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The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval.
Additional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App Intervention | Experimental | Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app. |
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| Standard Support | No Intervention | Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Information via Smartphone App | Other | The educational messages will include information about the meaning of a positive test result, the patient's chances of having a CRC detected on colonoscopy, and the importance of early CRC detection. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood-Based Screening Test (BBST) Follow-Up | Assess the number of patients with a negative BBST result who accept and complete a follow-up BBST. | 1 year after initial result |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Screening Test Preference | Assess patient preference rates and test completion rates for stool tests, colonoscopy, and blood-based CRC screening modalities. | 1 year |
| Screening Rates | Compare the overall screening rates in the study population to a historical cohort in which blood-based testing was not offered as an option. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline BBST Results | Number of positive and negative BBST results at baseline testing. | 1 year |
| Follow-Up BBST Results | Number of positive and negative BBST results at follow-up test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Page E Blas, MA | Contact | 214-820-5424 | page.blas@bswhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center, Baylor Charles A Sammons Cancer Center | Dallas | Texas | 75246 | United States |
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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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Patients testing positive via BBST will be randomized based on clinic location such that half of the patients receive the intervention and the other half do not.
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| 1 year |
| Intervention Efficacy | Assess whether use of a digital patient navigation tool +/- traditional patient navigation leads to an increased rate of completion of colonoscopy in those with a positive blood or stool test. | 1 year |
| 1 year after initial result |
| BBST+ Follow-Up | Number of BBST positives who received follow-up colonoscopy | 1 year |
| BBST+/Colonoscopy- Follow-Up | Percentage of BBST-positive/colonoscopy-negative patients who accept and complete the follow-up BBST after negative colonoscopy. | 1 year after negative colonoscopy |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |