Veteran Primers for CRC Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primer
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Cancer screening, Behavioral economics, Adherence
Eligibility Criteria
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.
Inclusion criteria:
- Veteran
- Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
- At least 1 year of prior data available (evidence of at least one outpatient visit)
- Due for annual colorectal (CRC) screening
Exclusion criteria:
- Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
- Not currently receiving hospice care
- No record of recent death in the administrative data.
- No history of CRC or history of prior colectomy.
Sites / Locations
- VA Puget Sound Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active
Control
Arm Description
Primer
No Primer
Outcomes
Primary Outcome Measures
Return proportion
Percent of returned FIT tests
Secondary Outcome Measures
Return proportion
Percent of returned FIT tests
Full Information
NCT ID
NCT04923646
First Posted
May 19, 2021
Last Updated
March 20, 2023
Sponsor
VA Puget Sound Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT04923646
Brief Title
Veteran Primers for CRC Screening
Official Title
Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System
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 is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening.
Detailed Description
Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:
Active arm: Primer
Intervention Type: Other
Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
Control arm: No primer a. Intervention Type: No intervention
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Cancer screening, Behavioral economics, Adherence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Primer
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Primer
Intervention Type
Other
Intervention Name(s)
Primer
Intervention Description
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
Primary Outcome Measure Information:
Title
Return proportion
Description
Percent of returned FIT tests
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Return proportion
Description
Percent of returned FIT tests
Time Frame
6 months
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
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.
Inclusion criteria:
Veteran
Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
At least 1 year of prior data available (evidence of at least one outpatient visit)
Due for annual colorectal (CRC) screening
Exclusion criteria:
Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
Not currently receiving hospice care
No record of recent death in the administrative data.
No history of CRC or history of prior colectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Reddy, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefanie Deeds, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Veteran Primers for CRC Screening
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