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Veteran Primers for CRC Screening

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primer
Sponsored by
VA Puget Sound Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Cancer screening, Behavioral economics, Adherence

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 19, 2021
Last Updated
March 20, 2023
Sponsor
VA Puget Sound Health Care System
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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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