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| ID | Type | Description | Link |
|---|---|---|---|
| 5UH3CA233314-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mailed FIT Outreach | Other | Primer, FIT Kit, Reminders, Abnormal FIT Follow-up |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mailed FIT Outreach | Other | We will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return. |
| Measure | Description | Time Frame |
|---|---|---|
| Screening up-to-date (primary) | Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years). | Three years |
| Colonoscopy after abnormal FIT (primary) | Proportion of patients with abnormal FIT who complete colonoscopy within 6 months | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| FIT Completion | Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months | Twelve months |
| Time to colonoscopy after abnormal FIT | Median time to colonoscopy completion after abnormal FIT |
| Measure | Description | Time Frame |
|---|---|---|
| Repeat screening (exploratory outcome) | Proportion of patients who complete one normal FIT with repeat FIT within12-14 months. | 12-14 months |
Mailed FIT Inclusion Criteria:
Exclusion Criteria:
Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Elena Martinez | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego, Moores Cancer Center | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37802222 | Derived | Castaneda SF, Gupta S, Nodora JN, Largaespada V, Roesch SC, Rabin BA, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Halpern MT, Martinez ME. Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol. Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2025 | |
| Reset | Dec 15, 2025 | |
| Release | May 15, 2026 | |
| Reset | Jun 11, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2025 | Dec 15, 2025 | |||
| May 15, 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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| Standardized navigation | Other | The standardized navigation includes, but is not limited to, the following key components:
|
|
| From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years |
| Follow-up process | Proportion of patients with abnormal FIT with a) colonoscopy ordered; b) insurance approval completed; c) precolonoscopy visit scheduled; d) precolonoscopy visit completed; e) adequate bowel preparation at time of colonoscopy; f) treatment evaluation referral initiated and first visit completed if CRC found. | From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years |
| Jun 11, 2026 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |