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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA254515-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.
Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigation Intervention | Experimental | Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer. |
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| Standard of Care Control | Other | Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete colonoscopy within 1 year of the colonoscopy referral | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete colonoscopy within 6 months of the colonoscopy referral | 6 months | |
| Time to completion of colonoscopy or end of follow-up after the colonoscopy referral | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison M Cole, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38615750 | Derived | Keppel GA, Ike B, Leroux BG, Ko LK, Osterhage KP, Jacobs JD, Cole AM. Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening. Contemp Clin Trials. 2024 Jun;141:107539. doi: 10.1016/j.cct.2024.107539. Epub 2024 Apr 12. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2026 | |
| Reset | Jul 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2026 | Jul 6, 2026 |
| 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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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Usual Care Control | Behavioral | Educational brochure about colonoscopy |
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| Number of participants who complete colonoscopy within 9 months of the colonoscopy referral | 9 months |
| Number of participants who have completed colonoscopies with adequate preparation | 1 year |
| Number of participants who have colonoscopies with cecal intubation | 1 year |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006298 | Health Services Administration |