Reminder Modality for CRC Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reminder Phone
Reminder Text
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Cancer screening, Adherence
Eligibility Criteria
Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.
Inclusion Criteria:
- Veterans 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 CRC screening
Exclusion Criteria:
- Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.
- No indication of current receipt of hospice care or record of recent death in the administrative data.
- No personal 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 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control arm: No Reminder
Automated phone reminder
Text reminder
Arm Description
Usual care
Standard reminder via phone (audiocare)
Standard reminder via text (VEText)
Outcomes
Primary Outcome Measures
Percentage of returned FIT Kits
the return rate at three months post randomization
Secondary Outcome Measures
Percentage of returned FIT Kits
the return rate at six months post randomization
Full Information
NCT ID
NCT05012007
First Posted
June 22, 2021
Last Updated
May 2, 2022
Sponsor
VA Puget Sound Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT05012007
Brief Title
Reminder Modality for CRC Screening
Official Title
Reminders for FIT (Fecal Immunochemical Test) Kits Via Different Modalities: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
April 26, 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 randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening.
Detailed Description
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual CRC screening.
Veterans 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:
Control arm: No reminder
a. Intervention Type: No intervention
Arm 2: Automated phone reminder
a. Intervention Type: Standard reminder via phone (audiocare)
Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Cancer screening, Adherence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2653 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm: No Reminder
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Automated phone reminder
Arm Type
Experimental
Arm Description
Standard reminder via phone (audiocare)
Arm Title
Text reminder
Arm Type
Experimental
Arm Description
Standard reminder via text (VEText)
Intervention Type
Other
Intervention Name(s)
Reminder Phone
Intervention Description
Standard reminder via phone (audiocare)
Intervention Type
Other
Intervention Name(s)
Reminder Text
Intervention Description
reminder via text (VEText)
Primary Outcome Measure Information:
Title
Percentage of returned FIT Kits
Description
the return rate at three months post randomization
Time Frame
three months post randomization
Secondary Outcome Measure Information:
Title
Percentage of returned FIT Kits
Description
the return rate at six months post randomization
Time Frame
six months post randomization
Other Pre-specified Outcome Measures:
Title
Interim analysis
Description
z-statistic will be calculated from the proportional difference between the combined treatment groups (all reminders) vs. control
Time Frame
At 50% (n = 1327) of estimated sample size
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 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:
Veterans 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 CRC screening
Exclusion Criteria:
Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment.
No indication of current receipt of hospice care or record of recent death in the administrative data.
No personal 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
Reminder Modality for CRC Screening
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