Colorectal Cancer, Colon Cancer
Conditions
Keywords
prevention, cancer screening, mailed FIT
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDifferentiated Box
Patients will receive mailed FIT kits in a box with differentiated packaging
BEHAVIORALStandard Mail
Patients will receive mailed FIT in a standard mailing envelope
BEHAVIORALText
Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
BEHAVIORALNo Text
Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
BEHAVIORALReminder
Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
BEHAVIORALNo Reminder
Patients will not receive any mailed letter reminder to complete their FIT kit.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Patients ages 50-74 with Penn as preferred lab 2. Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years 3. Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, FIT-DNA in the last 3 years).
Exclusion criteria
1. Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease 2. History of total colectomy, dementia or metastatic cancer 3. Currently on hospice or receiving palliative care 4. Uninsured or self-pay patients 5. Currently scheduled for a colonoscopy or sigmoidoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion | 4 months | Percent of patients who complete FIT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion | 6 months | Percent of patients who complete FIT |
| Colorectal Cancer (CRC) Screening Completion (Any) | 6 months | Percent of patients who complete any CRC screening |
| FIT Positive Follow-up Scheduling | 6 months | Percent of patients with FIT+ results that schedule a colonoscopy |
| FIT Positive Follow-up Completion | 6 months | Percent of patients with FIT+ results that complete a diagnostic colonoscopy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 656 |
| 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. | 661 |
| 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. | 653 |
| 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. | 661 |
| 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. | 655 |
| 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. | 656 |
| 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. | 653 |
| 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. | 649 |
| Total | 5,244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Ineligible | 26 | 21 | 28 | 24 | 29 | 31 | 28 | 26 |
| Overall Study | Invalid Address | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Box + Text + Reminder | Arm 2: Box + Text + No Reminder | Arm 3: Box + No Text + Reminder | Arm 4: Box + No Text + No Reminder | Arm 5: Standard Mail + Text + Reminder | Arm 6: Standard Mail + Text + No Reminder | Arm 7: Standard Mail + No Text + Reminder | Arm 8: Standard Mail + No Text + No Reminder | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 7.2 | 60.0 years STANDARD_DEVIATION 7.4 | 59.7 years STANDARD_DEVIATION 7.4 | 59.6 years STANDARD_DEVIATION 7.5 | 59.8 years STANDARD_DEVIATION 7.3 | 59.1 years STANDARD_DEVIATION 7.1 | 59.9 years STANDARD_DEVIATION 7.3 | 59.5 years STANDARD_DEVIATION 7.2 | 59.6 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 30 Participants | 21 Participants | 32 Participants | 32 Participants | 28 Participants | 27 Participants | 15 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 619 Participants | 620 Participants | 619 Participants | 616 Participants | 601 Participants | 619 Participants | 616 Participants | 615 Participants | 4925 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 11 Participants | 13 Participants | 13 Participants | 22 Participants | 9 Participants | 10 Participants | 19 Participants | 111 Participants |
| Insurance Type Commercial | 388 Participants | 371 Participants | 392 Participants | 369 Participants | 369 Participants | 371 Participants | 360 Participants | 373 Participants | 2993 Participants |
| Insurance Type Medicaid | 77 Participants | 71 Participants | 73 Participants | 80 Participants | 84 Participants | 84 Participants | 91 Participants | 84 Participants | 644 Participants |
| Insurance Type Medicare | 175 Participants | 208 Participants | 172 Participants | 197 Participants | 191 Participants | 186 Participants | 185 Participants | 177 Participants | 1491 Participants |
| Insurance Type Unknown | 16 Participants | 11 Participants | 16 Participants | 15 Participants | 11 Participants | 15 Participants | 17 Participants | 15 Participants | 116 Participants |
| Median Household Income | 76973 dollars | 77091 dollars | 77091 dollars | 76854 dollars | 74349 dollars | 77091 dollars | 76610 dollars | 73762 dollars | 76875 dollars |
| Patient Portal Status Active | 549 Participants | 555 Participants | 544 Participants | 557 Participants | 553 Participants | 556 Participants | 555 Participants | 542 Participants | 4411 Participants |
| Patient Portal Status Not Active | 107 Participants | 106 Participants | 109 Participants | 104 Participants | 102 Participants | 100 Participants | 98 Participants | 107 Participants | 833 Participants |
| Prior Screening (Any) | 188 Participants | 195 Participants | 212 Participants | 192 Participants | 194 Participants | 187 Participants | 210 Participants | 178 Participants | 1556 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 4 Participants | 4 Participants | 3 Participants | 21 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 27 Participants | 35 Participants | 22 Participants | 29 Participants | 26 Participants | 26 Participants | 25 Participants | 220 Participants |
| Race (NIH/OMB) Black or African American | 226 Participants | 221 Participants | 241 Participants | 242 Participants | 239 Participants | 238 Participants | 242 Participants | 229 Participants | 1878 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants | 15 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 39 Participants | 38 Participants | 31 Participants | 52 Participants | 40 Participants | 56 Participants | 30 Participants | 44 Participants | 330 Participants |
| Race (NIH/OMB) White | 357 Participants | 369 Participants | 342 Participants | 342 Participants | 345 Participants | 332 Participants | 349 Participants | 344 Participants | 2780 Participants |
| Sex: Female, Male Female | 376 Participants | 377 Participants | 391 Participants | 388 Participants | 366 Participants | 352 Participants | 375 Participants | 371 Participants | 2996 Participants |
| Sex: Female, Male Male | 280 Participants | 284 Participants | 262 Participants | 273 Participants | 289 Participants | 304 Participants | 278 Participants | 278 Participants | 2248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 656 | 0 / 661 | 0 / 653 | 0 / 661 | 1 / 655 | 0 / 656 | 0 / 653 | 1 / 649 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
FIT Completion
Percent of patients who complete FIT
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Box (Arms 1+2+3+4) | FIT Completion | 469 Participants |
| Envelope (Arms 5+6+7+8) | FIT Completion | 470 Participants |
| Text (Arms 1+2+5+6) | FIT Completion | 558 Participants |
| No Text (Arms 3+4+7+8) | FIT Completion | 381 Participants |
| Reminder (Arms 1+3+5+7) | FIT Completion | 532 Participants |
| No Reminder (Arms 2+4+6+8) | FIT Completion | 407 Participants |
Secondary
Colorectal Cancer (CRC) Screening Completion (Any)
Percent of patients who complete any CRC screening
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Box (Arms 1+2+3+4) | Colorectal Cancer (CRC) Screening Completion (Any) | 650 Participants |
| Envelope (Arms 5+6+7+8) | Colorectal Cancer (CRC) Screening Completion (Any) | 640 Participants |
| Text (Arms 1+2+5+6) | Colorectal Cancer (CRC) Screening Completion (Any) | 739 Participants |
| No Text (Arms 3+4+7+8) | Colorectal Cancer (CRC) Screening Completion (Any) | 551 Participants |
| Reminder (Arms 1+3+5+7) | Colorectal Cancer (CRC) Screening Completion (Any) | 700 Participants |
| No Reminder (Arms 2+4+6+8) | Colorectal Cancer (CRC) Screening Completion (Any) | 590 Participants |
Secondary
FIT Completion
Percent of patients who complete FIT
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Box (Arms 1+2+3+4) | FIT Completion | 506 Participants |
| Envelope (Arms 5+6+7+8) | FIT Completion | 492 Participants |
| Text (Arms 1+2+5+6) | FIT Completion | 593 Participants |
| No Text (Arms 3+4+7+8) | FIT Completion | 405 Participants |
| Reminder (Arms 1+3+5+7) | FIT Completion | 559 Participants |
| No Reminder (Arms 2+4+6+8) | FIT Completion | 439 Participants |
Secondary
FIT Positive Follow-up Completion
Percent of patients with FIT+ results that complete a diagnostic colonoscopy
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Box (Arms 1+2+3+4) | FIT Positive Follow-up Completion | 23 Participants |
Secondary
FIT Positive Follow-up Scheduling
Percent of patients with FIT+ results that schedule a colonoscopy
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Box (Arms 1+2+3+4) | FIT Positive Follow-up Scheduling | 26 Participants |