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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Fecal Immunochemical Tests | Experimental | Mailed fecal immunochemical tests |
|
| Arm 2: Fecal Occult Blood Tests | Experimental | Mailed fecal occult blood tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mailed fecal occult blood tests | Other | Stool blood test |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Screening | Completing fecal blood test within 90 days of enrolling | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Hoffman, MD | New Mexico VA Health Care System, Albuquerque, NM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico | 87108-5153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21348568 | Result | Hoffman RM, Steel SR, Yee EF, Massie L, Schrader RM, Moffett ML, Murata GH. A system-based intervention to improve colorectal cancer screening uptake. Am J Manag Care. 2011 Jan;17(1):49-55. | |
| 20307568 | Result | Hoffman RM, Steel S, Yee EF, Massie L, Schrader RM, Murata GH. Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial. Prev Med. 2010 May-Jun;50(5-6):297-9. doi: 10.1016/j.ypmed.2010.03.010. Epub 2010 Mar 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Fecal Immunochemical Tests | Mailed fecal immunochemical tests Fecal immunochemical testing: Stool blood test |
| FG001 | Arm 2: Fecal Occult Blood Tests | Mailed fecal occult blood tests Fecal occult blood test: Stool blood test |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Fecal Immunochemical Tests | Mailed fecal immunochemical tests Fecal immunochemical testing: Stool blood test |
| BG001 | Arm 2: Fecal Occult Blood Tests | Mailed fecal occult blood tests Fecal occult blood test: Stool blood test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Colorectal Cancer Screening | Completing fecal blood test within 90 days of enrolling | Posted | Number | participants | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Fecal Immunochemical Tests | Mailed fecal immunochemical tests Fecal immunochemical testing: Stool blood test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Hoffman, MD | New Mexico VA Health Care System | 505-265-1711 | 5318 | richard.hoffman2@va.gov |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Mailed fecal immunochemical tests |
| Other |
Stool blood test |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| 0 |
| 202 |
| 0 |
| 202 |
| EG001 | Arm 2: Fecal Occult Blood Tests | Mailed fecal occult blood tests Fecal occult blood test: Stool blood test | 0 | 202 | 0 | 202 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |