Veteran Primers for CRC Screening

• ClinicalTrials.gov Identifier: NCT04923646
• Recruitment Status: Completed
• First Posted: June 11, 2021
• Last Update Posted: March 22, 2023
• Sponsor: VA Puget Sound Health Care System
• Information provided by (Responsible Party): Alaina Mori, VA Puget Sound Health Care System

Tracking Information

• First Submitted Date: May 19, 2021
• First Posted Date: June 11, 2021
• Last Update Posted Date: March 22, 2023
• Actual Study Start Date: June 30, 2021
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2021)

Return proportion [ Time Frame: 3 months ]

Percent of returned FIT tests

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2021)

Return proportion [ Time Frame: 6 months ]

Percent of returned FIT tests

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Veteran Primers for CRC Screening
• Official Title: Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
• 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:

1. Active arm: Primer

   1. Intervention Type: Other
   2. Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
2. 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Screening
• Condition: Colorectal Cancer

Intervention

Other: Primer

Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

Study Arms

• Experimental: Active
  Primer
  Intervention: Other: Primer
• No Intervention: Control
  No Primer

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2021): 2404
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 19, 2022
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04923646
• Other Study ID Numbers: FIT1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alaina Mori, VA Puget Sound Health Care System
• Original Responsible Party: Linnaea Schuttner, VA Puget Sound Health Care System, Staff Physician
• Current Study Sponsor: VA Puget Sound Health Care System
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ashok Reddy, MD; VA Puget Sound Health Care System
• Principal Investigator: Stefanie Deeds, MD; VA Puget Sound Health Care System

• PRS Account: VA Puget Sound Health Care System
• Verification Date: March 2023