Clinical trial · Interventional
Mailed FIT Outreach 2022
Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach
NCT05341622CI-TRIAL-00079099completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Differentiated Box | Behavioral | — | UNRESOLVED |
| No Reminder | Behavioral | — | UNRESOLVED |
| No Text | Behavioral | — | UNRESOLVED |
| Reminder | Behavioral | — | UNRESOLVED |
| Standard Mail | Behavioral | — | UNRESOLVED |
| Text | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Arm 1: Box + Text + Reminder
- description
- Box + Text + Reminder
- interventionNames
- Behavioral: Differentiated Box
- Behavioral: Text
- Behavioral: Reminder
- type
- EXPERIMENTAL
- label
- Arm 2: Box + Text + No Reminder
- description
- Box + Text + No Reminder
- interventionNames
- Behavioral: Differentiated Box
- Behavioral: Text
- Behavioral: No Reminder
- type
- EXPERIMENTAL
- label
- Arm 3: Box + No Text + Reminder
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMehta 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. PMID 40983155