Back to resultsDoes Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Assessment (CCRAT)
Usual Care (UC)
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring cancer screening beliefs, colorectal cancer screening
Eligibility Criteria
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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Usual Care (UC)
Risk Assessment (CCRAT)
Arm Description
Patients receive standardized general information about colorectal cancer screening over the telephone.
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)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Change in intention to screen at 6 months and 12 months
Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03819920
Brief Title
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Official Title
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 6, 2015 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
January 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
cancer screening beliefs, colorectal cancer screening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
229 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (UC)
Arm Type
Placebo Comparator
Arm Description
Patients receive standardized general information about colorectal cancer screening over the telephone.
Arm Title
Risk Assessment (CCRAT)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Risk Assessment (CCRAT)
Other Intervention Name(s)
CCRAT
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Usual Care (UC)
Other Intervention Name(s)
UC
Intervention Description
Patients receive standardized general information about colorectal cancer screening over the telephone.
Primary Outcome Measure Information:
Title
Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
Description
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)
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT
Description
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)
Time Frame
6 months after intervention
Title
Change in intention to screen at 6 months and 12 months
Description
Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.
Time Frame
Immediate after intervention, 6 months and 1 year after intervention
Title
Colorectal cancer screening rates at 12 months as a function of CCRAT score
Description
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
Time Frame
12 months after intervention
Other Pre-specified Outcome Measures:
Title
Risk perception: Health Belief Model Likert Scale
Description
Differences in perception of one's own risk of colorectal cancer ranging from "very unlikely" (minimum) to "very likely" (maximum), with "very unlikely" representing the most favorable outcome of perceived risk and "very likely" representing the most unfavorable outcome of perceived risk.
Time Frame
Immediate after intervention
Title
Fear: Health Belief Model Likert Scale
Description
Presence of fear of discovering colorectal cancer on performing screening test ranging from "strongly disagree" (minimum) to "strongly agree" (maximum), with "strongly disagree" representing the most favorable outcome of fear and "strongly agree" representing the most unfavorable outcome of fear.
Time Frame
Immediate after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Ladabaum, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Stanford Medicine Box) that is password protected
IPD Sharing Time Frame
2/1/2019-2/1/2021
IPD Sharing Access Criteria
Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Uri Ladabaum can submit a request.
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Links:
URL
https://ccrisktool.cancer.gov/
Description
National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
Learn more about this trial
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?
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