Mailed FIT Outreach 2022
Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach
1 other identifier
interventional
5,460
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started May 2022
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
May 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2022
CompletedResults Posted
Study results publicly available
July 24, 2024
CompletedJuly 24, 2024
July 1, 2024
5 months
April 18, 2022
January 5, 2024
July 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FIT Completion
Percent of patients who complete FIT
4 months
Secondary Outcomes (4)
FIT Completion
6 months
Colorectal Cancer (CRC) Screening Completion (Any)
6 months
FIT Positive Follow-up Scheduling
6 months
FIT Positive Follow-up Completion
6 months
Study Arms (8)
Arm 1: Box + Text + Reminder
EXPERIMENTALBox + Text + Reminder
Arm 2: Box + Text + No Reminder
EXPERIMENTALBox + Text + No Reminder
Arm 3: Box + No Text + Reminder
EXPERIMENTALBox + No Text + Reminder
Arm 4: Box + No Text + No Reminder
EXPERIMENTALBox + No Text + No Reminder
Arm 5: Standard Mail + Text + Reminder
EXPERIMENTALStandard Mail + Text + Reminder
Arm 6: Standard Mail + Text + No Reminder
EXPERIMENTALStandard Mail + Text + No Reminder
Arm 7: Standard Mail + No Text + Reminder
EXPERIMENTALArm 8: Standard Mail + No Text + No Reminder
EXPERIMENTALStandard Mail + No Text + No Reminder
Interventions
Patients will receive mailed FIT kits in a box with differentiated packaging
Patients will receive mailed FIT in a standard mailing envelope
Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.
Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.
Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.
Patients will not receive any mailed letter reminder to complete their FIT kit.
Eligibility Criteria
You may qualify if:
- Patients ages 50-74 with Penn as preferred lab
- Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years
- 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).
You may not qualify if:
- 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
- History of total colectomy, dementia or metastatic cancer
- Currently on hospice or receiving palliative care
- Uninsured or self-pay patients
- Currently scheduled for a colonoscopy or sigmoidoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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. 2025 Sep 20:S1542-3565(25)00835-3. doi: 10.1016/j.cgh.2025.09.015. Online ahead of print.
PMID: 40983155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shivan Mehta
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Shivan Mehta, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 18, 2022
First Posted
April 22, 2022
Study Start
May 27, 2022
Primary Completion
October 13, 2022
Study Completion
December 13, 2022
Last Updated
July 24, 2024
Results First Posted
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share