy | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 656 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Arm 2: Box + Text + No Reminder | Box + Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. | 0 | 661 | 0 | 0 | 0 | 0 |
| EG002 | Arm 3: Box + No Text + Reminder | Box + No Text + Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. | 0 | 653 | 0 | 0 | 0 | 0 |
| EG003 | Arm 4: Box + No Text + No Reminder | Box + No Text + No Reminder Differentiated Box: Patients will receive mailed FIT kits in a box with differentiated packaging No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. | 0 | 661 | 0 | 0 | 0 | 0 |
| EG004 | Arm 5: Standard Mail + Text + Reminder | Standard Mail + Text + Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. | 1 | 655 | 0 | 0 | 0 | 0 |
| EG005 | Arm 6: Standard Mail + Text + No Reminder | Standard Mail + Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope Text: Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. | 0 | 656 | 0 | 0 | 0 | 0 |
| EG006 | Arm 7: Standard Mail + No Text + Reminder | Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. Reminder: Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach. | 0 | 653 | 0 | 0 | 0 | 0 |
| EG007 | Arm 8: Standard Mail + No Text + No Reminder | Standard Mail + No Text + No Reminder Standard Mail: Patients will receive mailed FIT in a standard mailing envelope No Text: Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT. No Reminder: Patients will not receive any mailed letter reminder to complete their FIT kit. | 1 | 649 | 0 | 0 | 0 | 0 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |