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| ID | Type | Description | Link |
|---|---|---|---|
| U54132379 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| San Diego State University | OTHER |
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The purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.
Colorectal cancer (CRC) screening saves lives, but screening rates are low among underserved populations, particularly Latinos. The screening rate in the predominantly Latino population served by San Ysidro Health Center (SYHC, a Federally Qualified Health Center (FQHC)), is just 31%, similar to that reported for Latinos nationally, but lower than the overall national average of 65%. Previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. However, since these have undergone limited evaluation among low income predominantly Spanish-speaking Latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. We hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (IR, consisting of community health worker-delivered in clinic education regarding CRC screening and other components), and b) an outreach strategy (OS, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. To test these hypotheses, we propose a randomized trial comparing usual care, IR, OS, and IR+OS for CRC screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inreach strategy | Experimental | This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. |
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| Outreach strategy | Experimental | This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. |
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| Both Inreach and Outreach strategies | Experimental | This is a combination of the above two strategies: Inreach and Outreach combined. |
|
| Usual care | Active Comparator | Usual care in the clinic using the fecal immunochemical test (FIT) kit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inreach strategy | Behavioral | Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Screening Completion Rate | Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy) | 23 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Gupta, MD | University of California, San Diego | Principal Investigator |
| Sheila Castaneda, PhD | San Diego State University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inreach Strategy | This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit |
| FG001 | Outreach Strategy | This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders |
| FG002 | Both Inreach and Outreach Strategies | This is a combination of the above two strategies: Inreach and Outreach combined. Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders |
| FG003 | Usual Care | Usual care in the clinic using the fecal immunochemical test (FIT) kit. Usual care: Usual care: FIT kit delivery as part of usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inreach Strategy | This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Screening Completion Rate | Completion of any colorectal cancer screening test (FIT, sigmoidoscopy or colonoscopy) | Posted | Count of Participants | Participants | 23 months |
|
6 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 | Inreach Strategy | This consists of a community health worker-delivered in clinic education regrading CRC screening with a fecal immunochemical test (FIT) kit, and telephone reminders. Inreach strategy: Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samir Gupta, MD | UC San Diego | 07/09/2018 | s1gupta@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2015 | Aug 22, 2025 | Prot_SAP_000.pdf |
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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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| Outreach strategy | Behavioral | Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders |
|
| Both Inreach and Outreach strategies | Behavioral | Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders |
|
| Usual care | Behavioral | Usual care: FIT kit delivery as part of usual care |
|
| Outreach Strategy |
This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders |
| BG002 | Both Inreach and Outreach Strategies | This is a combination of the above two strategies: Inreach and Outreach combined. Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders |
| BG003 | Usual Care | Usual care in the clinic using the fecal immunochemical test (FIT) kit. Usual care: Usual care: FIT kit delivery as part of usual care |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Both Inreach and Outreach Strategies | This is a combination of the above two strategies: Inreach and Outreach combined. Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders |
| OG003 | Usual Care | Usual care in the clinic using the fecal immunochemical test (FIT) kit. Usual care: Usual care: FIT kit delivery as part of usual care |
|
|
| 0 |
| 168 |
| 0 |
| 168 |
| 0 |
| 168 |
| EG001 | Outreach Strategy | This consists of mailed invitations to complete screening with an enclosed fecal immunochemical test (FIT) kit and telephone reminders. Outreach strategy: Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders | 0 | 171 | 0 | 171 | 0 | 171 |
| EG002 | Both Inreach and Outreach Strategies | This is a combination of the above two strategies: Inreach and Outreach combined. Both Inreach and Outreach strategies: Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders | 0 | 167 | 0 | 167 | 0 | 167 |
| EG003 | Usual Care | Usual care in the clinic using the fecal immunochemical test (FIT) kit. Usual care: Usual care: FIT kit delivery as part of usual care | 0 | 167 | 0 | 167 | 0 | 167 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |