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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Colonoscopy Only; Behavioral: Choice; Behavioral: FIT Only

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 Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pottstown, Pennsylvania, United States, 19465
      • Community Health and Dental Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Colonoscopy Only; Mailed letter asking participants to complete CRC screening by colonoscopy
Experimental: 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.	Behavioral: Choice; Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT
Experimental: 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.	Behavioral: FIT Only; Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: National Comprehensive Cancer Network

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: prevention; colonoscopy; screening; stool testing
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: UPCC 13220; 843772 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No