Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

Study Overview
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Brief Summary
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This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Detailed Description
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Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

Official Title
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Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Risk Assessment (CCRAT)
* Behavioral: Usual Care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient of any participating physician Not having had any colorectal cancer screening test prior Able to speak English Exclusion Criteria: Personal history of inflammatory bowel disease Personal history of colorectal cancer Personal history of Lynch syndrome or Familial Adenomatous Polyposis Have already received colorectal cancer screening

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care (UC)<br>Patients receive standardized general information about colorectal cancer screening over the telephone. | Behavioral: Usual Care (UC)<br>* Patients receive standardized general information about colorectal cancer screening over the telephone.<br>* Other names: UC;|
| Active Comparator: Risk Assessment (CCRAT)<br>Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html) | Behavioral: Risk Assessment (CCRAT)<br>* Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)<br>* Other names: CCRAT;Behavioral: Usual Care (UC)<br>* Patients receive standardized general information about colorectal cancer screening over the telephone.<br>* Other names: UC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT | Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy) | 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT | Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy) | 6 months after intervention | 
| Change in intention to screen at 6 months and 12 months | Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation. | Immediate after intervention, 6 months and 1 year after intervention | 
| Colorectal cancer screening rates at 12 months as a function of CCRAT score | Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion | 12 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer screening beliefs, colorectal cancer screening