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NCT04941300 · ClinicalTrials.gov registry record · Phase 3
ColoRectal Cancer Screening for Southern California Community Health Centers
A Phase 3 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 3
- Development phase
- 55,999
- Enrollment target
NCT04941300 is a Phase 3 study that has completed, run by University of California, San Diego. The registered enrollment target is 55,999 participants.
The verdict
NCT04941300, a Phase 3 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55,999 participants
- Enrollment target
Study 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-compl
Interventions
- OTHER Mailed FIT Outreach
- OTHER Standardized navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55,999 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04941300
The ClinicalTrials.gov registry entry for NCT04941300 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 55,999 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mailed FIT Outreach is the first listed.
NCT04941300 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04941300 about?
NCT04941300 is a clinical study titled "ColoRectal Cancer Screening for Southern California Community Health Centers". 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 ar...
What is the current status of trial NCT04941300?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55,999 participants. The study started on 2021-06-08. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04941300?
The interventions under investigation include: Mailed FIT Outreach (OTHER), Standardized navigation (OTHER).
Who is sponsoring clinical trial NCT04941300?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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