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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Colonoscopy Only
* Behavioral: Choice
* Behavioral: FIT Only


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colonoscopy Only<br>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<br>* Mailed letter asking participants to complete CRC screening by colonoscopy<br>|
| Experimental: Choice<br>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<br>* Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT<br>|
| Experimental: FIT Only<br>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<br>* Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, prevention, colonoscopy, stool testing