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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711473
• Other study ID #: UPCC 13220
• Secondary ID: 843772
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: November 11, 2022

Study information

• Verified date: January 2023
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Colonoscopy Only
Mailed letter asking participants to complete CRC screening by colonoscopy
• Choice
Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT
• FIT Only
Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT

Locations

Country	Name	City	State
United States	Community Health and Dental Care	Pottstown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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