Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
January 12, 2023 updated by: Shivan Mehta, Abramson Cancer Center of the University of Pennsylvania
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pottstown, Pennsylvania, United States, 19465
- Community Health and Dental Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- At least 1 visit with CHDC in the past 2 years
- 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:
- History of CRC or polyps
- Significant family history of CRC
- History of Inflammatory Bowel Disease or Ulcerative Colitis
- History of colectomy
- History of metastatic cancer
- Current use of Medication Assisted Therapy (MAT)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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.
|
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.
|
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
Time Frame: 6 months from initial outreach
|
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
Time Frame: 6 months from initial outreach
|
The proportion of patients choosing either FIT or Colonoscopy in study arm 2 (Choice)
|
6 months from initial outreach
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.