Colorectal Cancer
Conditions
Keywords
Cancer screening, Adherence
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: 1. Control arm: No reminder a. Intervention Type: No intervention 2. Arm 2: Automated phone reminder a. Intervention Type: Standard reminder via phone (audiocare) 3. 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)
Interventions
OTHERReminder Phone
Standard reminder via phone (audiocare)
OTHERReminder Text
reminder via text (VEText)
Sponsors
VA Puget Sound Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of returned FIT Kits | three months post randomization | the return rate at three months post randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of returned FIT Kits | six months post randomization | the return rate at six months post randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interim analysis | At 50% (n = 1327) of estimated sample size | z-statistic will be calculated from the proportional difference between the combined treatment groups (all reminders) vs. control |
Countries
United States
Outcome results
None listed