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Clinical Trials/NCT05341622
NCT05341622
Completed
Not Applicable

Pragmatic Trial of Behavioral Interventions to Increase Response to Mailed FIT Outreach

Abramson Cancer Center at Penn Medicine1 site in 1 country5,460 target enrollmentMay 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
5460
Locations
1
Primary Endpoint
FIT Completion
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 27, 2022
End Date
December 13, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shivan Mehta

Principal Investigator

Abramson Cancer Center at Penn Medicine

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

Outcomes

Primary Outcomes

FIT Completion

Time Frame: 4 months

Percent of patients who complete FIT

Secondary Outcomes

  • FIT Completion(6 months)
  • FIT Positive Follow-up Completion(6 months)
  • Colorectal Cancer (CRC) Screening Completion (Any)(6 months)
  • FIT Positive Follow-up Scheduling(6 months)

Study Sites (1)

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