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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 : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Alaina Mori, VA Puget Sound Health Care System

Brief Summary:
This is a randomized controlled trial to evaluate the effectiveness of targeted outreach reminder strategies for a population-based, mailed, fecal immunochemistry test kit (FIT) screening program at the VA Puget Sound among average risk patients who are due for annual colorectal cancer (CRC) screening.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Primer Not Applicable

Detailed Description:

This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions at increasing colorectal cancer (CRC) screening rates, within the VA Puget Sound Health Care System. Average risk patients who are due for annual CRC screening (defined as aged 50-75 with no previous history of CRC, not under hospice care, and alive at the time of screening) will be identified through administrative data. All patients who are due for CRC screening will be mailed a fecal immunochemical test (FIT) kit, kit instructions, and a standard introductory letter from the primary care clinics at the VA Puget Sound. Two weeks following the mailing of the kits, patients who have not returned a kit will be identified for participation in the trial.

Patients eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6 ) to the following interventions:

  1. Control arm - receives no reminders,
  2. Arm 2 - receives a standard automated reminder phone call,
  3. Arm 3 - receives an automated reminder phone call with behavioral messaging,

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. Additional exploratory analyses will include sub-group analyses by race/ethnicity and reach. Enrollment in the trial will occur between March 1, 2021 and May 1, 2021.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
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

Arm Intervention/treatment
Experimental: Active
Primer
Other: Primer
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

No Intervention: Control
No Primer



Primary Outcome Measures :
  1. Return proportion [ Time Frame: 3 months ]
    Percent of returned FIT tests


Secondary Outcome Measures :
  1. Return proportion [ Time Frame: 6 months ]
    Percent of returned FIT tests



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Puget Sound Health Care System
Investigators
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Principal Investigator: Ashok Reddy, MD VA Puget Sound Health Care System
Principal Investigator: Stefanie Deeds, MD VA Puget Sound Health Care System
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Responsible Party: Alaina Mori, Staff Physician, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT04923646    
Other Study ID Numbers: FIT1
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaina Mori, VA Puget Sound Health Care System:
Cancer screening
Behavioral economics
Adherence
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases