Colorectal Neoplasms
Conditions
Keywords
screening
Brief summary
We will evaluate if we can increase colorectal cancer screening rates by directly sending screening tests to patients rather than waiting for them to come to clinic visits. We are also evaluating a new test--fecal immunochemical tests--which does not require patients to make dietary or medication changes. We will see if patients are more likely to complete these tests than the standard fecal occult blood tests.
Detailed description
Background: Colorectal cancer causes a substantial burden of suffering in the elderly VA population. Although colorectal cancer screening can reduce both the incidence and mortality from colorectal cancer, screening rates are low for the New Mexico VA Health Care System. Objectives: We propose to use the electronic medical record and a new technology for fecal stool testing to improve screening rates and adherence to screening. Methods: The electronic medical record will be used to identify patients who are eligible for screening but who do not have an immediately upcoming primary care clinic appointment. We will enroll a randomly-selected sample of 800 of these patients who have agreed to participate in the study and mail them stool tests along with instructions and educational information about the benefits of screening. We will compare the proportion of subjects who undergo colorectal cancer screening during the 3-month study period against a randomly-selected sample of 400 eligible patients who will require a clinic visit to initiate screening. Because adherence for fecal occult blood tests is low, we also propose to evaluate a new screening technology--fecal immunochemical stool tests which target intact human hemoglobin. These tests can be performed without requiring patients to follow onerous dietary and medication restrictions. We will evaluate whether screening adherence (proportion completing testing) is higher with fecal immunochemical testing (n = 400) compared to the standard fecal occult blood test (n=400). We will also evaluate the yield of advanced neoplasia for each of the screening tests.
Interventions
OTHERMailed fecal occult blood tests
Stool blood test
OTHERMailed fecal immunochemical tests
Stool blood test
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible for stool-based colorectal cancer screening, followed in primary care clinic
Exclusion criteria
* Need for surveillance or screening colonoscopy * limited life expectancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer Screening | 3 months | Completing fecal blood test within 90 days of enrolling |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Fecal Immunochemical Tests Mailed fecal immunochemical tests
Fecal immunochemical testing: Stool blood test | 202 |
| Arm 2: Fecal Occult Blood Tests Mailed fecal occult blood tests
Fecal occult blood test: Stool blood test | 202 |
| Total | 404 |
Baseline characteristics
| Characteristic | Arm 2: Fecal Occult Blood Tests | Arm 1: Fecal Immunochemical Tests | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 71 Participants | 74 Participants | 145 Participants |
| Age, Categorical Between 18 and 65 years | 131 Participants | 128 Participants | 259 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 8.1 | 63.9 years STANDARD_DEVIATION 7.3 | 63.9 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 202 participants | 202 participants | 404 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 193 Participants | 199 Participants | 392 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 202 | 0 / 202 |
| serious Total, serious adverse events | 0 / 202 | 0 / 202 |
Outcome results
Primary
Colorectal Cancer Screening
Completing fecal blood test within 90 days of enrolling
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Fecal Immunochemical Tests | Colorectal Cancer Screening | 127 participants |
| Arm 2: Fecal Occult Blood Tests | Colorectal Cancer Screening | 112 participants |
Comparison: Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.p-value: 0.0195% CI: [1.04, 2.32]Regression, Logistic