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N/A Completed N=5,460 Randomized Double-blind Prevention

Mailed FIT Outreach 2022

Source: ClinicalTrials.gov NCT05341622 ↗
Enrolled (actual)
5,460
Serious AEs
Results posted
Jul 2024
Primary outcomePrimary: FIT Completion — 469; 470; 558; 381 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
FIT Completion
506; 492; 593; 405; 559; 439
SECONDARY
FIT Completion
506; 492; 593; 405; 559; 439
SECONDARY
Colorectal Cancer (CRC) Screening Completion (Any)
650; 640; 739; 551; 700; 590
SECONDARY
FIT Positive Follow-up Scheduling
26
SECONDARY
FIT Positive Follow-up Completion
23

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05341622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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