Veteran Primers for CRC Screening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04923646|
Recruitment Status : Completed
First Posted : June 11, 2021
Last Update Posted : March 22, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Primer||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2404 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial|
|Actual Study Start Date :||June 30, 2021|
|Actual Primary Completion Date :||January 1, 2022|
|Actual Study Completion Date :||January 19, 2022|
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
No Intervention: Control
- Return proportion [ Time Frame: 3 months ]Percent of returned FIT tests
- Return proportion [ Time Frame: 6 months ]Percent of returned FIT tests
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923646
|United States, Washington|
|VA Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Ashok Reddy, MD||VA Puget Sound Health Care System|
|Principal Investigator:||Stefanie Deeds, MD||VA Puget Sound Health Care System|
|Responsible Party:||Alaina Mori, Staff Physician, VA Puget Sound Health Care System|
|Other Study ID Numbers:||
|First Posted:||June 11, 2021 Key Record Dates|
|Last Update Posted:||March 22, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
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