NCT04941300

ColoRectal Cancer Screening for Southern California Community Health Centers

CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55,999 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Mailed FIT Outreach	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.
OTHER	Standardized navigation	The standardized navigation includes, but is not limited to, the following key components: 1. Identification of individuals with abnormal FIT 2. Results review and colonoscopy order by provider 3. Results reporting to patient 4. Insurance approval for colonoscopy 5. Colonoscopy scheduling 6. Bowel preparation \& colonoscopy completion 7. Colonoscopy results provided to patient and CHC 8. Referral-to-Care for patients with CRC (if necessary)

Timeline

• Start date: 2021-06-08
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-06-28
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States