Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Choice; Behavioral: Colonoscopy Only; Behavioral: FIT Only

• Registration Number: NCT04711473
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

Detailed Description

The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Study Start: 2021-10-27
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. At least 1 visit with CHDC in the past 2 years
2. Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)

Exclusion Criteria

1. History of CRC or polyps
2. Significant family history of CRC
3. History of Inflammatory Bowel Disease or Ulcerative Colitis
4. History of colectomy
5. History of metastatic cancer
6. Current use of Medication Assisted Therapy (MAT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Choice	Choice	Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.
Colonoscopy Only	Colonoscopy Only	Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.
FIT Only	FIT Only	Participants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.

Primary Outcome Measures

Name	Time	Method
Colorectal Cancer Screening Completion	6 months from initial outreach	Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.

Secondary Outcome Measures

Name	Time	Method
Choice of Colorectal Cancer Screening Test	6 months from initial outreach	The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)

Trial Locations

Locations (1)

Community Health and Dental Care; 🇺🇸 Pottstown, Pennsylvania, United States